• Breast Implants

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When the U.S. Food and Drug Administration (FDA) lifted the ban on silicone breast implants in 2006, it required the manufacturers to conduct safety studies to evaluate the long-term performance of the products. The FDA has released preliminary safety data from these manufacturer follow-up studies. While the FDA continues to support the safety and effectiveness of the devices, it acknowledges that there are still risks involved with silicone implants.

Silicone implants have been approved by the FDA for breast augmentation in women age 22 or older, and for breast reconstruction in all women. Reconstruction may involve breast cancer or other medical conditions. Silicone implants are also approved for revision surgeries, which correct or improve the result of a previous implant surgery. The two companies that currently manufacture silicone gel-filled breast implants are Allergan and Mentor.

In the report, the FDA claims that the studies do not indicate that the implants cause breast cancer, reproductive problems or rheumatoid arthritis. At the same time, the report acknowledges that no study to date has been long enough or large enough to completely rule out these complications. Furthermore, it does acknowledge that there is a small but increased risk of a rare type of cancer called anaplastic large cell lymphoma (ALCL) in women with breast implants.

The top concern regarding the silicone implants is the likelihood of the failure of the implant. One in five recipients needs the implants removed within 10 years. The longer a woman has them, the more likely she is to have complications and need to have the implants removed or replaced. The most frequent complication is tightening in the area around the implant, followed by implant rupture, wrinkling, asymmetry, scarring and infection.

The FDA recommends that women take care to monitor their implants for any unusual signs or symptoms. Follow-up care is necessary, including an MRI after three years, and every two years after that, to detect ruptures.

If you've experienced complications with your implants, contact our breast implant lawyers for legal assistance.