Mar 01 (Reuters) -- With more women than ever seeking bigger, shapelier,
surgically enhanced breast in the United States, the spotlight returns
this week to the possible safety risks patients face when they decide to
A much-publicized controversy over silicone-gel implants in the early 1990s has made them unavailable for most women. But critics say most are unaware that the alternative --saline-filled implants -- has never been formally approved by the government.
"Most people have assumed saline must be safer than silicone gel," said Diana Zuckerman, head of the National Center for Policy Research for Women and Families, which has criticized the US Food and Drug Administration (FDA) for allowing the implants to stay on the market without proof of safety.
"People should be making informed decisions based on objective research information," she told Reuters. The first public scrutiny of saline implants will come this week, when a panel of federal advisers reviews the data at a three-day meeting starting on Wednesday. The panel is expected to vote on whether implants made by three firms meet safety and effectiveness standards and should win formal FDA approval. The FDA has the final say but usually follows its panels' advice.
The agency has permitted the sale of saline implants without official approval because they were on the market before the agency had authority over medical devices. The agency assumed they were safe unless proven otherwise.
Three saline implants makers, Mentor Corp., Poly Implant Prostheses and Inamed Corp.'s McGhan Medical unit, will present data to the panel this week. If any product is deemed unsafe, the FDA could take it off the market.
But most experts do not expect that to happen. They predict the implants will win formal approval and spur even more interest in breast augmentation. "Should they get the actual endorsement, it should be extremely positive for the industry," said Preferred Capital Markets analyst Kate Sharadin.
Silicone implants are currently available only for women with breast cancer who want reconstructive surgery, about 5 percent of all implant patients.
Implant makers and plastic surgeons acknowledge the potential for some complications, including rupturing and infections, with either implant type.
They note, however, that reports have cleared silicone implants of any role in serious, chronic diseases such as cancer or lupus.
Dr. Lin Puckett, head of the American Society of Plastic Surgeons, said physicians try to present a balanced view when they discuss breast augmentation with women. "We're obliged to tell them to deal with all of the alleged complications as well as the known and real complications," Puckett said. Health groups, meanwhile, say dozens of women with saline implants have reported breast pain, implants that turn as hard as rocks and potentially serious bacterial infections. Implants can also require replacement, exposing women to the risks of repeated surgery and loss of their own breast tissue.
Other women, some of whom will testify before the FDA panel, say their saline implants caused autoimmune diseases that destroyed their health. "Everything that has been reported with silicone gel implants has been reported with saline implants," Zuckerman said. "What's not clear is how often that happens."
The new attention comes when the breast implant business is booming. About 150,000 women received implants last year, an increase from the 125,000 annually before safety questions arose, Puckett said, adding that about 95 percent of women were happy with their implants.
To win new customers, manufacturers advertise in women's magazines and offer financing plans, and surgeons' Web sites give women the chance to send in photos and view themselves online with different breast sizes.