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Angelo Cuzalina, MD

FDA Releases New White Paper on Silicone Gel Implants

implant safety of silicone gelThe U.S. Food and Drug Administration has released a new white paper about silicone implant safety.

Now on the FDA website, you can download the full white paper or read the executive summary and learn about 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.

  • According to the FDA, “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.” Although routine breast implant replacement is not considered necessary, a revision is often needed 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.






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