Sunday, June 3, 2012

Celebrating a prospective randomised control trial

Celebrate a prospective randomised control trial

M Felix freshwater
Voluntary Professor of surgery, University of Miami School of Medicine, 9100 s. Dadeland Blvd. Suite 502, Miami, FL 33156-7815, United States

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M Felix freshwater
Voluntary Professor of surgery, University of Miami School of Medicine, 9100 s. Dadeland Blvd. Suite 502, Miami, FL 33156-7815
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Freshwater MF. Celebrate a prospective randomised control trial. Indian J Plast Surg 2012; 45: 38-9

I am writing this comment on April 1, known as the April Fool's Day in the United States. Historically, it is a day of pranks played on people, printing, and is now also online. [1], [2], [3] [4].

If I were to say that was the preceding article of evidence-based medicine of better quality than the latest article on the subject will appear in the Journal, Hand Surgery, you would think that I drag an April Fool's prank you.

It is not a prank. It is the truth. Published ahead of print and available online in the journal of Hand Surgery, but not yet indexed in PubMed, is a retrospective study from Harvard Medical School/Massachusetts General Hospital. [5]

The importance of this study in the Indian Journal of plastic surgery cannot be sufficiently stressed. Why?

Not only is it a higher quality study than that from Massachusetts General Hospital, but is also discovered I, using database PubMed, that this is the first randomized controlled blinded trial to be published in this journal.

It is most impressive that writers began this study, almost ten years ago, before the concept of evidence-based medicine became au courant among our confreres.

One can quibble with certain aspects of that approach, for example, distributing alternating patients to control and treatment arms, pseudo-stickprovsmetoder. [6] in 2012 is random number generators, freely available on the internet. However, the distribution of points worth noting about this study:

That the authors tried to respond to a meaningful clinical question rather than continuing to employ the dogma which they had learned from their professorsThat, the authors continued in an ethical manner by obtaining approval from its institutional ethics committeeThat the authors clearly described the informed consent obtained from their patientsThat the results were measured by an independent therapist who was blind treatment armsThe ethical standards which the authors were included in the Declaration of Helsinki. Only ethical requirement that the authors did not meet, IJPS and Declaration of Helsinki now requires that all prospective trials shall be registered in a publicly accessible database before the first patient enrolled in. [7] the Trial registration is free.

With the wealth of patients who need treatment for their hand problems, Indian plastic surgeons has a golden opportunity to not only help their patients, but also for answering important clinical questions with high-quality, ethics, future, Blind randomised controlled trials. [8]

These authors have Indian pioneers. Others should follow in their footsteps.

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Fat-Derived Stem Cells Show Promise for Regenerative Medicine, Says Review in Plastic and Reconstructrice Surgery (R)

ARLINGTON HEIGHTS, ill., may 29, 2012 (GLOBE NEWSWIRE)--Adipose stem cells (ACSs) — stem cells derived from fat — is a promising source of cells for Use in plastic surgery and regenerative medicine, according to a special review in the June issue of plastic and reconstructive surgery ?, the official medical journal of the American Society of plastic surgeons (ASPS).

However, much more research is needed to establish the safety and effectiveness of any type of ASC therapy in human patients, in accordance with article ASP member surgeon Rod Rohrich, MD University of Texas Southwestern Medical Center, Dallas, and colleagues. Dr. Rohrich is editor in Chief of plastic and reconstructive surgery.

Adipose stem cells – exciting opportunities, but proceed with caution

The authors present an up-to-date review of the research on the science and clinical application of ASCs. Relatively simple derived from human fat, ASCs are "multipotent" cells can induce that develop into other types of cells – not only fat cells, but also bone, cartilage and muscle cells.

Adipose stem cells promote the development of new blood vessels (angiogenesis) and seems to represent a "immune privileged" set of cells that block inflammation. "Clinicians and patients both have high expectations that ASCs may be the answer to cure many recalcitrant diseases or to reconstruct the anatomical defects," according to Dr. Rohrich and other co-authors.

Although the number of studies using ASCs are rising, there are, however, continuing concerns about their "real clinical potential." The reviewers write, "for example, there are questions about the isolation and purification of ASCs and their effect on tumor growth and execution of FDA regulations."

Dr. Rohrich and other co-authors conducted an in-depth review to identify all known clinical trials of ASCs. So far, most studies conducted in Europe and Korea; reflect strict FDA regulations, has only three ASC studies conducted in the United States to date.

Many different uses, but little experience so far

Most ASC clinical trials to date have been carried out in plastic surgery – a field with "unique privileged access to fat tissue." Plastic surgeon-researchers have used ASCs for various types of soft tissue augmentation, breast augmentation (including after implant removal) and the regeneration of fat in patients with abnormal fat loss (lipodystrophy). Studies exploring the use of ASCs to promote healing of difficult wounds have been reported as well. They have also been used as a method for soft tissue engineering and tissue regeneration, with questionable results.

In other specialties, ASCs have been studied for use in the treatment of some blood and immunological disorders, heart neurological and vascular problems, and fistulas. Some studies have explored the use of ASCs to generate new bones for use in reconstructive surgery. Some studies have reported promising preliminary results in the treatment of diabetes, multiple sclerosis and spinal cord injury. No serious adverse events related to the ASCs was reported in any of the groups of studies.

Although many of the results are encouraging, emphasize the reviewers to all these programmes is in its infancy. Around the world, for all uses, less than 300 patients treated with any standard protocol for preparation or clinical applications of ASCs.

There is also no consensus on the number of ASCs are required per treatment, or how many treatments are necessary to show clinical improvement. Consequently, Dr. Rohrich and co-author conclude "further fundamental science experimental studies with a standardized protocol and larger randomized controlled trials must be carried out to ensure the safety and effectiveness of ASCs in accordance with FDA guidelines."

Plastic and reconstructive surgery ? is published by Lippincott Williams & Wilkins, part of Wolters Kluwer Health.

LaSandra Cooper or Marie Grimaldi
American Society of plastic surgeons
847-228-9900
Media@plasticsurgery.org
www.plasticsurgery.org

Plastic and reconstructive surgery

More than 60 years, plastic and reconstructive surgery ? (http://journals.lww.com/plasreconsurg/), a consistently excellent reference for each specialist who uses plastic surgery techniques or work with a plastic surgeon. American Society of plastic surgeons, plastic and reconstructive surgery ?, the official journal provides subscribers with up-to-the-minute reports on the latest technology and monitoring for all areas of plastic and reconstructive surgery, including breast reconstruction, experimental studies, maxillofacial reconstruction, hand and microsurgery, burn repair, and cosmetic surgery, as well as news about medico-legal issues.

About ASP

American Society of plastic surgeons (ASPS) is the world's largest organization for specialty plastic surgeons. Representing more than 7,000 Member Surgeons, the society is recognized as a leading authority and information source on aesthetic and Reconstructive plastic surgery. ASPS comprises more than 94 percent of all specialty plastic surgeons in the United States. Founded in 1931, and represents the society physician certified by the American Board of plastic surgery or The Royal College of Physicians and Surgeons of Canada. ASP advances the quality care to plastic surgery patients by encouraging high standards of training, ethics, physician practice and research in plastic surgery. You can learn more and visit the American Society of plastic surgeons at Facebook.com and Twitter.com PlasticSurgery.org or/PlasticSurgeryASPS/ASPS_news.

This information was brought to you by Cision http://www.cisionwire.com

http://www.cisionwire.com/American-Society-of-Plastic-Surgeons/r/FAT-derived-stem-cells-show-Promise-for-Regenerative-Medicine--Says-Review-in-Plastic-and-reconstruc,c9265633

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Early active mobilisation versus extrinsic extensor tendon immobilisation after repair: A prospective randomised trial

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Early active mobilisation versus immobilisation after extrinsic extensor tendon repair: A prospective randomised trial

RK Patil, AR Koul
Department of Plastic and Reconstructive surgery, Medical Trust Hospital, Cochin, Kerala, India

Correspondence Address:
R K Patil
Department of Plastic Surgery, Jubilee Mission hospital, East Fort, Thrissur, Kerala
India
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DOI: 10.4103/0970-0358.96576

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Background: Whether to splint the extensor tendon repairs or to mobilise them early is debatable. Recently, mobilisation has shown favourable results in a few studies. This study was aimed to compare the two favoured protocols (immobilisation vs. early active motion) in Indian population. Patients and Methods: Between June 2005 and June 2007, patients with extensor tendon injuries in zones V-VIII were randomly distributed in two groups: Group A, early active motion; and group B, immobilisation. Their results at 8 and 12 weeks and 6 months were compared. Results: Patients in early active motion group were found to have better total active motion and early return to work. This difference was statistically significant up to 12 weeks, but not at 6 months. Conclusion: Early active motion following extensor tendon repair hastens patients' recovery and helps patients to gain complete range of motion at earlier postoperative period. With improved grip strength, the early return to work is facilitated, though these advantages are not sustained statistically significantly over long term.

