Breast implant safety questioned

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Mentor Corporation faced a problem last year when the California-based company prepared to give doctors cohesive gel implant “models” for prospective patients to try on for size.  After trying on these model breast implants, an unsettling slick of silicone oil was often left on the patient’s body.  Mentor, who vies with competitor Inamed for approval of long-banned silicone breast implants, hopes to gain FDA approval for their product in the near future.  Both companies have received conditional approval of their silicone breast implants. 

Last month, a former senior engineer with Mentor told the FDA that he and his colleagues were asked to fix the problem of the silicone oil leakage.  To fix this problem, engineers developed a one-inch less permeable patch which seals the hole left after the breast implant manufacturing process.  However, despite urging from Mentor scientists, the company decided NOT to make these improvements to implants which are destined for patient use in cosmetic or reconstructive breast implant surgeries. 

The engineer, who remains anonymous for protection, wrote a letter to the FDA stating, “I am very concerned about the safety of women using these breast implants if they were to become widely available as an FDA-approved product.”   The engineer also sent a copy of this letter to the Washington Post to inform the public about these concerns.

The FDA’s Center of Devices and Radiological Health says they have received this letter and is taking its contents very seriously. 

This is the first time breast implant manufacturers are coming close to gaining approval of silicone breast implants since the 1992 ban.  Cosmetic use of silicone implants was prohibited in 1992 due to serious concerns about their safety.  One of the biggest concerns at this time was local complications like implant rupture and “bleeding.”  The FDA will have to consider these recent findings of silicone gel “bleeds” in new implants to determine whether or not the agency will permit unrestricted use of silicone implants. 

According to the American Society of Plastic Surgeons, over 254,000 cosmetic breast augmentation surgeries were performed in 2004.  Another 63,000 reconstructive breast surgeries were performed on women following mastectomy. 

 


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