FDA Approves Silicone Gel Breast Implants
On November 17, 2006 the Food and Drug Administration lifted its 14-year ban on silicone gel breast implants. Noting that there has extensive clinical data, the FDA approved the products of Allergan and Mentor Corporations to be used for breast augmentation in women ages 22 and older as well as in breast reconstruction in women of all ages.
Over the past ten years, numerous independent studies have failed to show any substantive connection between silicone breast implants and connective tissue disorders or cancer. The FDA will continue to monitor silicone gel implants by requiring both companies to study 40,000 women for 10 years after receiving silicone gel breast implants.
As with saline implants, silicone implants can have complications related to the device, such as leakage, infection, or hardening. The decision whether to use saline or silicone implants is one that is best left to the patient and her physician after a thorough review of all available data.
At Plastic Surgery Associates of Santa Rosa, we have been part of the initial silicone gel implant studies since 1998. Our experience mimics that of the advisory panel to the FDA. Namely, we have found silicone implants to be safe and effective in the patients that have chosen to enroll in the study.
With the new availability of gel implants, we take pride in our long relationship with both Mentor Corporation and Allergan (Inamed) Corporation. We are happy to discuss both saline and silicone implants, their benefits and risks and help you make an informed decision as to which device would be best for you as an individual.
Our staff is very knowledgeable and can help answer your questions. Of course, an in-office consultation with one of our plastic surgeons is the best way to find out whether silicone breast implants are the right choice for you.
Call us at (707) 537-2111 to schedule your private consultation.
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