Are Silicone Gel-Filled Breast Implants Safe?
The FDA has evaluated and approved Natrelle® silicone gel-filled breast implants for Breast Augmentation and Breast Reconstruction based on years of data collected from more than 50,000 women.
Silicone gel-filled breast implants are among the most studied medical devices in history. Decades of research have evaluated their safety and effectiveness. The safety of Natrelle® silicone gel-filled breast implants is supported by extensive pre-clinical testing, US clinical studies and European research. More information about the safety of silicone gel-filled breast implants can be found in the Institute of Medicine report at http://www.breastimplantanswers.com/important_studies.html and http://www.allergan.com/labeling/index.htm
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How Long do Breast Implants Last?
No medical device can be considered to last forever, just as no natural body part necessarily lasts a lifetime. It is possible for any breast implant to leak, and that is true of both the saline and silicone gel filled breast implants. So assume that all implants will eventually wear out, because of the constant repetitive movements of the chest caused by breathing some 15,000 times a day. If every person with a pacemaker, breast implant, heart valve, knee joint etc lived to be 100, it is likely that all of these devices would need to be replaced at some point in their lifetime.
Implants do not have a date when they have to be routinely replaced. But little by little they do wear out. Based upon the best currently available information, many plastic surgeons tell patients to assume that the need for replacement at five-years would be about 1%, by ten years 5%, by fifteen years 25%.
It is not required to just routinely replace older, still intact implants because there is no known danger to you. But the FDA recommends frequent MRI testing for silicone gel implants.
Insertion of a new (same-size) implant is usually done through the original scar, regardless of whether it is in the underarm, nipple, or crease. Breast implant replacement is less involved than putting in the implant in the first place, provided that the same size or smaller implant is being inserted. Putting in larger implants during a revision is a bigger operation than putting in the implants the first time.
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How Will Breast Implants Affect Having a Mammogram?
Tell your mammography technologist before the procedure that you have breast implants. Be sure your mammography exams are interpreted by a radiologist experienced in the evaluation of women with breast implants. It is relatively common to have additional views taken during screening.
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When did Silicone Gel-Filled Breast Implants Become Available?
In 1991, the FDA concluded that silicone gel-filled breast implant safety data submitted by the manufacturers didn't provide adequate information to determine the benefits and risks over an extended period of time. The panel recommended that the devices stay on the market with limited access, until additional safety data was obtained and reviewed. After thoroughly reviewing 10 years of data, the FDA approved silicone gel-filled breast implants in 2006.
Silicone gel breast implants have been available in more than 60 countries for over 25 years, and the safety profile has been followed with over one million women.
You may have additional questions about your Breast Augmentation procedure or breast implants. There are more answers in the
Natrelle® Pre-Consultation Kit and your plastic surgeon can answer any additional questions during your initial consultation. You can find a board certified plastic surgeon in the Natrelle.com Find a Surgeon Directory.
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