Keywords: Early active mobilisation following extensor tendon repair; early active mobilization; extensor tendon injuries; static splinting of extensor tendons


How to cite this article:
Patil RK, Koul AR. Early active mobilisation versus immobilisation after extrinsic extensor tendon repair: A prospective randomised trial. Indian J Plast Surg 2012;45:29-37
How to cite this URL:
Patil RK, Koul AR. Early active mobilisation versus immobilisation after extrinsic extensor tendon repair: A prospective randomised trial. Indian J Plast Surg [serial online] 2012 [cited 2012 Jun 2];45:29-37. Available from: http://www.ijps.org/text.asp?2012/45/1/29/96576

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The long disputed issue of rehabilitation of extensor tendon repairs in zones V-VII has been concerned with either complete immobilisation of these repairs [1],[2],[3],[4],[5],[6] or mobilisation within the constraints of splint. [7],[8],[9] In recent times, most authors have preferred some form of mobilisation. The regimens employed for the postoperative management of extensor tendon repairs, in recent times, can be grouped into the following categories: 1) Immobilisation with a static splint, [10],[11] 2) early active mobilisation with a flexion blocking splint [12] and 3) dynamic splinting (active flexion and passive extension) using outriggers. [13],[14],[15],[16],[17] Many studies have shown good results with the early mobilisation techniques, however these studies have limitations. Most of these are retrospective observations; few have clubbed cases treated in different institutions; the number of tendons, percentage of patients returning for follow-up and the assessment criteria are all variable. Some prospective studies are without proper controls.

There are very few prospective controlled trials. In a well-cited study, Khandwala et al. [18] have prospectively compared the results of dynamic splinting and early active motion (EAM). They found the results comparable. In another trial, Mowlavi et al. [19] have compared the results of dynamic splinting with immobilisation. They found that while the early results were better in the dynamic group, the results evened out over 6 months. Thus, while the supporters of early mobilisation have increased over time, there is no hard evidence that one method is better than the other.

We decided to undertake this prospective randomised study to compare the results of EAM and immobilisation.

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Patients

This study was carried out at the Department of Plastic and Reconstructive Surgery of Medical Trust Hospital, Cochin, during the study period from June 2005 to June 2007. Sanction was obtained from the Ethics Committee of the hospital before commencing the study. All patients having simple lacerations of extrinsic extensor tendons of the hand in Verdan's zones [18] V-VII were considered for the study. All hands with complex injuries like significant skin loss, bone and/or joint injuries other than simple breaches of the dorsal capsule of the metacarpophalangeal joint (MCPJ) were excluded. Patients with associated flexor tendon injuries, partial tendon lacerations and tendon injuries at more than one level were also excluded. Index and little fingers where only one tendon was injured were also excluded.

Randomisation

Patients being considered for inclusion were explained about the study and two protocols for postoperative rehabilitation. They were told about possible advantages and disadvantages of both treatment regimens. Patients who showed willingness to participate were placed in alternate groups as they presented. Group A patients had static splints while group B patients underwent early active mobilisation (EAM).

Preoperative workup, operative treatment, antibiotic policy, and immediate postoperative positioning were same in both the groups.

Surgical technique

Surgical protocol consisted of debridement of all nonviable tissues, exploration, and assessment of injury. All the tendon repairs were performed with modified Kessler's method, [19] using 4'o polypropylene core suture with buried knots in the center and continuous over and over epitendinous sutures with same material. Immediately postoperatively, the repairs were splinted with volar plaster of Paris slab from proximal forearm to the fingertips. Measurements were taken for the custom-made padded aluminium splint and patients were discharged on the same day or the next day if the associated injuries allowed. Patients were called as outpatient on 3 rd postoperative day for the initial wound inspection and splint application. Patients in both the groups had similar management till this point.

The splint

Custom-made splint consisted of three parts as shown in [Figure 1]a. The assembled splint is shown in [Figure 1]b. During the exercise, patients were instructed to remove the splint and move the fingers through allowed range [Figure 1]c and d, while the angle adjustment of the main block and the wedge was done by physiotherapist during hospital visit. Additionally, only the injured digits were immobilised in group B. Figure 1: (a) Shows different parts of the splint used. Part A is the main block supporting the hand. Part B is the adjustable wedge; the angle between its limbs can be changed to desirable angle as per the patient's need. While part C is for additional dorsal support. All the three parts can be connected with Velcro strap as in (b). (c) represents position of immobilization in group A patients while it also represents resting position between two exercise sessions in group B patients. After removing the wedge, the patient is free to move the fingers up to the main block as shown in (d)

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Mobilisation

The patients in group A (immobilisation) received a static splint [Figure 1]a which was continued unchanged for 4 weeks. Patients were seen at the end of first, second and fourth postoperative weeks for regular wound care. At the end of 4 weeks, the splint was modified by adding an adjustable block (wedge) to allow 0?-45? of movement at MCPJ while the interphalangeal joints (IPJs) were left free [Figure 2]a and b. They were taught to do the mobilisation four times a day after removing the wedge and to replace it after the exercise. In the sixth week, the splint was adjusted to allow 0?-90? of MCPJ movement as many times as possible in a day [Figure 2]c and d. MCPJs were splinted in between periods of exercise from fourth to sixth weeks. Seventh week onwards, the patients were off the splint during daytime. They were allowed to do activities of daily living during day. Protective splinting was continued during night for another 2 weeks. During this period, the patients were specifically advised not to use the involved hand for heavy manual work, to avoid lifting loads and not to do any passive stretching or massaging. After 8 weeks, the splints were discarded and patients were allowed unrestricted use of their hand. Passive stretching was advised, if required, to improve the range of movements. Figure 2: In group A patients, the resting splint is adjusted in the fifth week by the addition of a wedge as shown in (a). The angle between the blades of the wedge is 45? so that while in place, it supports fingers in position of immobilisation. After removal, it allows 45? movements as shown in (b). Resting position of the hand in the sixth week is shown in (c). with the wedge removed. The wedge has been adjusted to allow free IPJ movements. At MCP joints 0?-90? movements - is allowed after removal of wedge as shown in (d)

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For patients in group B (EAM), the initial splint position was as shown in [Figure 3]a(i). This was the resting position for injured fingers between the periods of exercise. In the first week, as shown in the figure, the angle between the two arms of adjustable block is 30?. From 3 rd day onwards, patients were taught to remove the adjustable block (wedge), and try and move fingers actively at MCPJs through 0?-30? (up to the main splint), keeping the IPJs straight [Figure 3]a(ii). Patients were asked to replace the wedge back in place in between the periods of exercise. Three exercise sessions (as advised above), of 10min each distributed evenly over daytime, were advised in the first week (10min ? 3). During the second week, the splints were adjusted to increase the range of movement to 45?-50? [Figure 3]a (iii and iv). The frequency of exercise sessions was also increased (10min ? 4). In the third week, the range was increased to 70? [Figure 3]b (i), and patients were asked to do it five times a day (10min ? 5). At this time, the finger supporting limb of the wedge was cut/moulded just short of proximal interphalangeal joint (PIPJ), thus allowing free unrestricted movement of IPJs at all times [Figure 3]b (i and ii). In the fourth week, the angle was increased to 90? [Figure 3]b (iii) to allow full flexion (90?) at the MCPJs (10min ? 6) and unrestricted IPJ movements [Figure 3]b(iv). In between the periods of exercise, MCPJs were splinted as in [Figure 3]b (iii). During the fifth and sixth weeks, the adjustable block was removed completely during the daytime, allowing free movements within restrains of the splint (0?-90? at MCPJs). Seventh week onwards, the patients followed the same instructions as the group A patients. Figure 3: (a) (i) Shows the resting position of fingers in the first week. The angle between the blades of the wedge is 30? so that while in place, it supports fingers in position of rest. After removal, it allows 30? movements as shown in (ii). Resting position of the hand in the second week is shown in (iii). The wedge has been adjusted to 50? to allow 0?-50? movements at MCPJs as shown in (iv). (b) (i) shows the resting position of fingers in third week, while the MCPJ are immobilized at a position of full extension (0 degrees); IPJs are left free all the time (ii). During exercise the wegde is removed to allow 70 degree movements at MCPJ. Resting position of hand in fourth week (without wedge) is shown in (iii), IPJs are free to be moved all the time. During exercise 0-90 degrees movements is allowed at MCP joints as shown in figure (iv).

