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FDA Issues Update on Breast Implant Safety

Jun 23, 2011 | Parker Waichman LLP

Five years after re-approving silicone gel breast implants for augmentation, the U.S. Food & Drug Administration (FDA) is updating the public on the safety issues posed by the devices.  The FDA's update is based on preliminary results of studies that Allergan and Mentor were ordered to conduct in the wake of the 2006 re-approval.  The studies involved some 40,000 women.

According to the FDA, women who receive silicone breast implants should know that there is a good chance that, at some point, the devices will need to be removed or replaced because of complications, including capsular contracture, implant rupture, wrinkling, uneven appearance (asymmetry), scarring, pain, and infection.  Because of these risks, patients with silicone breast implants will need to be monitored with the rest of their lives.

One in 5 patients who received implants for breast augmentation will need them removed within 10 years of implantation. For patients who received implants for breast reconstruction, as many as 1 in 2 will require removal within 10 years of implantation, the agency said.

The good news is that so far, the studies have provided no evidence linking silicone breast implants with breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis.  However, the agency cautioned that studies conducted so far have been too small to reach definitive conclusions on these issues.

On particularly troubling risk faced by recipients of both silicone and saline implants is the small possibility that they will develop a rare type of lymphoma - anaplastic large cell lymphoma or ALCL – near their implant.  Earlier this year, the FDA warned that 60 cases of ALCL have been reported among the 5 to 10 million patients with both silicone and saline breast implant.  In contrast, the cancer normally occurs in the breast in only 3 in 100 million women in the general population.

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