Feds to Keep Silicone Breast Implant Ban

[PhiPsiRuss]

Original Story

By LAURAN NEERGAARD, AP Medical Writer

WASHINGTON - The government will continue its decade-plus ban on most silicone gel breast implants for now, health officials announced Thursday, saying they still have serious questions about how often the devices break apart and the damage that can result.

The Food and Drug Administration rejected Inamed Corp.'s bid to bring back silicone implants, and outlined new guidelines for all manufacturers on the scientific issues that must be settled if the devices ever are to return to the market.

Key is answering questions about the gel that can ooze into a woman's breast, and sometimes beyond, when the implant breaks.

"We're quite convinced that there are women who have these products and get a very satisfactory result," said FDA medical device chief Dr. David Feigal. "The point isn't to talk about how many have a good result and how many have a rupture. What you really need to know is, for someone who has a rupture, what are the consequences of that?"

The FDA's move doesn't end strictly controlled research studies that make the once highly popular implants available to some women with breast cancer and a few other conditions.

But it could delay for several more years the return of silicone implants, meaning the main option for most women, especially those who want bigger breasts, will remain implants filled with salt water. Some 236,000 American women underwent breast enlargement in 2002.

Inamed expressed disappointment but pledged to seek FDA approval again.

"We see this as a setback but by no means do we see this as the end of the road," Inamed chief executive Nick Teti told financial analysts late Thursday. "We are confident we can provide the information," but he wouldn't estimate how long it would take.

Inamed had argued that silicone implants break no more frequently and are no riskier than saline-filled ones. In studies tracking women for three years so far, up to 46 percent of Inamed recipients needed additional surgeries because of painful scar tissue and other complications, and up to a quarter had to have the devices removed or replaced.

Mentor Corp., a competitor, filed an FDA application for its silicone implants last month, and didn't immediately comment on whether it could meet the guidelines.

The decision delighted women's and consumer advocacy groups that had intensely lobbied the FDA to keep the implants banned.

"At last they've heard us," said Sybil Goldrich, a breast cancer survivor who first complained about implants to the FDA 15 years ago. Goldrich went through four sets of broken implants in the 1980s.

Now that FDA has provided explicit advice to manufacturers, "I really hope they'll be able to make a product that works," she said. "If we can put a man on the moon and get a little machine to explore Mars, it seems to me you could make a good breast implant."

But the move disappointed plastic surgeons, who say silicone implants have been exonerated as causes of serious disease, are more natural-looking than saline alternatives — and that recipients understand that, just like pacemakers or artificial hips, they don't last forever.

"We support the scientific process" but "it seems they're changing the rules in the middle of the game here," said Dr. Rod Rohrich of the University of Texas Southwestern Medical Center, who is president of the American Society of Plastic Surgeons.

"It would have been laudable for the FDA to give these guidelines to the manufacturers a long time ago."

But Feigal responded that evolving science raised new questions which researchers now should be able to answer.

The FDA's decision was a surprise because the agency's scientific advisers in October had reluctantly recommended, on a 9-6 vote, approving Inamed's implants. Instead, FDA incorporated that panel's lingering concerns into the new guidelines. Companies must: settle whether women whose implants leak silicone without symptoms need them removed, do mechanical testing to predict how long implants will last before rupturing, and do more detailed exams of what happens when silicone leaks beyond the breast.

"The products do not have to be complication-free," Feigal stressed — no medical device is. "We very much would like to work with manufacturers so they can find products which will provide options and will have an acceptable" list of side effects.

Breast implants began selling in 1962, before the law allowed the FDA to require proof that all medical devices are safe and effective. Complaints that they broke and caused illnesses began in the 1980s, and in 1992 the FDA's virtual ban began.

Thousands of women sued the manufacturers; many suits ended in a major settlement approved in 1999. That same year, the Institute of Medicine declared there was no evidence that implants cause major illnesses like breast cancer or lupus, but warned that breaking, pain and other complications occurred frequently.
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This is just wrong.

[James]

This Nation is founded on basic liberities . . all women should have access to inexpensive and convenient Breast Augmentation.

There should be government assitance for it.

[absolutuscchick]

Originally posted by James
This Nation is founded on basic liberities . . all women should have access to inexpensive and convenient Breast Augmentation.

There should be government assitance for it.

Right......

I'm personally not a fan of fake boobs. Yes, I definitely don't have large breasts at all, but I've never gotten any complaints. Also, why have an unneccesary surgery where you have the possibility of complications??

[DWAlphaGam]

As of 2001, silicone breast implants were #4 on the list of FDA's most-reported medical device failures (there are over 5000 classes of medcial devices, just to give you an idea of what that means). FDA is perfectly justified in continuing the ban until they get more information on what exactly silicone can do when it leaks inside the body.

[James]

Well . . lol . . . ephedra the herb has just been taken off . . .

But ephedrine the drug is in every cough medicine and allergy medicine out there . . . if its killing people why is it allowed to stay in those meds?

[DWAlphaGam]

FDA's main ephedra page: http://www.fda.gov/oc/initiatives/ephedra/december2003/

FDA's consumer advisory: http://www.fda.gov/oc/initiatives/ep.../advisory.html

The totality of the available data showed little evidence of ephedra's effectiveness except for short-term weight loss, while confirming that the substance raises blood pressure and otherwise stresses the circulatory system. These reactions have been conclusively linked to significant adverse health outcomes, including heart ailments and strokes.

Ephedra, also called Ma Huang, is a naturally occurring substance derived from botanicals. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated under the Federal Food, Drug and Cosmetic Act of 1938 as a drug. In contrast to the DSHEA-regulated dietary supplements that contain natural ephedra, the safety and effectiveness of the synthesized ephedrine has to be proven by the manufacturer, not the FDA. In recent years ephedra products have been extensively promoted for aiding weight control and boosting sports performance and energy.

Today's announcement is a continuation of a process that started in June, 1997 when FDA first proposed to require a statement on dietary supplements with ephedra warning that they are hazardous and should not be used for more than 7 days. FDA modified this proposed rule in 2000, and in February 2003 it announced a series of measures that included strong enforcement actions against firms making unsubstantiated claims for their ephedra-containing products.

The answer to your question, James, is that ephedra isn't regulated as strictly as ephedrine is, because ephedra is classified as a dietary supplement and ephedrine is classified as a drug. FDA doesn't have much control over dietary supplements; FDA basically has to take the manufacturer's word for their effectiveness and safety, and they don't have to undergo the same rigorous clinical trials that drugs do. Every drug containing ephedrine has been proven safe and effective, or else it would not be on the market.

Additionally, if you read the labels of your medicines, most of them say not to take the drug for more than 7 days without a physician's supervision. If you notice in the quote above, FDA also recommended the same for ephedra, but of course people trying to lose weight are probably not going to stop taking it after 7 days. Also, if someone is overweight, they likely already have high blood pressure and other stresses to their circulatory system, which are aggravated by the side effects of ephedra.

Unless you were a major investor in Inamed, I don't see how anyone could be that distraught over the FDA's ruling.

I think the importance should be placed on the woman's health and safety, not the decrease in jugs you men get to ogle at.