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Complete rehabilitation schedule used for both the groups from admission up to 12 weeks has been summarised in [Table 1]. Table 1: Rehabilitation programme in both the groups from day 0 upto 12 weeks.

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Monitoring

Measurements were taken by an independent observer from the Department of Physiotherapy who was unaware of the patients' status (group allocation).

The following parameters were recorded:

The range of active motion at each joint of the injured and non-injured fingers of injured hand was measured by goniometry, weekly from fourth week onwards at each follow-up visit. This was later used to calculate the total active motion (TAM), an aggregate of active flexion range at MCPJ, PIPJ and distal interphalangeal joint (DIPJ) minus the total extension lag at these three joints. It was measured for all fingers separately (injured as well as non-injured). The TAM achieved in injured digits by patients in both the groups was compared with respect to each other at different time intervals (i.e. at 4, 6, 8 and 12 weeks and 6 months). The combined total range of movements of injured and uninjured fingers in these groups was also compared to assess overall hand function. Student's "t" test was applied to the average TAM achieved at different time intervals to know the significance if any.Grip strength (with grip dynamometer) was measured at 8 weeks and 12 weeks in all the included patients. Student's "t" test was used to compare the results.Flexion and extension lag at the end of 12 weeks and at 6 months.Postoperative pain and oedema (subjective analysis by the patient and the observing therapist scored on a scale "0": no oedema or pain to "10": severe pain and swelling with inability to move fingers).Need for any revision surgery.Time taken for return to work.
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Demographic data

During the study period (i.e. June 2005-June 2007), 108 patients with injury to extrinsic extensor tendon to fingers were treated in our department. Sixty-three patients were excluded for various reasons mentioned above. After exclusions, 45 patients with 45 injured hands (119 tendon injuries) were enrolled for the study and were randomised. Twenty-two patients with 58 injured tendons were included in group A (static splinting), while 23 patients with 61 injured tendons were included in group B (EAM). All the study patients completed 12 weeks of mandatory follow-up and none of them were excluded. However, three patients could not be traced for follow-up at 6 months. Details are as represented in consort diagram [Chart 1].

Total active motion

The average TAM achieved at intervals of 4, 6, 8 and 12 weeks from the date of injury (and at 6 months for those who returned) in both the groups for injured fingers and for injured and uninjured fingers combined is presented in [Table 2]. There was significant difference between group A and group B with respect to TAM of at 4, 6, 8 and 12 weeks (P < 0.01), indicating that patients with early motion had superior results. This advantage was, however, not maintained at 6 months [Table 2]. Overall hand function of patients in group B undergoing early motion up to 12 weeks was significantly better when compared to that in patients of group A (P < 0.01). This advantage again was not maintained over long term, and at 6 months, the results were comparable [Table 3]. Table 2: Comparision between TAM achieved in injured fingers in study groups

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Table 3: comparision between TAM achieved in injured and uninjured fingers in study groups

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Grip strength

Grip strength in patients of group A was significantly less as compared to that of patients in study group B at 8 and 12 weeks [Table 4].

There was no extension lag in any of the patients from either group.

Patients in group A complained about pain during the first week that required pain medications. For the next three weeks, they did not have much pain except for some discomfort during dressing change. From the fifth week onwards, however, many of them had severe pain that required pain medicines. Many of them complained of not being able to do mobilisation for the scheduled time (10min). Most of these patients had pain up to 12 weeks (regular follow-up) and it gradually settled when they started working. Patients in group B complained about pain up to 2 weeks and most of them required analgesics before or after the exercise. After the initial 2 weeks, they had minimal discomfort during the exercise. From the fourth week onwards, they had significantly less pain. Oedema in group A patients persisted for about 10 weeks, while in group B patients, it settled much earlier (average 3-4 weeks) (subjective analysis by patient and therapist).

None of the patients had any rupture. No reexplorations were required.

Long term results

Most of our patients reported for long-term follow-up (6 months) [40 patients returned (88.8%), 2 patients returned the questionnaire (4.4%), while 3 patients were lost to long-term follow-up (7.5%)].

Most (42 of 45) of the patients in both the groups were successfully rehabilitated to their pre-injury occupations. The patients in group A, however, returned to full work after an average of 77.47 days (SD = 14.79), while those in group B needed an average of 70.58 days (SD = 11.51). Patients in group A had weakness and difficulty in using the hand for longer period of time, and took longer to get readjusted to their routine work. Patients in group B had comparatively better grip strengths (at 8 and 12 weeks) and did not complain of as many problems. Though patients in group B returned to work earlier, the difference was not statistically significant (P = 0.1135).

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After extensor tendon repair, a period of immobilisation would logically lead to the formation of a strong fibrous union at the repair site, which has less chance of breakage. This approach has the potential disadvantage of causing adhesions around the repair site, leading to limitation of flexion. On the other hand, early mobilisation can potentially result in less adhesions and better range of flexion, but with the risk of weakening the tendon repair leading to possible rupture or scar stretch and extension lag. There have been case series using either of these techniques in the past, [8],[9],[10],[11],[12],[13],[14],[15],[16],[17] but very few randomised controlled trials [18],[19] have been reported.

Many recent authors have demonstrated the usefulness of early motion of some form following extensor tendon repairs in zones V-VI. [11],[12],[13],[14],[15],[16] Prominent studies using early active mobilisation protocols have advocated active flexion and active extension of only IPJs with MCPJs immobilised in neutral position or in slight flexion. [8],[18] Only recently, authors have proposed regimes where controlled active MCPJ extension was allowed [12],[18],[20] for zone V and VI injures. Of these three studies, Evans and Sylaidis have used active flexion and extension of all three finger joints, but when the MCPJs were being flexed, the IPJs were held in extension and vice versa. In the most well-cited study among these, Khandwala et al. [18] presented a prospective randomised trial in 100 patients with extensor tendon injuries in zones V and VI. They were the first to mobilise MCP and IP joints together. In their study, patients were divided into two groups of 50 patients each. One group was managed by dynamic extension splinting and the other by controlled active mobilisation. In the mobilisation group, active flexion of MCPJ was moderated by a blocking palmer splint extending from proximal forearm to just short of PIPJ, while IPJs were mobilised without restrains of splint. They have reported three tendon ruptures after splint application. This study has reported that there is no distinct advantage of EAM over dynamic splinting except the ease to the patient and the therapist.

In our study, we compared the results of immobilisation versus EAM. We selected tendon injuries in zones V-VII as there is lesser implication of length and tension adjustment at this level as compared to the delicate relation of flexor and extensor apparatus in the digits. Active mobilisation used in our study was started with active flexion and extension of MCPJs without IPJ movements for the initial 2 weeks, followed by unrestricted movement at IPJs and specific mobilisation schedule for MCPJs. We felt that flexing MCP and IP joints at the same time may cause unacceptable tension at the repair sites. MCPJs, if immobilised in extension, might lead to disabling stiffness, so they were mobilised first. Immobilisation of IPJs in extension for 2 weeks, on the other hand, was unlikely to cause significant stiffness, hence IPJ mobilisation was started later. This technique practically does not appear to stress the repair sites any more than the dynamic outrigger splints.

Splint designs used in previous studies have been variable. Studies have shown that for injuries in zones V and VI, the wrist should be held in 22? dorsiflexion to produce enough tendon relaxation throughout the range of digital motion. [21] It is also not very clear from the studies in the past as to how much motion is required to promote optimum hand function. Duran and Housur [22] have suggested that flexor tendon adhesions are avoided by permitting a minimum of 3-5mm of glide. If the same can be applied to extensor tendons, Evans and Brukhalter (1986) [23] have suggested that around 38? of finger MCPJ flexion is enough to produce this excursion in repaired extensor tendons. In our study, we started slowly so as to prevent extension lag, a complication of premature stretching of the repair site. We selected a wrist position of 30? dorsiflexion on the basis of previous dynamic excursion studies demonstrating optimum wrist extension that relieves stress upon tendon repair site during motion. [10] By avoiding dynamic splinting, the treatment was made simpler and less expensive. Also, once the angle of the adjustable block was adjusted during review visit, patients only had to remove it, perform exercise and replace the adjustable block back [Figure 1]. Patients could do it on their own without any assistance at home and were very comfortable with the regime.

