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Silicon Breast Implants Improved But Still Come with Risks, Says FDA



The U.S. Food and Drug Administration recently released further studies about the safety of silicone gel breast implants. Silicone breast implants have been around since the 1960s and are used to alter the size and form of women's breasts. In the 1990s the federal government instituted class action lawsuits against the manufacturers of these devices due to ruptures and leakage of the silicone material contained in the implants. Concerns were also raised about potential increased cancer risks.

Manufacturers Allowed to Reintroduce Silicone Breast Implants

Manufacturers Johnson & Johnson and Allergan were allowed to reintroduce silicone breast implants in 2006, provided they undertook continuing research with patients who received the implants to determine the long-term performance and safety of the product. The research, which included more than 1,700 patients, revealed no evidence of connective tissue disease, reproductive problems, or breast cancer. The report did note that the companies experienced difficulty getting patients to cooperate in postsurgery monitoring and that rare complications from the silicone breast implants may not have been revealed during the study. MRI studies remain the best way to determine whether a breast implant has ruptured and is leaking.

FDA Noted Implants Pose Problems

However, the FDA noted that the implants do pose problems that women should be aware of before opting for this type of procedure. The FDA found that the longer a woman has breast implants, the more likely she will need to have them removed. The studies showed that 20 to 40 percent of silicone implants used for breast augmentation and 40 to 70 percent of implants used for breast reconstruction required further surgery within eight to ten years of the original surgery. Breast implant recipients must continue to monitor themselves for local complications for the rest of their lives. The FDA also found that implant recipients may have a very small but increased likelihood of anaplastic large cell lymphoma, which is a rare form of blood cancer. The FDA concluded that while silicone breast implants have a reasonable assurance of safety and effectiveness when used as directed, they are not lifetime devices and are likely to require removal or replacement. All users of these devices should continue to receive periodic MRI exams to ensure that no rupture of the implant has occurred.