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SKIN DEEP

Do My Breast Implants Have a Warranty?

Amaranth Productions

BE PREPARED Dr. Melmed, in a scene from "Absolutely Safe," removes an older-model silicone implant that failed.

By NATASHA SINGER

Published: January 17, 2008

A NAKED woman, her left arm strategically draped over her nipples, grins beatifically at readers in an advertisement for

cosmetic surgery that equates breast implants with a more durable commodity: jewels.

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Amaranth Productions

NOTHING LASTS FOREVER A patient in the anti-implant documentary film "Absolutely Safe."

Schwaberow for The New York Times

Krista Schell needed two follow-up implant operations within five years of her first.

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Schwaberow for The New York Times

Dr. Huang tells patients that implants should be removed within 10 to 15 years.

"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 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

advertisement. 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 the country'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 reoperation, 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 F.D.A. 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 M.R.I.

tests or the reoperations," 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, requiring

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 Inc. and the Mentor Corporation, 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 L. 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 at some future date. 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 Dr. 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, tactile rippling beneath the

skin.Not all doctors, however, are as forthcoming about the risk of additional surgery as Dr. Jewell."My plastic surgeon told me that my saline implants should last forever," said Krista Schell. Ms.

Schell, 29, who lives in Thornton, Colo., and works for the State of

Colorado, 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.Last November, Ms. 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," Ms. Schell said. Doctors nationwide

performed about 329,000 breast augmentations in 2006, up from about

291,000 in 2005, according to a survey of doctors from the American

Society of Plastic Surgeons. But medical experts said they could not

determine exactly how long breast implants may last."The short

answer is, we don't know specifically how long implants last," said

Li, the president of a medical device testing company in

Sarasota, Fla. Dr. Li, who has served on three of the F.D.A.'s panels

that reviewed implant safety, voted to approve silicone implants. He

said manufacturers' data suggested the implants should last at least a

decade. "The current implants are no worse than before and ought to be

better, based on the clinical and laboratory data, which is the only

way you could rationalize approving a device that you have only three

or four years of data for." As a condition of approval, the

F.D.A. 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 companies also developed extensive informed-consent

processes. Caroline Van Hove, the vice president of corporate

communications for Allergan, wrote in an e-mail message that after a

patient goes over a detailed checklist of implant information with her

surgeon, she signs a consent form acknowledging her understanding of

the risks of the surgery. Although the number of reoperations

may seem high — about a third of patients in an Allergan study had a

second operation within four years of their initial surgery — Ms. Van

Hove said that less than a third of the follow-up operations involved

implant removal. Patients also counted as reoperations if they had

surgery to reposition their implants or had biopsies, she wrote. In the

same study, even though 28 percent of silicone implant patients needed

a second operation within six years, 95 percent of patients were

satisfied. But Eugene Goldberg, a biomaterials professor at the

University of Florida,

Gainesville, said the F.D.A. should have required longer-term studies

before it approved these devices. Research conducted by hip replacement

manufacturers, for example, makes it clear that such artificial joints

last roughly 10 to 12 years, he said. "But with breast

implants, informed consent is much more fuzzy because each doctor has

his own perspective on how long they last, making it difficult for

patients to realistically calculate the risks and benefits," Dr.

Goldberg said. He has testified as an expert witness for both

plaintiffs and defendants in implant litigation cases and teaches a

course in which he uses breast implants as a case study of a badly

engineered medical device.Dr. Huang, a plastic surgeon in

Denver, tells patients that their implants should be removed after 10

to 15 years. She said she had removed implants from more than 1,000

patients. She charges about $7,000 for breast augmentation; roughly

$5,000 to remove implants; roughly $7,500 to replace old implants; and

roughly $9,000 for surgery in which she removes implants and performs a

breast lift using the patient's own tissue. "If they would rather spend

their money on a trip to Paris than on me, then I recommend they do not

have breast augmentation to begin with," she said.Surgeons said

that implant replacement can be a straightforward operation. But

explantation surgery, in which a surgeon removes implants for good

along with scar tissue, can be more complicated, particularly for older

silicone models."If the envelope has broken down and the

silicone has leaked out, you are trying to get out all of that goo,"

said Dr. E. Kolb, a plastic surgeon in Atlanta who performs three

to five explantation surgeries a week. To remove scar tissue, which can

adhere to muscles and to the fibrous tissue covering the ribs, some

doctors mistakenly remove too much muscle or breast tissue, which can

cause chest deformities, she said. Given the impermanent nature

of breast augmentation, it is perhaps fitting that a different ad in

the January issue of Elle puts implants on par with a more short-lived

purchase: footwear."You know that feeling when you find the

perfect pair," reads the ad copy running underneath a photo of another

naked, contented-looking woman. "And we are not talking shoes."