Implants Are Back, and So Is the Debate
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.
ALTERNATIVE SOLUTION
While some doctors have objected to the F.D.A.’s guidelines concerning M.R.I.’s to check for ruptures in patients with silicone breast implants, a plastic surgeon in Minnesota is developing a dime-size tool that would detect possible leakage.
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 majority of plastic surgeons, even 99 percent of surgeons, would say there are problems with the directions,” said Dr. Scott L. Spear, chairman of plastic surgery at Georgetown University Hospital. “They bring a lot of red tape and expense.”
As evidence of the recommendations’ unpopularity, he reported that on Tuesday most of about 150 doctors surveyed at a meeting in Coeur d’Alene, Idaho, of the American Association of Plastic Surgeons, a group of leading physicians, said they disagreed with the F.D.A.’s directives.
Other surgeons said that doctors should follow the directions because much remains unknown about the durability and rate of rupture of silicone implants, which were the subject of intense and controversial class action suits in the 1990s.
“If people blow these tests off, it will be detrimental from a scientific standpoint,” said Dr. V. Leroy Young, a plastic surgeon in St. Louis. “Patients will be walking around with failed implants and not know about it.” He said ignoring the directions could increase patient risk and that he would insist his patients have the tests.
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.
In 1992, fearing that the implants may cause chronic disease, the F.D.A. called for a moratorium on them for cosmetic augmentation, although it continued to allow them for breast reconstruction.
But a subsequent study by the Institute of Medicine of the National Academy of Sciences concluded that silicone implants did not cause systemic disease.
Last year, the F.D.A. approved silicone implants made by Allergan and Mentor for cosmetic use in people 22 or older, and for reconstruction for all ages. Besides instructing doctors to advise their patients about the M.R.I.’s and the need for removal, the manufacturers are required to follow their pre-existing study groups of silicone patients for 10 years and to create a database to track 80,000 new patients.
“The guidelines are critically important because we really don’t yet know how best to follow-up these patients, what tests they should get and how often,” said Dr. Michael H. Rosenberg, a plastic surgeon in Mount Kisco, N.Y., who is enrolling women who get silicone implants in a study that will monitor them using M.R.I.’s and ultrasound. “I don’t think it is unreasonable to come up with a standard method to determine the rate of problems with implants.”
To some patients, silicone is worth it, even with the conditions. “The silicone implants look and feel so natural that it doesn’t matter that I will have to spend more money later on M.R.I.’s,” said Katherine John, a substitute schoolteacher in Savage, Minn., who had the surgery last December.
But Ms. Meyer, the bank teller, decided to have saline implants after hearing about silicone’s risks and expenses.
“They told me that if the silicone implant ruptured, it would kind of coagulate in the breast and you wouldn’t feel it,” she said. “The idea that you could be walking around for two years with a rupture until you had the next M.R.I. gave me an uneasy feeling.”
Both women are patients of Dr. Joseph M. Gryskiewicz, a plastic surgeon in Edina, Minn., who is chairman of the emerging trends task force of the American Society for Aesthetic Plastic Surgery.
The debate among plastic surgeons over the F.D.A.’s instructions may have started at a faculty meeting in January at the David Geffen School of Medicine at the University of California at Los Angeles. According to several doctors who attended the meeting, many doctors objected to the guidelines. The group then sent a letter, drafted by Dr. Steven Teitelbaum, a plastic surgeon in Santa Monica, questioning the recommendations to a plastic surgery medical journal.
Last month, at the annual conference of the American Society for Aesthetic Plastic Surgery, in Manhattan, some doctors publicly questioned the recommendations.
“Serial M.R.I.’s are costly, inconvenient and inaccurate,” said Dr. Gryskiewicz, who was a speaker at a breast-implant panel.
Dr. Gryskiewicz said that he nevertheless advises his patients that they will need the tests. But he is also developing an alternative diagnostic tool, called Novalert, a dime-size radio-frequency identification tag that fits on the back of an implant and emits a signal if it senses leaking silicone. “The M.R.I. is the best test we have at the moment, but we need a better system,” he said.
Other doctors said M.R.I.’s occasionally give false-positive results that could cause women with intact implants to have unnecessary surgery to take them out. Still others questioned the advisory to automatically remove a ruptured implant, contending that silicone is benign.
Dr. Richard Ellenbogen, a plastic surgeon in West Hollywood, said he has put in thousands of implants and has never seen major problems. “In my opinion, a rupture is not going to hurt anyone,” he said, adding that “radiologists are going to make a lot of money paying off their $800,000 machines.”
Declining to follow labeling instructions for a medical device is not a legal issue. The F.D.A. regulates drugs and devices, leaving doctors free to practice medicine using approved products in unapproved ways if they deem it medically appropriate.
Supporters of the F.D.A. directives point to studies published in the European Journal of Radiology and the Annals of Plastic Surgery, which found that M.R.I.’s detected ruptured silicone implants with 89 percent accuracy while doctors detected them with 30 percent accuracy.
“These doctors are asking patients to embrace a risk that the patients don’t even know exists,” said Dr. Amy E. Newburger, a dermatologist in Scarsdale, N.Y., who was on the F.D.A. panel that reviewed silicone implants and voted against approval.
Source: Natasha Singer; The New York Times; http://www.nytimes.com/2007/05/24/fashion/24skin.html