In the study group, only injured fingers were splinted leaving the uninjured fingers free to move all the time. We observed statistically significant difference in the combined range of motion of injured and uninjured fingers between the two groups up to 12 weeks. The hands in group B experienced less stiffness as compared to those in group A. Early mobilisation and splinting of only injured fingers probably reduces undue stiffness in other fingers and seems to improve overall hand function.

Previous studies have used either Dargan, [8] Miller [3] or TAM [13],[14],[15],[16],[17] systems for the assessment of results. The Dargan system calculates the fingertip to distal palmar crease distance. It is too lenient in its assessment of extension deficit. Dargan himself has shown a diagram indicating how the finger pulp could touch the distal palmar crease with only 60? of MCPJ flexion. [8] Miller has compared the overall movement at injured digit with contralateral normal digit. [3] In this study, we used TAM to assess the results as it has been used in most of the prominent studies in the literature. [13],[14],[15],[16],[17],[18] The extrinsic extensor tendons primarily extend MCPJs, while IPJ extension is primarily done by the intrinsic muscles, though any tendon adhesion over the dorsum of hand is likely to cause restriction of movements at all the finger joints. TAM thus helps in the assessment of the amount of restriction caused by adhesions, while the extension lag mostly reflects the movement/restriction of MCPJs as the intrinsic system (extending IPJs) is unaffected and is comparable in both the groups.

Our findings suggested that patients in group B, i.e. EAM group, had better range of motion when compared with patients in static splinting group (group A). This difference was significant at 4, 6, 8 and 12 weeks, but not at 6 months. This indicates that the range of movement probably increases with passage of time. This probably is because of the stress of the routine work that is much greater and is continued over a longer period of time. This probably works better than specific periods of physical therapy/passive mobilisation that are done during hospital visits or during specific schedule at home. For the same reason, they should be encouraged to return to work as early as possible. Again, probably strong repairs (following prolonged immobilisation) were better to tolerate this excessive stress as felt by authors advocating static splinting [2],[3],[4],[5],[6] (though at the expense of more rehabilitation time, pain and loss of weges).

Stuart (1965) [9] and Mowlavi et al. (2005) [19] have reported no long-term superiority of mobilisation protocols over immobilisation. They also commented that spontaneous improvement in range of motion does occur with passage of time in some patients in the immobilisation group. This probably follows the same logic as in our patients. These improvements are patient dependent. In our study, most of the patients were laborers and were keen about returning to work. If the above-mentioned logic of constant stress over a longer period is true, this explains their improvement following return to work. Our early results (at 4, 6, 8 weeks) are comparable to the results published by Mowlavi et al. [19] However, their study shows significant improvement of ROM by 12 weeks in immobilisation group which compared favourably with mobilisation group. Our patients showed gradual improvement and were comparable at 6 months. In this study, the delay in regaining motion or the stress required for stretching adhesions probably also may be the effect of scarring tendency which may be more in our population, though this would need to be proved by biopsy at various time intervals (that was not done). Contrary to the common perception that the Asian hands are supple, we feel that not all the Asians are blessed with supple hands.

Though TAM, flexion loss, extension loss and grip strength are good indicators of hand function, they may not reflect loss of function at an individual joint or the ability to use tools effectively. As most of these patients were manual workers, we feel that their rehabilitation to work should also be a criterion for final evaluation.

As is true for dynamic mobilisation, patients undergoing early active mobilisation should be well motivated to comply with this demanding postoperative regime. Though the splint and technique is simple and patient controlled, frequent observations are necessary. Repeated observation would help in monitoring the progress and patient's reliability; also in case of complications, it would help us to intervene early. In contrast to previous studies, [18],[24] we found that if the patients are motivated and explained well, they usually are compliant. By making the splinting technique friendlier, the average number of visits could be reduced to 12 in group A patients and 14 in group B patients. Visit at 6 months was optional, but most of them preferred to come back.

Limitations of the study

The method used for randomisation in this study was not ideal; this may introduce bias in the final assessment. Secondly, along with TAM, assessment of movements at individual joints and their statistical comparison would have given more precise information. Also softening of the scar collagen and the long-term results also need detailed studies.

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EAM following extensor tendon repair hastens patients' recovery and helps patients to gain complete range of motion at earlier postoperative period. With improved grip strength, the early return to work is facilitated. Early motion, reduces pain, stiffness, oedema, and helps in better patient rehabilitation. However the long term results (6 months) are not very different.

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Green DP, Rowland SA. Fractures and dislocations in the hand. In Rockwood CA, Green DP, editors. Fractures in adults. 3 rd ed. Philadelphia: JB Lippincott; 1975. p. 225-73.  Back to cited text no. 1
Clarkson P, Pelly A. The general and plastic surgery of the hand. Oxford: Blackwell Scientific Publications; 1962. P. 147-93.  Back to cited text no. 2
Miller H. Repair of severed tendons of the hand and wrist: statistical analysis of 300 cases. Surg Gynecol Obstet 1942;75:693-8.  Back to cited text no. 3
Koch SL. Nerve and tendon injuries. J Am Coll Surg 1943;28:125-6.  Back to cited text no. 4
Bunnell S. Surgery of the hand. 2 nd ed. Philadelphia: JB Lippincott; 1948. p. 340-6.  Back to cited text no. 5
Boyes JH. Intrisic muscles of fingers. In, Bunnell S, editor. Surgery of the hand. 4 th ed. Philadelphia: JB Lippincott; 1964.  Back to cited text no. 6
Couch JH. The principles of tendon suture in hands. Can Med Assoc J 1939;41:27-30.  Back to cited text no. 7
Dargan EL. Management of extensor tendon injuries of the hand. Surg Gynecol Obstet 1969;128:1269-73.  Back to cited text no. 8
Stuart D, Zambia L. Duration of splinting after repair of extensor tendons in the hand. J Bone Joint Surg 1965;47B:72-9.  Back to cited text no. 9
Doyle JR. Extensor tendon- acute injuries. In, Green DP, editor. Operative hand surgery, 2 nd ed. New York: Churchill Livingston; 1988. p. 2045-72.  Back to cited text no. 10
Elliot RA. Extensor tendon repair. In, McCarthy JG, editor. Plastic surgery of the hand. 7 Philadelphia: WB Saunders Company; 1990; p. 4565-92.  Back to cited text no. 11
Sylaidis P, Youatt M, Logan A. Early active mobilization for extensor tendon injuries. J Hand Surg 1997;22B:5:594-6.  Back to cited text no. 12
Hung LK, Chan A, Chang J, Tasng A, Leung PC. Early controlled active mobilisation with dynamic splintage for treatment of extensor tendon injuries. J Hand Surg 1990;15A:251-7.  Back to cited text no. 13
Saldana MJ, Choban S, Westerbeck LP, Schacherer TG. Results of acute zone III extensor tendon injuries treated with dynamic extension splinting. J Hand Surg 1991;16A:77-80.  Back to cited text no. 14
Guinard D, Lantuejoul JP, Gerard PH, Moutet F. Mobilization precoce prot?g?e par appareillage de levame apr?s reparation primaire des tendons extensurs de la main. Ann Chir Main 1993;12:342-51.  Back to cited text no. 15
Ip WY, Chow SP. Results of dynamic splintage following extensor tendon repair. J Hand Surg 1997;22B:283-7.  Back to cited text no. 16
Kerr CD, Burczak JR. Dynamic traction after extensor tendon repair in zones 6, 7 and 8: A retrospective study. J Hand Surg 1989;14B:21-2.  Back to cited text no. 17
Khandwala AR, Webb J, Harris SB, Foster AJ, Elliot D. A comparison of dynamic extension splinting and controlled active mobilization of complete divisions of extensor tendons in Zones 5 and 6. J Hand Surg 2000;25B:140-6.  Back to cited text no. 18
Mowlavi A, Burns M, Brown RE. Dynamic versus static splinting of simple zone V and zone VI extensor tendon repairs: A prospective, Randomized, controlled study. Plast Reconstr Surg 2005;115:482-7.  Back to cited text no. 19
Evans RB. Immediate short arc motion following extensor tendon repair. Hand Clin 1995;11:483-510.  Back to cited text no. 20
Minamikawa Y, Peimer CA, Yamaguchi T, Banasiak NA, Kambe K, Sherwin FS. Wrist position and extensor tendon amplitude following repair. J Hand Surg 1992;17A:268-71.  Back to cited text no. 21
Duran RJ, Houser RG, Stover MG. Management of flexor tendon lacerations in zone II using controlled passive motion postoperatively. In: Hunter HM, Schneider LH, Mackin EJ, Bill JA editors. Rehabilitation of the hand. St Louis: Mosby; 1978.  Back to cited text no. 22
Evans RB, Burkhalter WE. A study of the dynamic anatomy of extensor tendons and implications for treatment. J Hand Surg 1986;11A:774-9.  Back to cited text no. 23
Thomas D, Moutet F, Guinard D. Postoperative management of extensor tendon repairs in zones V, VI, and VII. J Hand Ther 1996;9:309-14.  Back to cited text no. 24


