Safety data on Silicone breast implants
The Food and Drug Administration (FDA) issued a report for updating the clinical information for Silicone Breast Implants. This report includes the basic safety data from research conducted by the manufacturers of the breast implant which are included in their approval condition of November 2006.
Repost for Safety data on Silicone breast implants
This report confirms that silicone breast implants are safe for the health, but women should completely understand the risks factors before going for silicone breast implants surgery.
This report includes safety data from post-approval studies by two silicone breast implants manufacturers Allergan and Mentor. FDA approved silicone breast implants in November 2006 for breast augmentation in women over 22 year of age and for breast reconstruction in all ages of women.
Approval of Safety data on Silicone breast implants
In the approval condition of these two manufactures, the FDA required them to conduct six post-approval researches to identify the long-term safety and performance of the silicone breast implants.
These both companies have identified the difficulties to the FDA in following those women who have silicone breast implants. The FDA is working with both of these companies to overcome those challenges and increase participation and follow-up form the women who have silicone breast implants.
“The FDA will continue to monitor and collect safety and performance information on silicone breast implants, but it is important that women with breast implants see their health care providers if they experience any symptoms. Women who have enrolled in studies should continue to participate so that we may better understand the long-term performance of these implants and identify any potential problems.” Said , Jeffrey Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health.
Currently FDA is recommending that the women who have silicone breast implants should do the following:
Follow up with your Silicone breast implants. Women should continue to routinely follow up with their health care professionals. This includes getting routine MRIs to detect silent rupture in your silicone breast implants.
Be aware of your Silicone breast implants. Silicone breast implants are not lifetime devices. Silicone breast implants are associated with significant local complications and outcomes, including capsular contracture, reoperation, removal, and implant rupture. Some women also experience breast pain, wrinkling, asymmetry, scarring and infection.
Pay attention to changes with Silicone breast implants. Women should notify their health care professionals if they develop any unusual symptoms. All serious side effects should be reported to the silicone breast implant manufacturer and Medwatch, the FDA’s safety information and adverse event reporting program. Report by calling 800-332-1088.
Stay in touch. If a woman has enrolled in a manufacturer-sponsored post-approval study, she should continue to participate. These studies are the best way to collect information about the long-term rates of complications.