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FDA Releases Update on Silicone Gel Breast Implants

womanAgency stands by 2006 approval after review of follow-up studies

When silicone gel-filled breast implants were approved for general use in 2006, the two breast implant manufacturers were required to conduct ongoing follow-up studies on their safety. Five years later, the FDA’s first major review of the manufacturer studies finds that silicone breast implants are safe and effective when used as intended. The report also said there is no evidence of these implants causing breast cancer or other major health problems, though women should fully understand the risks.

After a 14-year hiatus, Silicone Gel-Filled Breast Implants were approved by the FDA in Nov. 2006 for breast augmentation in women over the age 22 and for breast reconstruction. As a condition of this approval, the FDA required breast implants makers Allergan and Mentor to conduct studies to assess their long-term safety and performance.

The preliminary data reviewed by the FDA does not indicate that silicone breast implants cause breast cancer, reproductive problems or connective tissue disease, such as rheumatoid arthritis, though the report said more research is needed.

The report said the most common complication with breast implants continues to be capsular contracture, or hardening of the area around the implant. Other possible complications include rupture, wrinkling, asymmetry, scarring, pain and infection. The FDA observed that breast implants are not lifetime devices and that one in five recipients of silicone breast implants for breast augmentation will need to have them removed within 10 years.

Breast augmentation was the most popular cosmetic surgical procedure in the U.S. last year with more than 300,000 surgeries using silicone gel or saline breast implants.

Breast Augmentation, Lift, Reconstruction

Breast Enhancement Birmingham, Alabama

If you are considering Breast Augmentation, Breast Lift or Breast Reconstruction, please call 205-980-1744 or contact our Plastic Surgeons online to ask about a consultation with the Board Certified Plastic Surgeon William Hedden MD at our Alabama Plastic Surgery center in Birmingham.

At your consultation, experienced surgeonĀ Dr. William J. Hedden will fully address your questions, discuss your options in saline or silicone gel breast implants and help you decide if breast enhancement is right for you and your aesthetic goals.

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