[Figure 1], [Figure 2], [Figure 3]

[Table 1], [Table 2], [Table 3], [Table 4] Top

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Saturday, June 2, 2012

Ghana: 75 Percent of Burns Cases Preventable, Says Medical Director

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Medicinsk direkt?r Rekonstruktiv Plastikkirurgi och Burns centrum av Korle-Bu undervisning, Dr. Opoku Ware Ampomah, har tilldelats problemen med Br?nn f?rvaltning och f?rebyggande brist p? l?mplig utbildning och lagstiftning f?r att begr?nsa burns fall i landet.

Enligt honom har forskning visade att minst 75 procent av br?nnskador fall ?r m?jliga att f?rebygga skador och resultatet av offrets egna insatser, men lagts till att f?rekomsten av br?nnskador fall forts?tter att vara p? uppg?ng, v?rdera januari 2011 till f?rsta kvartalet i ?r, n?r ?ver 850 brinner fall rapporterades till sjukhuset, med 328 upptagits och 90 d?dsfall.

Medicinsk direkt?r talade vid lanseringen av 15-?rsjubileet av Rekonstruktiv Plastikkirurgi och Burns centrum under temat "Spara liv genom effektiv Burns och Trauma Management" p? onsdag i Accra.

Han varnade f?r att landet ?r noga av burns, eftersom Ghana hade v?xt fram som ett oljeproducerande land d?r det finns sv?ra br?nnskador situationer, som han sade, hade redan komplicerade situationen att s?ga, "med transport av olja och gasol produkter ?ver hela landet, en konsekvens av detta finansiella g?va till ghananerna blir allm?nhetens exponering f?r risker och det ?r troligt att v?xa betydligt.

Vara den enda anl?ggningen i Ghana, och f?r ?vrigt den v?stafrikanska subregionen, den tar emot fler patienter ?n b?ten, skapa pl?tslig ?verbelastning. Exempelvis 2011 fanns 7,443 ?ppenv?rden bes?k och 785 antagning, med 1,184 kirurgiska ingrepp och 1 024 sjukgymnastik interventioner.

Under tiden behandlar cCentre villkor s?som burns, skador i ansikte lemmar, nerver, senor, blodk?rl, hudcancer, contractures, lymphoedema, f?delse anomalier som cleft l?pp och gomspalt, handen missbildningar och kosmetiska problem.

Dr. Ampomah klagade arbetskraft underskott av plastikkirurger, Aanesthetist, specialiserade sjuksk?terskor p? burns, kritiska v?rd och v?vnad b?rkraft, sjukgymnaster och st?dpersonal.

Han tillade att de aktuella taxorna som nationella Health Insurance Scheme (NHIS) var otillr?ckliga f?r att t?cka kostnaden f?r behandling, framf?r allt, br?nnskador patienter. -Vi ?r ofta i ett dilemma om hur du sorterar ut fattiglappar och of?rs?krade patienter."

Han v?djade om boende och incitament paket f?r personalen att ?ka deras moraliska.

69-B?dd kapacitet centrum best?lldes i maj 1997 och b?rjade med kirurger fr?n F?renade kungariket och Skottland, och kan nu skryta med en ghanansk fakultet, inte bara ?terge tj?nst, men producerar framtida plastikkirurger f?r landet och Underomr?det som helhet.

Som en del av firandet, skulle centrumet, i samarbete med Ministry of Health, g?ra en kirurgisk upps?kande p? tamales universitetssjukhus i den norra regionen, en h?lsa promenad och offentliga f?rel?sningar.

H?lsov?rdsministern, Mr. Alban Sumana Kingsford Bagbin lovordas centrum och personal f?r det goda arbetet att v?cka hopp till den hoppl?sa, beskriver centrum som en v?rdefull nationell tillg?ng som b?r st?djas av alla.

Han sade att som landet v?xte, det var behovet av att utbilda m?nniskor p? s?ttet att vara s?ker fr?n olyckor. "H?lsa m?ste ses som prioritet i landet," underr?ttade han.

Mr. Bagbin anges att regeringen planerade om f?rdelaktig arbetsvillkor f?r h?lso-och sjukv?rdspersonal, f?r att hindra dem fr?n att resa utanf?r landet f?r gr?nare betesmarker.

Bortsett fr?n att han sade regeringen var ocks? ?tagit sig att utveckla satellit sjukhus att ta belastningen av landets universitetssjukhus.

Ut?ver 161 ambulanser som redan distribuerats i systemet, 200 mer skulle f?rv?rvas n?sta ?r f?r distribution till metropolitan/kommunal och distrikt huvudst?derna i de 10 regionerna.

Ministern lovade GH?? ? 100 000 f?r ?teruppbyggnaden av dess nya intensiv v?rd enhet.

Copyright ? 2012 Ghana kr?nike. Alla r?ttigheter reserverade. Distribueras av AllAfrica globala Media (allAfrica.com). Kontakta upphovsr?ttsinnehavaren direkt f?r r?ttelser – eller f?r beh?righet att publicera eller g?ra andra beh?rig anv?ndning av detta material, klicka h?r.

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Thursday, February 9, 2012

For Soldier Disfigured in Afghanistan, a Way to Return to the World

AppId is over the quota AppId is over the quota So it began: the shock of recognition. Next came what burn doctors call “the mirror test.” As he was shuffling through a hallway at Brooke Army Medical Center in San Antonio, he passed a large mirror that he had turned away from before. This time he steeled himself and looked.

His swollen lower lip hung below his gums. His left lower eyelid drooped hound dog-like, revealing a scarlet crescent of raw tissue. His nostrils were squeezed shut, his chin had virtually disappeared and the top half of one ear was gone. Skin grafts crisscrossed his face like lines on a map, and silver medicine coated his scars, making him look like something out of a Terminator film.

“This is who I am now,” he told himself.

Every severe injury is disfiguring in its own way, but there is something uniquely devastating about having one’s face burned beyond recognition. Many burn victims do not just gain lifelong scars, they also lose noses and ears, fingers and hands. The very shape of their faces is sometimes altered, forged anew in heat and flame.

More than 900 American service members have been severely burned in Iraq or Afghanistan since 2001, typically from roadside bombs, the military says. Almost all receive extraordinary emergency care and rehabilitation at Brooke. But many will never have their faces restored.

Mr. Paulk, though, has come close. After leaving Texas, and the Army, in 2009, his mouth and eye still deformed, he returned home to California and became something of a recluse, hiding beneath hooded sweatshirts, baseball caps and dark glasses when he went out, if he went out at all.

But he found his way to a program at U.C.L.A. Medical Center called Operation Mend that provides cosmetic surgery for severely burned veterans at no cost — and the operations fundamentally realigned his face, restoring not just the semblance of his former visage, but also a healthy chunk of his self-confidence.

He is venturing out again, to bars, beaches and ball games. On Veterans Day last year, Mr. Paulk, 26, rode in the lead car of the New York City parade, his head bared for tens of thousands to see.

“The burns on a soldier’s face are huge: It’s your military uniform and you can’t take it off,” he said. “The surgery changed so much on my face that it completely changed my whole outlook on life.”

The story of Mr. Paulk’s cosmetic and emotional revival says much about the ways private philanthropy can complement the overtaxed military and veterans health care systems. Now in its fifth year, Operation Mend has provided free cosmetic surgery to more than 50 badly burned veterans of the current wars. The program estimates it spends $500,000 on each of its patients.

