Are Silicone Breast Implants Safe?

Posted September 21, 2015

Silicone Breast Implant Safety

Are Silicone Breast Implants Safe?When considering a breast augmentation or breast reconstruction many patients are concerned about the safety of silicone-gel breast implants. In 1992 the FDA banned silicone implants for breast augmentation for 14 years based on the fact that there weren’t any long-term studies to prove their safety. Meanwhile, only saline (or saltwater) implants were available for cosmetic breast implantation. Here are some facts about silicone-gel breast implants:

  • They are the single most researched devices by the FDA.
  • Studies have shown that there is no link between silicone implants and disease.
  • Studies are still continuing today, like Breast Implant Follow-Up Studies (BIFS).
  • The FDA advises the patient to be 22 years or older before getting silicone implants.
  • The look and feel is much more comparable to a natural breast.
  • Implants do not last a lifetime, with any medical device there is a failure rate.
  • 77% of implants must be replaced or fixed after 10 years.
  • They are less likely to leak now that they are made of cohesive gel silicone.
  • Dr. Doezie is 100% confident in using silicone implants on his patients.

Two of the main silicone implant manufacturers, Allergan and Mentor, conducted studies to provide data for adequate safety and effectiveness. In November 2006, based on their studies, the FDA approved Allergan and Mentor’s silicone gel-filled breast implants for breast augmentation and continuing breast reconstruction. One condition of approving silicone implants was that each company needed to continue doing studies and collect information.

Some writings by the scientific community have speculated a possible association between anaplastic large cell lymphoma (ALCL) and silicone or saline-filled breast implants. In January 2011 the FDA issued a safety communication for women with breast implants and the possibility of ALCL, which is a rare non-Hodgkin lymphoma, and is even more rare in the breast area.

  • The FDA is only aware of about 60 cases of ALCL in women with breast implants worldwide.
  • About 3 in 100 million women per year are diagnosed with ALCL in their actual breast.
  • About 1 in 500,000 women are diagnosed with ALCL in the U.S. each year.

Because there is not a definite link with ALCL and breast implants, the FDA currently recommends that implants are safe and effective when used as labeled. The look and feel of silicone breast implants are far more desirable than saline implants, and both implants are safe for cosmetic and reconstructive use.

Allen Doezie, M.D., is a board certified plastic surgeon with over 10 years of experience. His office is located in Orange County, California. To schedule a consultation, please call 949-481-9850.

Citations

Silicone Implant Ban Lifted. (n.d.). Retrieved September 12, 2015, from http://www.plasticsurgery.org/articles-and-videos/video-gallery/silicone-implant-ban-lifted.html

U.S. Food and Drug Administration. (2013, September 25). Retrieved September 12, 2015, from http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm064461.htm

U.S. Food and Drug Administration. (2011). Retrieved September 14, 2015, from http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239996.htm#overview