This page can be used as a resource to find FDA information in regards to your specific breast implant, including: recalls, premarket approval applications PMAs , approval orders, summary of safety and effectiveness documents, labeling pamphlets, PMA Supplements, post-approval studies, and more. Breast implants are Class III medical devices as of It has been evidenced in the breast implant illness groups that there is a trend in premarket study enrollment of the patients but little to no follow-up. The post market approval studies have very low follow-up rates and bring up a serious concern to the alleged lack of safety. To read more on FDA medical device regulation and the basic regulatory requirements that manufacturers must comply, click here. Current manufacturers of approved U.
Post-Approval Studies (PAS)
Mentor MemoryGel Silicone - Breast Implant Illness
Saline-filled breast implants contain a silicone outer shell filled with a sterile saltwater saline solution. Some are pre-filled and others are filled during the implant operation. Saline-filled implants come in different sizes and have either smooth or textured shells. The FDA approved saline-filled breast implants for breast augmentation in women age 18 or older and for breast reconstruction in women of any age. They are also used in revision surgeries, which correct or improve the result of an original surgery.
Gummy Bear Breast Implants
In , after rigorous scientific review, the FDA approved the marketing of silicone gel breast implants for reconstruction in women of all ages and breast augmentation in women ages 22 and older. Daniel Schultz, Director for the Center for Devices and Radiological Health, FDA, said that the FDA had reviewed an extensive amount of data from clinical trials of women studied for up to four years, as well as a wealth of other information to determine the benefits and risks of these products. The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices. This information is available in the product labeling and will enable women and their physicians to make informed decisions. Now that silicone implants have been determined to be safe and effective, the FDA will continue to monitor them by requiring each manufacture to conduct a large post-approval study following about 40, women for 10 years after implantation with silicone implants.
Breast implants are medical devices that are implanted under the breast tissue or under the chest muscle to increase augment breast size or to rebuild reconstruct breast tissue after mastectomy or other damage to the breast. They are also used in revision surgeries, which correct or improve the result of an original surgery. There are two types of breast implants approved for sale in the United States: saline-filled and silicone gel-filled. Both types have a silicone outer shell. They vary in size, shell thickness, shell surface texture, and shape contour.