December 10, 2013
Caroline Glicksman, MD
Peter B. Fodor, MD, FACS
with Carolynn Grimes
Jean-Claude Goes to Jail
Jean-Claude Mas, founder and long-time chief executive of Poly Implant Prothese (PIP), has been prosecuted and sentenced to four years in prison. Mas hid the fact that the PIP implant was made with a sub-standard silicone that was used in about 400,000 women around the world. A police investigation revealed that PIP had committed fraud when they managed to conceal the implants’ ingredients from regulators.
German Company Failed in its Obligations
Dr. Caroline Glicksman, a board certified plastic surgeon and an expert in U.S. breast implants says the German quality control company, TUeV Rheinland, that provided the implants EU (European Union) certification may have “rubber-stamped” the faulty PIP implants and failed to inspect the facilities where the implants were manufactured. TUeV Rheinland was recently ordered to compensate hundreds of women who received the implants.
“It makes one wonder how a breast implant manufacturer in France was able to substitute industrial grade silicone for medical grade silicone for years, and still receive EU safety certification. Although many of us were frustrated by how slow our FDA was to approve the newest highly cohesive gel breast implants in the United States, (over 12 years), at least we can be assured that breast implants are safe and effective for American women,” says Glicksman.
“It is very unfortunate that some manufacturers do not follow all safety measures to protect patients who end up being exposed to their products,” says Dr. Peter Fodor, a board certified and an internationally recognized aesthetic plastic surgeon. “While we often have a tendency to criticize the FDA (Food and Drug Administration) as being too stringent with their standards, when we become aware of violations such as this, we need to remember that the FDA goes a long way in protecting U.S. consumers when compared to the scrutiny that organizations fulfilling the role of the FDA in other countries exercise.”
PIP Implants Never Sold in U.S.
PIP was once the third-largest global supplier of breast implants before it was shut down in 2010 and its implants ordered off the market. Fortunately, says Glicksman, they were never sold here in the U.S., and very few American women have them. According to recent reports from Reuters, only one case of anaplastic large cell lymphoma, a rare type of cancer originating in the lymphatic system, has been documented in France from women having the PIP implants.
Worried about the effect the implants could have on their body, it’s been reported that 13,500 Frenchwomen have undergone surgery to remove the implants.