FDA deems silicone breast implants to be safe

The FDA has released a report confirming that silicone gel-filled breast implants are safe and effective when used as intended. However, women should fully understand the risks prior to considering these implants for breast augmentation or reconstruction.

As the Los Angeles Times notes, it was five years ago that the FDA allowed silicone breast implants back on the market after a 14-year hiatus that had resulted from fears of adverse events. The agency got some heat for this decision, but the studies seemingly show the decision was sound.  

"I don't know what the critics will ultimately say," said CDRH Director Jeffrey Shuren, as quoted by the LA Times, "but what we can say is the current data doesn't indicate that silicone-gel-filled breast implants are linked to breast cancer or connective tissue disease or infertility."

The report includes preliminary safety data from post-approval studies conducted by Allergan and Mentor, which were required to perform six post-approval studies to characterize the long-term performance and safety of the devices as a condition of their approval. The FDA approved silicone gel-filled breast implants in November 2006 for breast augmentation in women over the age of 22 and for breast reconstruction in all women.   

In its report, the FDA notes that breast implants are not lifetime devices. And the longer a woman has these implants, the more likely she is to experience complications. In fact, one in five patients who receive implants for breast augmentation will need to have them removed within 10 years of implantation. And for those who received implants for breast reconstruction, as many as one in two will require removal 10 years after implantation, according to a statement from the agency.

Preliminary data do not indicate that the implants cause breast cancer, reproductive problems or connective tissue disease, such as rheumatoid arthritis. However, in order to rule out these and other rare complications, longer and larger studies would need to be conducted. The FDA will hold an expert advisory panel in the next few months to discuss how post-approval studies on breast implants can be more effective.

The agency advises women to follow up with their healthcare professional and get routine MRIs to detect silent rupture. Women should also pay attention to changes and notify their doctors if they develop any unusual symptoms.

- see the FDA's release
- get more from the LA Times