According to the American Society of Plastic Surgeons, breast augmentation is the top cosmetic surgical procedure. And approximately 50 percent of patients who underwent breast augmentation opted for silicone gel-filled implants.
Silicone gel-filled breast implant history:
Silicone gel-filled breast implants were first introduced to the U.S. in 1962; considered a moderate risk or Class II product in 1976 by the U.S. Food and Drug Administration, FDA; and in the early ’80s, due to concerns about the safety of silicone gel-filled implants, the FDA reclassified breast implants into a Class III—higher risk product.
Following a 1992 review of public concerns about certain complications such as implant rupture and silicone leakage, the FDA removed all silicone gel-filled breast implants from the market and required manufacturers to submit premarket approval applications that contained data on safety and effectiveness. However, the FDA did allow the use of silicone gel-filled implants for reconstruction after mastectomy, correction of congenital deformities, or replacement of existing implants. Studies were conducted on these women and data collected about device performance and safety.
In 2006, the FDA determined that the benefits and risks of breast implants were sufficiently well understood for women to make informed decisions about their use despite frequent complications and adverse outcomes derived from manufacturers’ clinical studies.
The FDA’s recommendations for patients who are considering a silicone gel-filled breast implant:
- The longer the devices remain implanted, the more likely you are to experience a complication
- Complications include capsular contracture, reoperation, removal, and implant rupture
- Adverse outcomes may include breast pain, wrinkling, asymmetry, scarring, and infection
- Frequent follow-up visits with your doctor is advised and include MRI exams to detect “silent rupture” of the implant
- Be on the look out for unusual signs and symptoms such as pain, asymmetry, hardness or swelling
- Continue routine screening mammography for breast cancer at intervals recommended by your doctor based on your age and risk factors
In summary, the FDA believes that silicone gel-filled breast implants “have a reasonable assurance of safety and effectiveness when used as labeled.”
According to its website, the University of Michigan Health System Department of Surgery reports many plastic surgeons believe that silicone gel-filled breast implants have a more natural look and feel compared with saline implants. They also, however, indicate its disadvantages and health risks. Please visit their website for more information.
FDA’s new June 2011 website on Breast Implants
Breast Implant Complications Booklet
American Society of Plastic Surgeons
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