FDA Updates Stance on Silicone Implant Safety

The U.S. Food and Drug Administration has released a new white paper about silicone implant safety. Now available on the FDA website, you can download the full white paper or the executive summary and read findings from the latest research.

For patients and consumers, the most pertinent aspects of the document include the “Summary of key findings” and the “Recommendations for Patients Who Have or Who Are Considering Breast Implants.”

Some of the silicone implant safety findings are as follows:

• When used as labeled, silicone implants “have a reasonable assurance of safety and effectiveness.”
• No association has become evident between silicone implants and connective tissue disease, breast cancer, or reproductive problems.
• An MRI is still the recommended method for detecting silicone implant ruptures.
• The longer you have silicone implants (or saline implants), the more likely it is that you will experience a complication or adverse outcome. Choosing breast augmentation or implant-based breast reconstruction means monitoring your implants for a lifetime. “Between 20 to 40 percent of augmentation patients and 40 to 70 percent of reconstruction patients had reoperations during the first 8 to 10 years after they received their implants,” the FDA reports. Although “routine replacement is not necessary,” a revision is necessary for many women.
• Patients who have breast implants have a very small, but increased likelihood of receiving diagnosis of analplastic large cell lymphoma.

The FDA continues to monitor the safety and effectiveness of silicone implants. For updates on the latest findings, visit www.fda.gov/breastimplants.

ASPS Responds to FDA White Paper on Silicone Implant Safety

Today, the American Society of Plastic Surgeons responded to the white paper. An email to member surgeons stated that ASPS

1. Agrees that “silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled,”
2. Accepts the Agency’s position that women who receive silicone gel-filled breast implants for reconstructive or cosmetic purposes will need to monitor the devices over their lifetime.
3. Believes that the FDA white paper is informative and will be a good resource for plastic surgeons and patients
4. Shares the FDA’s view in the white paper that more than 90 percent of patients are satisfied with their outcomes from breast implant surgery.
5. Will continue to collaborate with the FDA to ensure that science forms the basis for all decision-making on breast implants