Ban on Silicone-Gel Breast Implants Could Be Lifted

BY Rachael Myers Lowe, cancerpage.com

(April 14, 2005) - An FDA advisory panel recommended Wednesday that one brand of silicone-gel breast implant be made available to American women. After voting not to lift the 13 year ban on the silicone implants made by Inamed on Tuesday, the panel said the brand made by Mentor Corp. should be offered in the US but only if the company meets some strict requirements including long-term and costly follow-up for patients and making sure women know that their implants could rupture and pose a health threat without them knowig it. Doctors performing silicone-gel implant surgeries would also have to be specially trained. 

Concerns have been raised about the health effects to women whose silicone-gel implants rupture. Studies have failed to demonstrate the adverse health effects claimed by some, such as an increased risk of developing auto-immune disease or rheumatoid arthritis among women whose silicone implants leaked. Implant manufacturers say their new silicone-gel breast implants are less prone to rupture and leakage.

The FDA’s advisory panel decided this week that Inamed needed longer term data to demonstrate the safety of its implants but that the Mentor implants could be made available for breast augmentation.

Mentor officials had argued they had more information about when and why implants break, as well as research showing implants improve self-confidence for women who got them to rebuild breasts after cancer surgery or others who sought bigger breasts for cosmetic reasons.

Currently, silicone-gel breast implants are only available to women in clinical trials seeking reconstructive surgery after breast cancer.

According to the American Society of Plastic Surgeons, more than 264,000 cosmetic implant procedures and nearly 63,000 breast reconstructions were performed in 2004.

The panel"s recommendation must now be approved by the FDA for the 13-year ban on silicone-gel breast implants to be lifted. 

SOURCE:

• cancerpage coverage of FDA hearings.