But the story also underscores the difficulties of bringing private care into the military world. Though Operation Mend’s founder envisioned the program as a model for public-private cooperation in treating wounded soldiers, it remains one of only a few such ventures, which include Center for the Intrepid rehabilitation centers and Fisher Houses for military families.

Part of the problem, said Gen. Peter W. Chiarelli, the outgoing Army vice chief of staff who has embraced Operation Mend, is that many military doctors remain uncomfortable referring patients out of their system, which they view as a protective cocoon for troops and their families. But that attitude is changing, said General Chiarelli, who is pushing for a private program similar to Operation Mend for treating traumatic brain injuries and post-traumatic stress disorder. “Our problems are so big, we have to reach out beyond ourselves,” he said.

Mr. Paulk, who grew up and still lives in the town of Vista in northern San Diego County, joined the Army a year out of high school in 2004, thinking it might help him get a job in law enforcement.

On his first deployment, with a military police unit in eastern Afghanistan in 2007, he was in a Humvee when it struck a buried mine that ignited the fuel tank and instantly killed his team leader. Mr. Paulk regained consciousness 20 feet from the truck, engulfed in flames.

In searing pain yet shivering with cold in the 90-degree heat, an odd question popped into Mr. Paulk’s head as he waited to be evacuated: Do I still have hair? Yes, another soldier said; his Kevlar helmet had saved it. “Maybe,” Mr. Paulk told himself, “the burns aren’t so bad, and I’ll still look like me.”

But it was not to be. By the time he awoke in San Antonio from a medically induced coma, he had already undergone numerous operations and skin grafts to patch his charred face, arms and legs. With his mother’s permission, a surgeon had removed all his fingers, which had been burned black and to the bone and were all but certain to become infected. He had lost 50 pounds in barely four weeks.

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Dr. Hank Chien, a King of Donkey Kong

AppId is over the quota AppId is over the quota That night, a well-rested Dr. Chien, 37, fired up the 30-year-old Donkey Kong arcade game that stands next to the television in his small apartment in Midtown Manhattan. He finished just after midnight with a score of 1,061,700.

“New world record,” Dr. Chien, a plastic surgeon, yelled while clapping for himself.

All this was captured by a video camera recording the game for proof of the record, which eclipsed the legendary Billy Mitchell’s longstanding high score, 1,050,200. But Mr. Mitchell struck back, and on July 31 he wrested the title back with 1,062,800. A month later, another Donkey Kong titan, Steve Wiebe, set a record with 1,064,500. In February, Dr. Chien set the current record, 1,090,400, at the Funspot arcade in New Hampshire, lifting him into the Guinness World Records 2012 Gamer’s Edition.

“It is a good feeling to know you’re the best in the world at something,” he said, “but one thing about Donkey Kong, you know there are people out there trying every day to break your record.”

Dr. Chien is the middle child among three boys, and moved here from Taiwan at age 2 with his family. He grew up in Forest Hills, Queens, and attended Stuyvesant High School and then Harvard, where he was a math and computer science major. He graduated from the Mt. Sinai School of Medicine and now has a private practice in Flushing, Queens, with a mostly Chinese-immigrant clientele.

Dr. Chien specializes in reshaping his patients’ eyes to create a crease in the upper eyelid. Some patients select him after hearing about his Donkey Kong prowess. This is not so silly, he said, since good gamers make good surgeons and vice versa. Also, compared to the pressure of competitive Konging, he said, eyelid surgeries and tummy tucks are a breeze.

“For both gaming and surgery, you have to have a focused personality and be very precise,” he said. “They both take foresight and good reflexes, and a lot of strategy and planning and timing.”

Still, Dr. Chien keeps no Donkey Kong machine in his office, a snazzy, spalike suite trimmed with frosted glass, high up in a building just off teeming Main Street.

He got hooked on Donkey Kong after seeing “The King of Kong: A Fistful of Quarters,” the popular 2007 documentary about competitive practitioners of this classic arcade game, which pits a large ape called Donkey Kong against Mario, Nintendo’s famous Italian-American plumber-hero. Dr. Chien started playing first on his home computer, and then on the only Donkey Kong machine he could find in the city: at Barcade in Williamsburg, Brooklyn, with its rows of retro video games and array of micro-brews.

There, on Wednesday night, he chatted with the bartender, Alexis Neophytides, who — this being Williamsburg — is also a filmmaker. She wound up making a short documentary about Dr. Chien last year: “Doctor Kong: Cutting Up the Competition.”

“Hank is royalty here,” said George Leutz, 37, a customer at Barcade. “When he walks in, you hear the whispers going around, ‘Hey, that’s Hank Chien.’ ”

Dr. Chien eyed the Donkey Kong game against the wall, and a woman at the bar seemed to automatically pull a quarter out of her handbag and press it into his palm. Dr. Chien pumped it into the machine and he was off, hurdling barrels rolled at him by Donkey Kong.

The woman with the quarters walked over — she was Dr. Chien’s girlfriend, Youmee Im, 33, a finance executive — and when Dr. Chien got too distracted, she finished his sentences for him.

His left hand jiggled the directional knob, and his right hand jabbed at the jump button, maneuvering the Mario character up a course of inclines and ladders to try to rescue the damsel in distress from the big gorilla. The way the game is set up, the player never gets the girl, but Dr. Chien did manage to win over Ms. Im, a pretty mean Centipede player herself, with his gaming prowess, after impressing her on dates two years ago.

At the bar, Mr. Leutz said he was inspired by Dr. Chien to go after one of the most enduring marks in gaming: a 1983 world record of 33,273,520 points on one quarter in Q*bert, which requires about 70 hours of continuous play. He recently logged 57 hours straight before collapsing, but for his next attempt, he wants Dr. Chien to surgically implant a catheter to reduce the need for bathroom breaks. They discussed other surgical procedures that might help hardcore gamers.

“Cut my eyelids off,” Mr. Leutz yelled, and everyone laughed — Dr. Chien loudest of all.

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Wednesday, February 8, 2012

France Recommends Removal of Suspect Breast Implants

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While trying to dampen fears that the implants were linked to any kind of cancer, the French health minister, Xavier Bertrand, recommended that recipients have an “explant” procedure as a preventive, nonemergency measure, even if there were no clinical indications that the implants had been leaking substandard silicone. Medical experts said they were unable to think of any prior action on implants on the scale of the French decision.

The implants — made by a French company, Poly Implants Proth?ses, that was closed last year — used an inferior, industrial-grade silicone and are more likely to rupture or ooze than those made from surgical silicone. The French authorities stressed that the leaked gel carries no known link to cancer, focusing instead on how it can irritate body tissues and cause damaging inflammation.

Questions over how low-grade silicone could have gone undetected in hundreds of thousands of implants sold in Western Europe, Australia and South America come on the heels of France’s largest public health scandal in years. That involves a diabetes medication, Mediator, that was also used as a diet drug. It remained in circulation despite at least a decade of warnings, and health officials say it may have caused as many as 2,000 deaths. The maker, Servier, has been charged with defrauding the health-care system and is being investigated for consumer fraud and manslaughter.

No PIP implants were known to have been used in the United States, but there are concerns over an unknown number of women who traveled to South American for less-expensive implants. So far, no country has reported a rupture rate as high as France’s — 5 percent — and most have issued statements meant to reassure implant recipients.

Anxieties rose sharply last month when a French woman whose implant had ruptured died from a rare cancer called anaplastic large-cell lymphoma, and French media reported that she was the eighth woman with the PIP implants to have died of cancer, a figure for which the statistical significance is unclear.

On Friday, the health authorities in Britain, where some 40,000 women received the implants, said it was not recommending “routine removal. ”

“We recognize the concern that some women who have these implants may be feeling, but we currently have no evidence of any increase in incidents of cancer associated with these implants and no evidence of any disproportionate rupture rates other than in France,” the British agency said in a statement.

In Brazil, where about 25,000 implants were used, the National Agency of Sanitary Vigilance recommended that recipients be examined by their doctors. Chile’s Public Health Institute asked doctors who performed implants to contact patients to explain the emerging concerns.

The healthy ministry in Venezuela, one of the region’s largest plastic surgery markets, did not comment, nor did that in Colombia, where nearly 15,000 women have had PIP implants.

