Nov. 17, 2006 - In a dramatic comeback, silicone breast implants today won FDA approval.
Silicone breast implants came on the market in 1962. In 1992, citing safety concerns, the FDA stopped sales of the implants.
Now the FDA says the implants -- officially designated as "medical devices" -- are safe and effective, said Daniel Schultz, MD, director of the FDA's Center for Devices and Radiological Health.
"The key difference is we now have data. In 1992, there was no data. In 2006 there is data that was reviewed extensively by the agency," Schultz said in a news conference.
Today's approval covers silicone breast implants made by two companies: Inamed Corp., now part of Allergan Inc., and Mentor Corp. Allergan is a WebMD sponsor.
The implants are approved for women of all ages who need breast reconstruction. They also are approved for women age 22 and older for breast augmentation.
The FDA says women should consider several factors before deciding to get the implants. The most important factor, Schultz says, is that breast implants are not lifetime devices. Eventually, he said, they must be replaced.
This means that a woman will likely need additional surgeries on her breast at least once over her lifetime, Donna-Bea Tillman, PhD, director of the FDA's Office of Device Evaluation, said at the news conference.
"We are confident the devices can withstand the forces that affect a woman's body for at least 10 years," Tillman said.
The FDA is also warning women to consider other factors:
- Many of the changes to a woman's breast following implantation are irreversible.
- Rupture of a silicone gel-filled breast implant is most often silent, which means that usually neither the woman nor her surgeon will know that her implants have ruptured. Regular MRI screenings will be needed to see if silent rupture has occurred.
- The FDA says a woman should have her first MRI three years after her initial implant surgery and then every two years thereafter.
- The cost of MRI screening over a woman's lifetime may exceed the cost of her initial surgery and may not be covered by medical insurance.
The approval comes with several conditions for the implant makers. Each company is required to conduct a large postapproval study that will enroll 40,000 women for 10 years. Schultz said the FDA will report the results of these studies at five-year intervals -- or sooner, if the need arises.