Two years ago, reports of defective silicone breast implants manufactured by PIP (Poly Implant Prothèse) prompted authorities to halt production of the devices.
The breast implants are said to have a very high failure rate and a non-medical type of silicone gel. France is now encouraging women with these implants to have them removed.
PIP silicone gel-filled implants have never been approved for use in the United States. The only way an American patient would have these implants is if she had undergone breast surgery in another country.
ASPS Monitoring the Situation
The American Society of Plastic Surgeons (ASPS), working with the French Society of Plastic Reconstructive and Aesthetic Surgery, is monitoring the recent developments on PIP silicone gel breast implants.
The ASPS issued a statement to its members practicing outside the United States:
“We believe that while the current focus of attention is in France, approximately 80 percent of PIP implants were exported to other countries including the United Kingdom, Spain, Brazil, Argentina, Chile, Colombia and Venezuela. There are also reports that implants under the brand name “M,” distributed by a Dutch company in Germany – and possibly elsewhere in Europe – may also be PIP implants that were rebranded as “M” implants.”
According to Reuters, Italy is working with cosmetic surgery clinics to compile a list of women who received the implants. Meanwhile, officials in Brazil and Britain are urging women to check in with their surgeons. The French government is recommending and offering to pay for explantation surgery – if the original surgery was for breast reconstruction.
Allergan Inc, American Breast Implant Maker Assures Quality of Their Implants
In response to the French situation, Allergan issued a lengthy press release to reassure surgeons and patients about the quality of their breast implants. Allergan’s products are marketed under the names Natrelle, McGhan and CUI. None of these implants are included in the French investigation.
“The health authorities are specifically concerned about breast implants made by the company called Poly Implant Prosthese (PIP),” states the Allergan Press Release. The release also describes the extensive checks that are in place to ensure quality of their implants. “Allergan maintains rigorous clinical development processes, extensive manufacturing and quality assurance testing, as well as an industry-leading post-marketing surveillance program, to ensure the highest quality and safety of its breast implants that patients and surgeons can rely on.”
AP Video: France Calls for Breast Implant Removal
The following video from Associated Press briefly explains the situation.