Breast implants have had a contentious history, with critics saying they are overused and that women in the pursuit of a narrowly defined ideal of beauty end up subject to uncertain dangers from silicone leaks, including auto-immune problems and what animal studies suggest are possible links to cancer. In the United States, a 14-year moratorium in the United States on all silicone implants was lifted only in 2006, after two decades of litigation in American courts failed to show a conclusive link to cancer in humans. The United States Institute of Medicine and the Food and Drug Administration eventually determined that there was no evidence that standard silicone implants were harmful.

A spokeswoman for the French health products safety agency, known as Afssaps, said it was possible that the rupture rates in other countries were lower because reporting was still low, or because complaints had not yet reached some governments.

“We began in March 2010 to alert the authorities in the countries that had imported those implants,” she said. “But the question is whether they passed on the information to the population. We don’t know.”

France will foot the bill for the implant removals, but will only pay for new implants in women who had them for reconstructive surgery after breast cancer. Women who choose not to undergo the removal should have an ultrasound examination every six months, the authorities said, and should remove any implant that ruptures.

Some foreign doctors expressed approval for the French approach.

Ravi Somaiya contributed from London, Simon Romero from S?o Paulo, and Gardiner Harris from Washington.

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Non-Specialists Expand Into Lucrative Cosmetic Surgery Procedures

AppId is over the quota Vad hon inte inser var att hans certifiering i ?NH — ?ra, n?sa och hals — inte plastikkirurgi. Resultatet var mindre ?n idealisk: tjock ?rr p? hennes tempel och en v?gig buken.

"Jag var tvungen att anv?nda mitt sparande f?r att f? verkliga plastikkirurg att fastst?lla vad han gjorde till mig," sade Joan, som bad att hennes efternamn inneh?llas f?r att skydda sin integritet. "Jag har en M.B.A. Jag ?r inte dum. Men n?r l?karen har en trevlig klinik och alla dessa examensbevis och certifieringar p? v?ggen, du tror att han vet vad han g?r.

Med fallande f?rs?kring ?terbetalningar, utvidgar fler l?kare, oberoende av specialitet, sin praxis att inkludera lukrativa kosmetiska f?rfaranden som betalas ut av kontant av patienter. Nu ?r det vanligt att hitta gynekologiska erbjuder breast augmentation, ?gonl?kare g?ra Fettsugning, ens familj praxis l?kare ger Botox injektioner.

Resultatet ?r enligt certifierade plastikkirurger, ett ?kande antal missn?jda, ?ven vanst?llda, patienter.

"Allm?nheten beh?ver skyddas fr?n l?kare som inte ?r uppriktiga om vad styrelsen certifieringar de har," sade Dr. Malcolm Z. Roth, chef f?r plastikkirurgi i Albany Medical Center i Albany och ordf?rande i det amerikanska samh?llet av plastikkirurger.

Medlemmar av samh?llet som h?vdar det har funnits en v?g i patienter beg?r revisionary kirurgi – ?tg?rder f?r att ?ngra skador som orsakats av klantiga f?rfaranden. "Jag ser fall s? h?r en vecka nu, n?r ett par ?r sedan jag knappast s?g n?gon," sade Dr. Patti Flint, plastikkirurg i Mesa, Ariz.

Men m?nga av dessa nya alternativa ut?vare s?ga att traditionella plastikkirurger helt enkelt f?rs?ker skydda sina lukrativ handel. "F?r en viss grupp att f?ra en turf slaget och s?ga av ekonomiska sk?l att de ?r de enda som p? ett s?kert s?tt kan utf?ra kosmetiska f?rfaranden ?r hyckleri och grovt osant," sade Dr. Angelo Cuzalina, rival American Academy of kosmetisk kirurgi, ordf?rande best?r fr?mst av l?kare som inte ?r inriktning plastikkirurger.

Cirka 80 procent av licensierade l?kare f? en specialitet certifiering av en av 24 styrelser som godk?nts av amerikansk styrelse av medicinska specialiteter. Detta kr?ver en minst tre?rig vistelse i omr?det valda koncentrationen, plus omfattande muntliga och skriftliga examina.

Det finns inga lagar i USA som kr?ver l?kare praxis endast inom f?lten specialitet i vilken de har utbildats. Dr. Cuzalina, till exempel var f?rst inriktning som en oral och maxillofacial kirurg och sedan avslutat ett yearlong stipendium p? en kosmetisk kirurgi klinik.

-Med min erfarenhet jag inte tror mig som en muntlig kirurg l?ngre,"sade han.

Bara Texas, Kalifornien, Louisiana och Florida mandat att l?karna vara best?mda i sin reklam om vilka specialitet styrelsen certifieringar de har. N?gon annanstans f?r s?ger bara att de ?r "inriktning".

Ingen vet hur m?nga l?kare praktisera utanf?r deras specialitet; de beh?ver inte rapportera till den myndighet som tillsyn att de g?r s?. Och l?kare som utf?r kosmetiska f?rfaranden ?r inte skyldiga att rapporten komplikationer.

Kosmetisk kirurgi oreglerat art ?r fortfarande, att h?ja oro. Michael Freedland, medicinsk felbehandling advokat i Weston, Fla., sade att han hade sett en stadig ?kning av antalet patienter arbetsof?rm?gna eller ens f?rolyckas av kosmetisk kirurgi som utf?rs av okvalificerade l?kare sedan 2008.

-Inte bara utbildas l?karna inte korrekt i plastikkirurgi, men de ?r ocks? verksamma i anl?ggningar, liksom garvning salonger och med SpA, som inte ?r utrustade f?r att hantera en medicinsk n?dsituation,"s?ger han. "Det b?sta de kan g?ra f?r dig om saker g?r fel ?r samtal 911, och ibland de g?ra ens inte."

Statliga medicinska myndigheter ?verensst?mmelsen inte d?dsfall eller skador p? vilken typ av l?kare deltar. M?nga plastikkirurgi patienter ?r hur som helst, liksom Joan, alltf?r generad ?ver att filen formella klagom?l.

"En l?kare kan vara bra och v?lutbildade inom hans eller hennes specialitet, men det tar mer ?n ett helgen seminarium att uppn? h?jdpunkter i plastikkirurgi," sade Dr. Joel Aronowitz, plastikkirurg i Los Angeles som ocks? ?r en klinisk Adjungerad professor p? University of Southern California.

Han noterade att blivande kosmetiska kirurger f?r delta i helgen fortsatta medicinska utbildning kurser, vissa h?lls ombord p? kryssningsfartyg, d?r de l?rs att utf?ra Botox och fyllnadsmedel injektioner, Fettsugning och breast augmentation. Kurserna ?r ofta l?rt av l?kare som sj?lva inte ?r certifierade av den amerikanska styrelsen av plastikkirurgi, sade han.

M?nga s?dana l?kare h?vdar certifiering av styrelser som har namn som liknar till den amerikanska styrelsen av plastikkirurgi men inte godk?ndes av amerikansk styrelse av medicinska specialiteter. -De har l?gre krav och ?r inte s? str?nga, sade Dr. Aronowitz. "Det finns en anledning som de inte ?r erk?nda styrelser."

Dr. Cuzalina sade att lobbying fr?n plastikkirurger f?rhindras grupper som hans fr?n ansluta till styrelsens medicinska specialiteter.

Dr. John Santa, en l?kare och chef f?r konsumenten rapporter h?lsa omd?men Center, som r?ntesatserna f?r sjukhus och ger r?d om hur du v?ljer l?kare, designad att blivande patienter kontrollera staten medicinska styrelser f?r eventuella disciplin?ra ?tg?rder, och s? ser du om en l?kare har ocks? full drift, beh?righeter p? ett visst sjukhus.

"Framf?r allt jag tror sunt f?rnuft ?r i ordning," sade han. "Jag skulle vara misst?nksam mot alla som ?r verksamma s?tt utanf?r hans eller hennes specialitet, och alltid f? ett andra yttrande.

"N?r det finns n?gon f?rs?kring," tillade han, "?r det verkligen vilda v?stern och det finns ingen sheriff i stan."

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From Eye and Hair Surgery to Toasty Toes - Beauty Spots

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Tuesday, February 7, 2012

Frenchwomen Worry About Suspect Breast Implants

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Rachel Rodriguez, a 35-year-old mother who sells shoes in this quiet city on France’s Atlantic coast, has stopped exercising. And, she said, she developed psoriasis on her scalp from anxiety and lost 24 pounds in a month.

