Silicone Breast Implant Problems Don’t Include Cancer: FDA

Federal regulators have issued new safety data for silicone breast implants, finding no link between the breast implants and breast cancer, but also warning that they are not without a potential risk of serious problems and complications. 

The FDA released a report on June 22 for silicone gel-filled breast implants, which finds that, despite some silicone breast implant problems, the implants are safe and effective when used properly.

The newly-released report includes the preliminary data from manufacturer studies, as well as safety information from other researchers and adverse event reports submitted to the FDA. The review is ongoing and FDA officials said they would release more data as it becomes available. 

A silicone breast implant recall was issued in 1992 because manufacturers had failed to provide the FDA with necessary medical data showing that the implants were safe and effective. There were concerns at the time of possible breast cancer links, but studies did not find a connection and silicone implants were returned to the market in 2006.

The FDA has issued several warnings to consumers regarding silicone breast implant side effects. In January, the FDA also warned that both silicone and saline breast implants may be linked to a form of cancer known as anaplastic large cell lymphoma (ALCL). While it can form in the breasts, it is not considered breast cancer.

Women who are considering receiving silicone gel-filled breast implants should be aware that they are not lifetime devices and that the longer they had them, the more likely they were to suffer complications, according to the FDA.

According to the federal regulatory agency, potential silicone breast implant problems could include: 

• Capsular contracture; a tightening of the area around the implant
• Implant rupture
• Wrinkling
• Asymmetrical appearance
• Scarring
• Pain
• Infection

These silicone breast implant side effects could lead to additional surgeries or require implant removal. The agency said it is continuing to work with the two domestic makers of breast implants, Allergan, and Mentor Corp., a subsidiary of Johnson & Johnson, to collect follow-up data on women who have received the implants.

The manufacturers report that they have had problems keeping women enrolled in silicone breast implant studies. Jeffrey Shuren, the director of the FDA’s Center for Devices and Radiological Health, urged women who have enrolled in breast implant clinical studies to continue to participate so that the long-term performance of breast implants can be better understood. 

The FDA advised women and their health care providers follow up routinely on breast implants, using magnetic resonance imaging (MRIs) to look for silent implant ruptures that the woman may be unaware of, be aware that breast implants are not meant to be lifetime devices, and pay attention to unusual breast implant problems and symptoms and report those issues to the manufacturer and Medwatch, the FDA’s adverse event reporting program.