By NATASHA SINGER

With silicone breast implants back on the market, a debate over follow-up care is roiling the plastic surgery community, even as more women are choosing to have their breasts surgically enlarged. When the Food and Drug Administration decided last November to again allow the use of silicone for breast augmentation, it did so provided that manufacturers instruct doctors to advise patients they will need biannual M.R.I.'s to check for ruptures and should remove the implants if a rupture is detected.

But some surgeons are criticizing the recommendations, saying they are bureaucratic and unscientific and that they interfere with their ability to tailor diagnosis and treatment to each patient. Some said they would not recommend the M.R.I.'s, while others said they would follow the recommendations, albeit unenthusiastically.

The F.D.A., criticized by some health advocates for allowing the silicone implants back onto the market, said it would monitor whether its recommendations were being followed.

"We are certainly going to be looking into the compliance with the M.R.I.'s by doctors and patients," said Donna-Bea Tillman, director of the F.D.A.'s office of device evaluation.

Ms. Tillman said the agency had determined that silicone-gel-filled implants are safe and effective for women 22 or older who receive the appropriate follow-up care. She added that it was not clear how using the devices without following the recommendations may affect safety and efficacy.

The two largest plastic surgery associations said they strongly advise members to adhere to the guidelines. Mentor Corporation, which makes silicone implants, said it supports the product labeling. The other implant manufacturer, Allergan Inc., said that it encourages physicians and patients to follow the recommendations and that it offers training for physicians to understand them.

About 330,000 cosmetic breast augmentations were performed in the United States in 2006, up from about 291,000 in 2005, according to statistics from a survey of doctors conducted by the American Society of Plastic Surgeons. These numbers do not include patients who had implants for reconstruction after breast cancer.

Breast augmentation surgery can cost from $4,500 to $10,000, including silicone implants - which are more expensive - or saline implants, surgeons' fees and operating-room costs. Health insurance does not typically cover cosmetic procedures.

But even as more women choose breast augmentation, surgeons have been engaged in a heated debate over how best to monitor and treat silicone patients.

Doctors must go over a checklist about risks and follow-up care with every patient seeking silicone implants, according to manufacturers' guidelines. And in advising them to get an M.R.I. every two years starting the third year after the surgery, doctors said they also inform patients of an additional cost of $1,000 to $2,200, which is unlikely to be covered by insurance.

The tests deter some patients.

"If you added up all the M.R.I.'s you would need over the years, I figured the cost of the tests would soon outstrip what you paid for the actual augmentation with silicone," said Michelle C. Meyer, a bank teller in Waseca, Minn., who got saline implants last week.

There are differences between silicone implants, which are rubbery shells containing silicone gel, and saline implants, shells containing saltwater. Silicone implants are said to be more lifelike and fleshier.

When a saline implant fails, it deflates quickly and visibly like a water balloon while the saltwater is absorbed by the body. But a silicone implant may break without a person knowing, and the material is not absorbed; the gel may remain in the breast area, contained by a wall of scar tissue, or it could migrate and cause problems such as painful lumpy nodules, doctors said.

It was the phenomenon of leaking silicone that triggered a prolonged legal fight and a moratorium on the use of silicone implants 15 years ago.

The implants were introduced for commercial use in the 1960s by Dow Corning. But in the 1970s and 1980s, some women with the implants experienced hardened breasts, aches and fatigue. Thousands sued Dow Corning, which eventually filed for bankruptcy, and other implant companies.

excerpted from:
"Implants Are Back, and So Is Debate "
By NATASHA SINGER
© New York Times May 24, 2007