FDA Approves Two Types of Breast Implants

The Food and Drug Administration announced Friday that it had approved two types of silicone gel breast implants, after decades of debate over their safety. The FDA's Dr. Daniel Schultz said manufacturers must gather detailed information on 40,000 implant patients over the next 10 years.

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The Food and Drug Administration has approved the use of two types of silicone gel breast implants after decades of debate over safety issues. Until now, the implants have been limited to women were undergoing breast reconstruction, and those women have had to enter a study to get them. Soon they'll have free access to the implants and women who want them for cosmetic reasons will be able to get them too. NPR's Richard Knox reports.

RICHARD KNOX: The FDA announced the decision at 5:30 on a Friday evening, not uncommon for controversial issues. Officials say they have sifted through mountains of evidence and decided that silicone breast implants are probably safe. There are just two restrictions. Women who want silicone implants for cosmetic reasons must be at least 22 years old. And the FDA's Dr. Daniel Schultz says manufacturers must gather detailed information on 40,000 implant patients over the next 10 years.

Dr. DANIEL SCHULTZ (Food and Drug Administration): The information will be collected about the rates of local complications, including rupture, rates of connective tissue diseases and its signs and symptoms, rates of neurological diseases and its signs and symptoms, potential effects on offspring of women with breast implants.

KNOX: And that's not all. The FDA is instructing the companies to monitor women for any effects on reproduction, breast feeding, for any incidence of cancer, for the implant's possible interference with mammography, even for suicides. And the FDA says women should get periodic MRI scans for the rest of their lives to see if their implants have ruptured. Schultz says ruptures are almost inevitable.

Dr. SCHULTZ: Women having these procedures done need to be prepared for the fact that there is likelihood that they will require additional surgery.

KNOX: Few things have caused as much emotional back and forth as silicone breast implants. That's partly because the first models in the 1970s and '80s did cause problems. They broke, the silicone seeped into other areas of the body, there was scar tissue. Some women claimed that faulty implants caused immune disorders and cancer. Scott Spear, a plastic surgeon in Washington, D.C., says he understands why silicone implants got a bad rep.

Dr. SCOTT SPEAR (Plastic Surgeon): There were people who had damages from the earlier devices because there was no real controls in terms of how they were made or how they were tested. In fact, they weren't tested.

KNOX: In 1992, the FDA said it wanted more evidence before approving silicone implants. Since then, many women have gotten implants filled with salt water, which avoids the alleged problems with silicone but isn't as lifelike. Spears says he's sure the newer models are safe, and not just because he's a consultant to Allergan, one of the implant makers.

Dr. SPEAR: I can tell you with absolute confidence that the medical issues really have been put to rest as much as they could be for any drug or device.

KNOX: But Sybil Nyden Goldridge(ph) isn't convinced. She had bad experiences with some of those earlier implants after cancer surgery in the early 1980s. That made her into a diehard opponent of silicone implants through the twists and turns of the long regulatory process.

Ms. SYBIL NYDEN GOLDRIDGE (Cancer Patient): It sure has been a roller coaster and it's not over. The manufacturers will not hold to what they said because they never have before. The bottom line is, the FDA has no strength.

KNOX: So Goldridge says she and other patient advocates will be watching to make sure women who get silicone breast implants really are monitored closely. Richard Knox, NPR News.

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