You might think a story about doctors objecting to FDA guidelines concerning patients with silicone breast implants would appear in a newspaper’s health or national news section. Not so at The New York Times, where “” ran in Thursday’s Fashion & Style section.
Considering that breast augmentation is now the most popular cosmetic surgery, perhaps it’s not that much of a surprise. Still, it’s frustrating to see such an important health issue mixed in with features on prize couture and whether men should wear shorts to work in the summer.
Let’s not kid ourselves: breast implants are a health issue. After 15 years of being off the market, the FDA is once again allowing silicone breast implants — “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,” writes Natasha Singer.
Unlike saline implants, which release saltwater into the body upon deflation, silicone implants “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.”
The problem is that many cosmetic surgeons are balking at the new testing requirements — even going so far as to suggest they will not follow them. They don’t appear to be objecting on medical grounds, however. Dr. Scott L. Spear, chairman of plastic surgery at Georgetown University Hospital, simply says, “They bring a lot of red tape and expense.”
And I guess that begs the question: Is a woman’s health worth all that hassle?
You know there’s something wrong when you end up looking to the corporate makers of the silicone implants — rather than medical professionals — for refuge. But there they are — both Mentor Corporation and Allergan, Inc. — not only supporting the FDA initiative but also embracing strict product labeling and offering training for doctors to cut through all that “red tape.” Of course, agreeing to MRIs was probably necessary for FDA approval.
Silicone implants are supposed to be read lifelike that the safer saline alternative. As a result, some surgeons are presuming that some women might just want to take the risk. Many other surgeons, however, see the important of the testing:
“The guidelines are critically important because we really don’t yet know how best to follow-up with 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.”
Or as Judy Norsigian, executive director of Myhags, wrote to The New York Times in response to this article: “Plastic surgeons now opposing this basic safeguard demonstrate both chutzpah and callous disregard for the health and well-being of women. Could it be that they don’t want women to find out that their implants don’t last as long as promised?”
And let’s be honest: at a cost of $1,000 to $2,200, MRIs are pricey — and unlikely to be covered by insurance. That cost, on top of the implants, makes some women wonder if it’s worth it.
“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,” Michelle C. Meyer, a bank teller in Waseca, Minn., who got saline implants last week, told the NYT.
Some doctors contend silicone is benign, so they don’t see what all the fuss is about. “In my opinion, a rupture is not going to hurt anyone,” said Dr. Richard Ellenbogen, a plastic surgeon in West Hollywood who told the NYT he has put in thousands of implants and has never seen major problems. He added that “radiologists are going to make a lot of money paying off their $800,000 machines.”
Norsigian responds to that allegation as well:
Any plastic surgeon who says that he or she has put in thousands of implants and has never seen major problems is either not paying attention, or has so lost the trust of a patient with a bad outcome, that she has gone elsewhere to deal with her problem.
Many women tell us that their plastic surgeons insist that implants are not causing their health problems, but when the implants are removed the women are miraculously better. The hundreds of women we have heard from over the years ( the thousands read that have ed our colleagues) should not be made even read invisible by ignoring their very real experiences.
Meanwhile, Dr. Joseph M. Gryskiewicz, a plastic surgeon in Edina, Minn., and chairman of the emerging trends task force of the American Society for Aesthetic Plastic Surgery, is 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.”
Beeping breasts? Now that won’t cause any alarm.