France Recall of Poly Implant Prothese (PIP) March 2010

In March of 2010, France’s health authorities pulled a French made silicone breast implant off the market. This was reported by MSNBC in “France Recalls Type of Breast Implant” but not widely covered in the US or on the Internet. The Poly Implant Prothese (PIP) was pulled following a reported increase of pre-filled silicone rupturing. The subject breast implants were recalled and women were advised to visit with their surgeons yearly and undergo ultrasounds annually.

Breast Implant Recalls

There are no recent recalls relating to Breast Implants. However, given that they are man made products, put through a manufacturing process prior to implantation, it is not unreasonable to expect future recalls or information relating to additional post marketing surveillance of breast implants. Critics of the FDA’s recent announcements, during June 2011, that relied upon information provided by current manufacturers have voiced concern over the data and length of studies cited. Breast Implants have had a stormy history with the American public and civil justice system. As a result, we will continue to monitor and report on any news, recalls or announcements relating to Breast Implants, their safety or possible recalls.

FDA Warns Silicone Implants Fail with Time

While controversial, Breast Implants continue to serve a variety of purposes in modern society. Breast Implants have been available to consumers, through plastic surgeons for a number of decades. There are generally two types of breast implants: (a) saline and (b) silicone. The types are discussed below in a separate post.

Regardless of the type, the FDA announced on June 22, 2011, that “Breast Implants are not lifetime devices.” In fact, “the longer a women has silicone-filled breast implants, the more likely she is to experience complications.” A recent NPR posting, by Nancy Shute, “FDA Finds Silicone Breast Implants Safe, But Prone to Fail with Age”, Dr. Jeffrey Shuren, head of the FDA’s device division includes these exact quotes.

The FDA has also posted information relating to all Breast Implants and related procedures at their website under Products and Medical Procedures, Implants & Prosthetics - Breast Implants.

A link to the FDA’s * on Breast Implants can also be accessed through this link:

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/default.htm