Demand for breast implants is growing steadily, according to the American Society of Plastic Surgeons, and a recommendation by the Food and Drug Administration might change the availability of silicone gel-filled breast implants in the United States.
In 2003, almost 335,000 women had breast augmentation surgeries, spending more than $800,000 -averaging about $3,300 per surgeon or physician's fee, according to the society.
A federal advisory panel voted 7-2 in April to recommend approval of an application to allow silicone-gel implants filed in 2003 by the Mentor Corporation, one of the two leading suppliers of silicone breast implants in the United States. The panel did not recommend approval of implants from another supplier, Inamed Corporation, because it lacked data about long-term effects of the implants.
The two panel recommendations differed because the scientific data supporting each application differed
FDA spokeswoman Julie Zawisza said.
The application still is under review by the FDA.
In the United States, silicone implants are available only to women willing to participate in a continued study, including breast cancer patients who have undergone a mastectomy, patients who need silicone implant replacements and extremely thin people who will not get the desired structure from saline implants, said Dr. Bryan Michelow, an assistant clinical professor of plastic surgery at Case Western Reserve University.
Most women choose saline breast implants because for the average person, silicone implants have not been available.
Sheryl Hummer, 46, of Columbus, purchased saline breast implants three years ago because she shrank from a C-cup to an A-cup after nursing her children. She opted out of participating in an FDA-approved study to receive silicone implants because she was concerned about the possible risk factors.
The preference toward silicone is because it feels more natural, he said. Saline is firmer and heavier.
Concerns about silicone implants arose when women who had the implants experienced certain symptoms such as fatigue. In 1992, the FDA restricted the use of silicone implants until more research could be done.
During the past decade, independent studies have shown no significant danger in using silicone implants, Michelow said.
Breast implants do not last a lifetime; some may deflate or rupture within the first few months after surgery, while others might take 10 or more years, according to an independent review by the Institute of Medicine in 1999 that can be accessed on the FDA Web site (www.fda.gov). There are other potential complications to getting breast implants, but no evidence that they cause major diseases.
In countries where silicone is available, patients will choose it 90 percent of the time, according the American Society of Plastic Surgeons.
The FDA in America is very strict and they do a good job of protecting people from harmful products but often they cause a lag in allowing things on the market
Michelow said.
Many interest groups, including the National Organization for Women, did not support the FDA decision, claiming that no studies provided enough data to prove silicone implants safe.
More than 1 million women in more than 50 countries have received Mentor Corp.'s gel implants, according to the corporation.
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Ellie Behling
