French breast augmentation developer Poly Implant Prothese (PIP) produced an average of 100,000 silicone implants per year and sold them to cosmetic surgical groups all over the world. Their popularity came in part because they were among the cheapest manufacturers of their kind and, consequently, their subsequent downfall came as a result of the very marketing ploy they used to sell so many. PIP’s implants were cheaper than their competitors’
PIP grew rapidly in the ‘90’s under the direction of founder Jean-Claude Mas, who by all accounts is an amazing salesman and, before the recent scandal caused his company to collapse, was being touted as one of France’s success stories. There were already ripples present in PIP’s business when, in 2000, the United States’ Federal Drug Administration put a moratorium on all silicon implants. Once the executives at PIP realized they were free of having to adhere to strict US health regulations, they decided to begin manufacturing their implants with the cheaper grade of silicone. While regulatory filings as early as 2003 revealed serious concerns about the company’s practices as early as 2003, PIP continued to market and sell their product to hundreds of medical practices in Europe, Latin America, and Asia until a series of lawsuits in France finally forced the company to shut its doors .
Even with the American market having been shut to PIP, research shows that their output of, on average, 100,000 units manufactured and sold per year went uninterrupted until late last year. A study published by the National Health Service in the UK indicates that 300,000 implants have been sold in 65 countries since PIP downgraded their standards on silicone. Of those 300,000 units sold, it’s estimated that anywhere from 5%-8% of these implants have been directly attributed to harming the women who’ve had them done.
“The problem that we see with PIP implants is the rupture of the implants. If you are not sure which implants you have, contact your surgeon immediately to find out, and if there are signs of rupture inside the implants, you should see your doctor right away,” warned Dr. Sompob Sansiri.
PIP was the third-largest manufacturer of silicone implants in the world, and they manufactured these implants with unsafe silicone. Industrial-grade silicone is meant for mattresses. Medical-grade silicone is meant for bodies. They operated with impunity for most of the last decade, knowingly risking thousands of women’s health and hundreds of physician’s reputations and practices over that period of time. PIP itself has folded and its founder and former CEO, Jean-Claude Mas, is currently under investigation in France pending a criminal investigation for endangering the lives of thousands of women across the globe.
Mas and PIP might well have been put out of business, but that’s not to say that other companies are necessarily above such egregious ethical breaches.
While breast augmentation is almost always elective and is, by definition, a cosmetic procedure, that doesn’t mean that its practice holds any lower risks for prospective patients or that it alleviates attending physicians from their responsibility to practice medicine safely and ethically. Therefore, if you have had breast augmentation surgery done in the last decade, it’s recommended that you consult your plastic surgeon about the manufacturer of your implant. (This applied both to silicon and saline implants, as the casing for saline implants is typically silicone as well.)
“If you are currently considering a breast augmentation procedure, please ensure that the physician you choose to do this procedure is accredited and that whoever manufactures your implants are clear of ethics violations in yours or any other country, ” added Dr. Sompob Sansiri.
Much of PIP’s success derived from the relative cheapness of their product, which created a cyclical and destructive relationship among plastic surgeons and their patients. Everyone likes the idea of having procedures done at affordable costs, but those affordable costs are totally imaginary if they’re made available by virtue of ineffective, unethical, and/or dangerous practices by manufacturers or medical practitioners.
The desire to be beautiful is never to be confused with the need to be safe. When considering procedures like breast augmentation, liposuction, or any invasive elective procedure, take care to research risks of those procedures as well as their advantages and make sure to ask your potential physicians any questions you might have.
“We encourage patients to choose implants from the United States, which are safer because they meet medical grade standards. That is why we always use breast implants from the United States that are approved by the FDA,” said Dr. Sompob Sansiri.
“We have many patients who want breast implants, and they feel safer when we tell them that our breast implants are FDA approved and from the United States. You should ask your surgeon about the implants. If the surgeon used implants that do not meet medical standards, you should find a new surgeon right away,” added Dr. Sompob Sansiri.
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