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2 février, 2008 14:02

By NATASHA SINGER

New York Times News Service

A naked woman, her left arm strategically draped over her nipples, grins at readers in an advertisement for cosmetic surgery that equates breast implants with a more durable commodity: jewels.

"You know that feeling when you find the perfect size," reads the copy for the Natrelle Breast Enhancement Collection that ran in the November issue of Elle magazine. "And we're not talking diamonds."

It is the kind of marketing analogy that gives breast implants a bad name. Diamonds, as De Beers and a James Bond novel once suggested, are meant to last forever. But breast implants often do not.

"Breast implants are not lifetime devices, and breast implantation is not necessarily a one-time surgery," reads a warning in much smaller type on the back of the ad.

Indeed, whether women initially underwent implant surgery for cosmetic reasons or for reconstruction after breast cancer, roughly one-third of patients in clinical trials had a second operation within four to five years, according to statistical tables in the ad.

Almost two decades after a national hue and cry arose after fears that leaking silicone breast implants might cause systemic disease, breast augmentation has become America's most popular cosmetic operation. The renaissance of breast enhancement surgery is fueled in part by the Food and Drug Administration's decision in 2006 to approve a new generation of silicone implants, ending a 14-year moratorium on their general use.

But with such high rates of re-operation, a new debate is emerging over whether breast implants constitute the kind of annuity medicine that will entail regular surgical tuneups, exposing patients to increased medical risk and out-of-pocket expenses. At a time when manufacturers have provided the FDA with clinical studies that follow patients for just a few years, there is no established medical consensus on how long implants last, leaving doctors to rely on their anecdotal experiences when discussing durability with patients.

Given the lack of such data, critics said, women may not be prepared in the long term for the ordeal or financial burden of subsequent surgery.

"Your implants may last less than 10 years or more than 10 years, but when you start having problems with them, your health insurance is unlikely to cover the MRI tests or the re-operations," said Carol Ciancutti-Leyva, the director of a 2007 anti-implant documentary called Absolutely Safe. "It can be a very expensive proposition, especially if you are young."

Many women are aware that implants can break down over time and require replacement, just like car tires. Both saline implants, made out of a saltwater solution, and silicone implants, made out of gelatinous silicone, can form minute tears in their rubbery shells, causing ruptures. In the case of such defects that require product replacement, both manufacturers, Allergan and the Mentor Corp., offer guarantees. Mentor has a 10-year guarantee to replace implants and defray some surgical fees; Allergan's warranty includes lifetime implant replacement and up to $1,200 for fees for the first 10 years.

Dr. Mark Jewell, a plastic surgeon in Eugene, Ore., who is a past president of the American Society for Aesthetic Plastic Surgery, said he warns his patients that breast augmentation surgery automatically guarantees a second operation later. He added that many patients in clinical studies had elected to have follow-up operations to change implant type, size or position.

"Women are used to having their hair or nails done on a regular basis to maintain their appearance," said Jewell, who has conducted clinical trials for both implant manufacturers and is a consultant for Allergan, the manufacturer behind the ads running in Elle. "Ultimately, breast implants may also be a matter of maintenance."

But a rupture is only one of the local complications that may engender additional surgery. Like cocoons that grow around larvae, scar tissue can form around implants; and sometimes that scar capsule hardens and squeezes the implant, causing pain and deforming breasts. And saline implants can cause visible rippling beneath the skin.

Not all doctors, however, are as forthcoming about the risk of additional surgery as Jewell.

"My plastic surgeon told me that my saline implants should last forever," Krista Schell said.

Schell, 29, who lives in Thornton, Colo., and works for the state, said she first spent $6,500 in 2003 on breast enhancement surgery with a doctor in California. She had a second operation with that doctor last April to replace a deflated saline implant whose collapse made her left breast look "hollow"; her implants were still under warranty, but she did have to pay for the trip to California and lost a week's pay, she said.

In November, Schell had a third operation, which cost $6,000, this time with a surgeon in Denver who removed both implants as well as extensive scar tissue, she said. She also lost two weeks' wages because she had to take time off, she said. The implants had also caused rippling, a lump around one nipple and pain.

"If you look at the negatives, you would talk yourself out of getting implants," Schell said.

As a condition of approval, the FDA asked silicone implant makers to follow their existing study groups for 10 years total and to enroll 80,000 new patients in a database. Both Allergan and the Mentor Corp.also developed extensive informed-consent processes.