“She is glued to the Internet, doesn’t sleep or enjoy life anymore,” said her husband, Jean-Marc, a security guard. “We’ve fallen into real paranoia.”

Ms. Rodriguez is one of the 30,000 Frenchwomen who were given the implants, which were filled with an industrial-grade silicone and are more likely to rupture or ooze than those made from surgical silicone. About 300,000 women across 65 countries received the implants.

The problems with the implants were first revealed in 2010, when the French government ordered their withdrawal from the market, though at the time it did not recommend their removal from those who already had them. But women with the implants got a fresh jolt in November news broke that a woman whose suspect implants had leaked had died of a rare form of lymphatic cancer.

While French health officials said the gel carried no known link to cancer, the news had many women here hurrying to have their implants removed, lest they rupture and spread a potentially toxic gel in their bodies.

?milie Germain, who received the faulty implants in 2009, said she had noticed several lumps in her breasts and often felt a burning sensation. But she was not sure what to make of it.

“I feel like I’m having symptoms that aren’t real,” she said. “It certainly comes from anxiety.”

In December, French health officials recommended that women have the implants removed as a preventive measure. The government has said that it will cover the cost, but that it will pay for new implants only for women who had them for reconstructive surgery after breast cancer.

“Many women who come to us can’t pay for new breasts,” said Muriel Ajello, who leads a group defending affected women. “Those people are our priority.”

The women primarily fear for their health. Even so, many also joined Ms. Ajello’s association to be recognized as victims and fight against the perception that they were somehow at fault for having had the surgery in the first place. They pointed out that many women have implants after a mastectomy, or after extensive breastfeeding that can shrink the breast, and not just for vanity.

“We aren’t bimbos,” Ms. Rodriguez said. “We aren’t psychologically weak people, either.”

Ms. Rodriguez and the others criticized health officials and surgeons for not immediately alerting them to the potential risks. Some women even said that their surgeons had been absent or on vacation since news of the scandal broke. Others held the government responsible for waiting more than a year after the offending gel was withdrawn from the market before taking preventive measures.

They often compare the implant scandal to the outrage in the 1990s over contaminated blood, when the news media discovered that France’s National Center of Blood Transfusion had knowingly distributed AIDS-contaminated blood products to hemophiliacs in 1985. That case brought criminal prosecutions.

“We found out the truth only 15 years after it happened,” Ms. Rodriguez said. “I fear that this is going to happen with the implants.”

Many surgeons have tried to calm fears, saying that there was no evidence that the gel was harmful. But women with the implants said that they knew very little about the product.

“There hasn’t been any reliable medical expertise about it,” Ms. Germain said of the gel, adding that her surgeon had on his desk the files of 200 women waiting to have their implants removed.

“There are many rumors, and sometimes nonsense,” said a surgeon who had given several women the implants. “What struck me most is that no one until recently asked us to keep the implants with us for further analysis,” he said. He agreed to speak only if his name was not used, because of the possibility of litigation over the issue.

Annie Mesnil, a 65-year-old graphic designer and mother of three, had her right breast removed after she received a diagnosis of breast cancer in 1999.

“I couldn’t imagine myself living with one of my breasts missing,” she said.

She happily accepted her surgeon’s suggestion to have implants and asked no questions. “He said they had satisfying results, and I trusted him.”

In March 2010, when she found out that the company had stopped its production of implants, she had a scan that showed nothing wrong. But because she had already suffered from heavy chemotherapy and wanted to take no chances, she picked another surgeon and had her implants removed in June.

But the implants had already leaked. “They had ruptures of more than 10 centimeters deep in different places,” said Dr. Benjamin Pulvermacker, the surgeon who operated on Ms. Mesnil. “The gel had leaked, and I had to clean up the entire space where the implant was placed.”

Ms. Mesnil said that she felt like she has had a sword of Damocles over her head for the past six months, anxious about the consequences of the leakage. “The gel can infiltrate the body tissues, and no one knows if we can take all of it out,” she said.

Ms. Rodriguez has been coping with the same feeling of helplessness. She is counting the days before she has her surgery on Jan. 25. This time, she said, her surgeon told her of a Web site where she could choose different varieties and brands of implants.

“I’ll pick ones made of physiological salt solution,” she said. “They are translucent, and you can easily see through them.”

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Health breast implants concerns over suspected French spread abroad

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It is unclear whether there are health risks posed by the substandard silicone used in the implants, and the French government is expected to decide soon whether to require as many as 30,000 women in France to have their implants removed.

If the government mandates the removals, it will also pay for the procedures, though not for replacements. Regulators will have to weigh whether the known risks associated with removing the implants outweigh the uncertain risks and modern associated with leaving them intact.

The British health authorities on Wednesday sought to calm the women's fears, saying that there was no evidence that the suspect implants, which were manufactured by Poly Implants Proth?se, a company known as PIP, had caused cancer. They urged women who had received them to take any concerns to their surgeons, but they also said, "There is currently no evidence to support routine removal" of the implants.

Britain's surgical Association also tried Wednesday to "soothe anxiety. "The message here is not to panic," said a consultant plastic surgeon, Mr Douglas McGeorge, who spoke for the British Association of Aesthetic Plastic Surgeons.

Silicone implants have had a contentious history, with the United States imposing a 14-year moratorium on their use that ended in 2006, after years of lawsuits contending that they had caused cancer. None of PIP's implants appear to have been sold in the United States.

The Institute of Medicine and the Food and Drug Administration eventually determined that there was no evidence that silicone implants were harmful.

Concerns over the silicone in the suspect implants began to build last year, when PIP was shut down and prosecutors began investigating the company for possible fraud. The French authorities said the implants had been rupturing at a rate double the industry average, the French media reported.

But the concerns over the company's implants caught the attention of European health officials after a woman whose implants had ruptured died last month from a rare cancer called anaplastic large-cell lymphoma.

The French media reported that she was the eighth woman with an implants manufactured by the company to have died of cancer, although the statistical significance of that is unclear.

French prosecutors have said that Poly Implants Proth?se substituted a cheap, industrial-grade silicone for medical-grade silicone that is the industry standard. The French authorities have said the substandard product causes inflammation to body tissues when implants are compromised. But so far, they have emphasized, there is no evidence linking it to cancer.

"In case of rupture, you'd have a dangerous quantity of silicone into your body," said Laurent Lantieri, a plastic surgeon at a hospital near Paris.

H?l?ne Guillois, 29, a nutrition student who lives in northern France, said she had the company's devices implanted seven years ago.

"I'm worried, because of the possible damage this could cause," Ms. Guillois said. "No one is really capable of saying" what will be the effects. Maybe we'll see in 10 years or so. Like all the big French medical scandals. "

Breast implants, which are essentially small silicone rubber bags filled with a material, typically silicone or a saline solution, are used after breast cancer surgery or simply for cosmetic purposes.

More than 1,000 of the estimated 30,000 French women fitted with the devices have experienced ruptures or leakage. Tens of thousands more in other countries have had the company's devices implanted, because PIP exported 80 percent of its products, many of them to Britain, Spain and Latin America.

More than 40,000 British women are estimated to have received the company's implants.

The implants were also used in Brazil, Argentina, Chile, Colombia and Venezuela. In Brazil, the National Agency of Sanitary Vigilance trade-off prohibited the importation and use of the implants in April 2010, after concerns about their safety emerged in France.

Chile's Public Health Institute asked the estimated 1,000 or so women thought to have implants from the French company to contact their doctors so the implants could be removed if ruptures occurred. Otherwise, Chilean officials asked the women with the implants to undergo annual exams.

Sebasti?o Guerra, the director of the Brazilian Society of Plastic Surgery, said, "We do not have significant reports of either ruptures or rejections or even cancer associated with those PIP implants, and we don't know why there is this difference with respect to the French news."

Prosecutors in Marseille have been investigating the company for possible fraud and reckless endangerment. They say it cut costs over the last decade by using an industrial silicone gel that was not approved for medical use and that cost a fraction of the medical-grade materials.

Several hundred thousand of the implants had been manufactured by the time issues were raised early last year about their quality.

Yves Haddad, a lawyer for the company's founder and chairman, Jean-Claude Mas, said there was no evidence that the product, "even if it was unapproved, is dangerous for health."

The Marseille prosecutor's office declined to comment.

Reporting was contributed by Ravi Somaiya from London; Simon Romero from S?o Paulo, Brazil; Gardiner Harris from Washington; and Jon Moriconi from Rio de Janeiro.

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