Thursday, February 9, 2012
For Soldier Disfigured in Afghanistan, a Way to Return to the World
Dr. Hank Chien, a King of Donkey Kong
Wednesday, February 8, 2012
France Recommends Removal of Suspect Breast Implants
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.
Non-Specialists Expand Into Lucrative Cosmetic Surgery Procedures
"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."
From Eye and Hair Surgery to Toasty Toes - Beauty Spots
Tuesday, February 7, 2012
Frenchwomen Worry About Suspect Breast Implants
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.”
Health breast implants concerns over suspected French spread abroad
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.