Breast implants are used to enhance breast size and shape.
The Food and Drug Administration's mission is to approve products that are safe for consumers, including medical prosthetics and implants. The FDA defines breast implants as "medical devices that are implanted either under breast tissue or under the chest muscle for breast augmentation or reconstruction." There are two major types of implants: saline-filled and silicone gel-filled.
Saline Implants
Saline breast implants were approved by the FDA in May 2002. As of May 2010, hey are approved only for breast augmentation in women over the age of 18. In women requiring breast reconstruction, saline implants may be used at any age. The implants are made from a silicone shell but are filled with saline, or saltwater, solution.
Silicone Implants
Silicone implants were approved for use in women over age 22 in November 2006. As with saline, the FDA also does not require an age restriction in reconstructive surgery cases. The FDA requires a higher age restriction in cosmetic cases because of the necessity of magnetic resonance imaging to detect silent ruptures in silicone implants. A ruptured saline implant will deflate, and the body will absorb the solution. A silicone implant may leak silicone into the tissue surrounding a rupture site, and this can be detected only by advanced imaging.
Clinical Studies
As of May 2010, the FDA is conducting studies of manufacturers other than Mentor and Allegran as well as research into cohesive silicone gel-filled implants. These devices are permitted to be used only in these studies and are not approved to be marketed. Women who wish to receive these implants must contact a Breast Implant Resource Group to find a participating physician. These implants will continue to be studied after approval.
FDA Position on Platinum
The FDA has extensively studied literature on the use of platinum metal in the production of implant shells and gel. They have also studied biocompatibility and testing of gel leaks.The FDA's position is that the amount of platinum is in a state that poses the lowest potential health problems, known as zero oxidation. This information is continually studied.
Post-Approval Studies
Even after receiving approval, the FDA can can require manufacturers to make changes. Product labels may be changed, or patients, who are required to be registered with their manufacturers, may be contacted to inform them of new information. Women who receive breast implants are given a card bearing the serial number and lot of their implant, so they may also look up information regarding a particular implant they may have.
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