Silicone breast implants are not lifetime devices

July 4, 2011

The safety of silicone breast implants was confirmed by the FDA, but studies suffer due to a high dropout rate.
The safety of silicone breast implants was confirmed by the FDA, but studies suffer due to a high dropout rate.

A recent FDA report says, “Recognize that breast implants are not lifetime devices.” Many women with silicone breast implants will need surgery to modify or remove them within a 10-year period because of common complications. This is important information, especially if you’re in your 20s and 30s, the age at which most women get breast implants.

The endurance of silicone implants is different for women who got them for cosmetic enhancement from women who got them following mastectomy. The FDA says 20 to 40 percent of women who got implants for enhancement needed implant removal compared with 40 to 70 percent of women who got implants after mastectomy. Failed implants are covered by the manufacturer’s warranty., June 22nd, 2011, reports that despite frequent complications, the FDA says that silicone implants are relatively safe. Preliminary review of studies found no evidence that silicone implants increase the risk of breast cancer, reproductive abnormalities or other problems. This is good news for the many women who prefer silicone implants to saline because of the more natural look and feel of silicone.

The studies generating this information were performed by Mentor and Allergan (breast implant manufacturers). Silicone implants, pulled off the market in 1992 were returned to the market in 2006, but their approval required manufacturers to conduct large 10-year studies. The FDA report on June 22nd is the first glimpse at results. Unfortunately, women in the study had a high dropout rate, so results cannot be considered conclusive. While the reason for dropout is unknown, it is possible that dropout patients are having no symptoms.

According to the FDA, Mentor has three-year data for only one out of five women while Allergan has two-year data for three out of every five. The FDA is working with these companies to improve participation.

Dr. Jeffrey Shuren, director of the FDA’s center for medical health, advises women with implants to seek regular checkups and pay attention to any changes or symptoms in breasts that have an implant.

With follow-up care so important, if you’re considering implants, make sure you will have ongoing access to your plastic surgeon. The FDA has not said its last word on silicone implants. A board-certified plastic surgeon from the American Society for Aesthetic Plastic Surgery will help you make an informed choice. 

The mission of the American Society for Aesthetic Plastic Surgery (ASAPS) includes medical education, public education and patient advocacy. Plastic Surgery News Briefs are summaries of current stories found through various news and magazine outlets that relate to or mention plastic surgery and cosmetic procedures. The views expressed in these news articles do not necessarily reflect the opinions of ASAPS, but are merely published as an educational service to our members and the general public. For additional information on these subjects and other plastic surgery related topics, please go to

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The American Society for Aesthetic Plastic Surgery (ASAPS), is recognized as the world's leading organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body. ASAPS is comprised of over 2,600 Plastic Surgeons; Active Members are certified by the American Board of Plastic Surgery (USA) or by the Royal College of Physicians and Surgeons of Canada and have extensive training in the complete spectrum of surgical and nonsurgical aesthetic procedures. International Active Members are certified by equivalent boards of their respective countries. All members worldwide adhere to a strict Code of Ethics and must meet stringent membership requirements.


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