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Popular PIP French breast implants made of unapproved, non-medical grade materials
Published in Bikya Masr on 06 - 01 - 2012

Over the last two weeks, controversy surrounding the fraudulent practices of the now-banned French breast implant company, Poly Implant Prothèse (PIP), has consumed the minds of affected women as well as health officials in countries that provided them. The prosthetics contained unauthorized materials and had an allegedly high risk of rupture. Although the health risk is currently contested, the scandal highlights widespread poor ethical practices in the health-care field.
PIP was the world's third largest producer of silicone breast implants, until it was revealed that they, in an illegal move to lower prices, used an industrial-grade silicone often used in mattresses, electronics, and computer parts. Medical-grade silicone is only made by two companies, and by switching types PIP was able to charge a fraction of the cost for their prosthetics. Although the company was shut down last year, the product was not recalled.
Last last month, leading cosmetic surgery firm told French ministers privately that the rupture rate for PIP implants could be as high as 8 percent, well outside of the 1-2 percent industry norm, according to the Independent. The New York Times reported that eight women were diagnosed with cancer after their implants ruptured and one died from anaplastic large-cell lymphoma, a rare cancer. The diagnoses have not been attributed wholly to the rupture and release of non-medically approved substances into the body, but the concomitance was enough to raise alarm.
France's director for health, Jean Yves-Grall, said that the state would pay for the removal of the faulty implants for the estimated 30,000 women with PIP prosthetics, and for the replacement of them only in those women who had mastectomies.
Countries that imported large quantities of the implants have begun releasing statements. Qatar, Tunisia, Israel, Brazil, Venezuela, Australia, and England are among those most affected. With the increasing paranoia and fear surrounding the risk of implant-rupture, many women were demanding that their governments do more to provide information and removal services.
After incongruous data on the implants' rupture rate, the Independent Healthcare Advisory Service (IHAS) released figures on Wednesday that show a rupture rate within the accepted industry norm of 1-2 percent, rather than 8 percent. Andrew Lansley, England's health minister, advises all women with PIP implants – more than 40,000 in the UK – to have them removed based on the potential health risk, although the current IHAS data has yet to be assessed. Lansley hopes to give “definitive advice” on removing the fraudulent implants by the end of the week.
Countries including Qatar, Brazil, and Australia have already come out with statements dismissing the imminent health threat.
The tug-of-war between differing statistics and contested health claims reflects poorly on the state of government oversight on cosmetic surgery providers. How this blatant violation of health- and industry-codes passed regulators unnoticed is still unresolved, but laboratory examinations of the implants have revealed that they contained other harmful chemicals. Toxicologist André Picot, who carried out the research commissioned by radio station RTL, likened implanting these into the human body to “near criminal” activity.
Jean-Claude Mas, the 72 year-old CEO of PIP is wanted in Costa Rica for crimes against “life and health,” according to the International Police Agency's website.
Reuters reports that as early as 2000, US Health authorities and the FDA raised concerns about PIP's manufacturing practices – ten years before European regulators forced the company to shut down.
Despite the lack of sufficient cause for concern, to many this scandal exposes warranted suspicions about the cosmetic surgery industry and the quality of subsequent government regulation. Brands will always find ways to maintain competitive profit margins, but when it comes to health-care, cutting corners is a dangerous game. Given the esoteric nature of the field of medicine, the need for closer oversight and regulation is critical, as has been clearly demonstrated by these events.
BM
ShortURL: http://goo.gl/hEoHn
Tags: Breast Implants, Faulty, PIP
Section: Health, Latest News, Women


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