A breast implant scandal in Europe has drawn the attention of women throughout the world, including here in the United States. Poly Implant Prothese (P.I.P.), a French breast implant company was shut down in April 2010 after it was revealed that the manufacturer was using sub-standard, industrial grade, silicone in its’ gel prostheses. In January 2012 the former head of the company and other principals were arrested in France and charged with involuntary injury.
The P.I.P. implants were also found to have a significantly high rupture rate. The combination of rupture and non-medical grade silicone are of concern because of the risk of severe inflammatory reaction within the breast. European health authorities have recommended that women with these implants have them removed.
P.I.P. has sold over 300,000 implants in 65 countries throughout the world. Most of the implants were exported. Latin American countries were among the largest purchasers of these defective implants. Central America, Mexico, Argentina, Venezuela, Colombia and others have used the French implants since the early 1990s. Brazilian plastic surgeons purchased 25,000 P.I.P. implants.
The U.S. has very strict standards for the sale of breast implants. Currently only two manufacturers, Mentor/J&J and Inamed/Allergan, have F.D.A. approval for the sale of breast implants here. However, the landscape in Latin America is very different. In excess of 10 breast implant manufacturers, from countries such as China, Brazil and France, offer their products for sale there.
The American French Connection
Although only the two U.S. manufacturers are permitted by the F.D.A. to sell implants in the U.S., French implants have appeared in South Florida because of the number of patients who travel to Central and South America for breast augmentation.
Typically these women travel to cities in Venezuela, Colombia, the Dominican Republic, Costa Rica, and others seeking implant surgery at a lower cost. Often the cost savings is in the implants themselves, since the U.S. implants can cost up to $1,000. each. French, Chinese and Brazilian implants typically cost hundreds of dollars less.
Most recently, health authorities from several countries in Latin America have recommended that women with P.I.P. implants return for consultation with their plastic surgeon. It is also advisable that patients planning surgery outside the U.S. obtain detailed information about their prostheses, as well as the plastic surgeon and the surgical facility.
Jorge A. Perez, M.D., F.A.C.S. is a member of the NOVO, National Council of Leaders in Breast Aesthetics. He has served as a consultant for Mentor (J&J) and Inamed (Allergan), both leading U.S. breast implant manufacturers. He has lectured internationally to plastic surgeons on the subject of breast surgery and has been selected among Castle Connolly’s (U.S. News & World Report) list of America’s Top Doctors. More information is available athttp://www.perezplasticsurgery.com or call (954) 351-2200.