New Jersey plastic surgeon Dr. Shain Cuber shares his thoughts on French made implants and how the FDA played a vital role.
FOR IMMEDIATE RELEASE
EDISON, NEW JERSEY - While French manufacturing company Poly Implants Prostheses has made headlines since late 2011, it's not the first time they have been called out on their inferior implants.
In 2000, the U.S. Food and Drug Administration required, for the first time, all companies selling implants to submit an application to continue to sell their products in the U.S.
Although PIP had been selling implants in the U.S. since 1996, the FDA found that PIP's implants were more prone to rupturing because they were made from industrial grade silicone. This discovery resulted in the FDA banning PIP implants from being sold in the U.S.
"The FDA's regulation of implants was a long and drawn out process, but the result was safer implants," said Dr. Shain Cuber, a New Jersey plastic surgeon. "Implant laws are not as stringent in Europe as they are in the U.S., which is why these faulty implants were allowed to be used."
PIP implants were put into the chests of 300,000 European and South American women and were smuggled into 65 countries.
An estimated 30,000 women in France have been advised by the French government to remove their PIP implants as a preventive measure, at the state's expense. Of those 30,000 French women, an estimated 1,000 have already encountered a ruptured implant.
"Removing implants is a simple operation," the tummy tuck and breast implant expert said. "It's only when an implant has leaked that we encounter complications. When a leak occurs, the tissue around the rupture becomes inflamed and causes painful lumps and other anomalies in the breast, making it harder to remove."
A handful of American women traveled overseas and received PIP implants because the procedure was more affordable out of the country.
"When electing to have a surgery overseas, people should really do their research," said the breast implants specialist. "The FDA is in place for a reason. They work hard to ensure only safe implants such as Allergan and Mentor are used, as they come with warranties and have good safety records."
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