Tags: FDA | Should | Not | Reapprove | Silicone | Breast | Implants

FDA Should Not Reapprove Silicone Breast Implants

Wednesday, 03 August 2005 12:00 AM

There is a medical dictum that asserts you must always consider the risks vs. the benefits of any procedure. Silicone breat implants are high risk and low benefit!

Breast implants are not a life-or-death necessity, and there are saline alternatives.

At best, cosmetic breast implants are a plastic surgical procedure but not in the classical sense of curing a serious congenital or developmental disorder or restoring form and function to a damaged part of the body from injury or radical surgery. An exception to this is breast implants following mastectomy for cancer, which certainly are medically indicated and warranted.

At worst, breast implants are a vanity procedure performed too often on too many women by too many alleged plastic surgeons.

Approximately 250,000 breast implants and 250,000 reduction mammoplasties are done per year.

Silicone-gel implants bounced onto the market in 1962, before the FDA required proof that all medical devices be safe and effective.

They were banned in 1992 because of health concerns. The implants have been for the most part exonerated of junk science concerns that they might cause serious or chronic illnesses, such as cancer, lupus or collagen diseases.

Although they were exonerated of blame, we have yet to see any of the patients, plaintiffs or trial lawyers return any of the hundreds of millions of dollars they reaped from the lawsuits. To assume there will be no more problems and lawsuits is like thinking that al-Qaida won't attack America again.

Aside from the risk of breakage, these implants can cause infection and painful scar tissue. And they will do so again!

The FDA committee voted 7-2 on April 13 to recommend allowing them back on the market under certain conditions. Women must understand that the devices might break silently inside their bodies, and the FDA recommended that women get regular MRI exams to check for such breaks. The FDA also stated that only specially trained plastic surgeons should be allowed to perform implant insertions, and they required new studies to prove how long implants last.

To assume that these recommendations will be followed faithfully is a giant leap of faith. Also, who will decide who is qualified to do the surgery? There are many surgical specialties that perform breast implants with many surgeons who call themselves plastic surgeons.

The surgical turf wars will take years to battle and litigate. And some women will always value-shop for the cheapest surgeon regardless of warnings!

The FDA's confirmation of its intent to approve the implants occurred even though the Senate Health, Education, Labor and Pensions Committee is still investigating the advisory committee's recommendation from four months ago.

A band of female senators led by Sens. Dianne Feinstein, D-Calif., and Olympia Snowe, R-Maine, urged the FDA last Thursday to consider women's safety before the agency makes a final decision.

Women who want the product's return say silicone-gel implants feel and appear more natural than the saltwater-filled implants currently sold without restriction. But other women told the advisory panel stories about gel oozing out of their breasts and body and years of pain and other symptoms.

Diana Zuckerman, president of the National Research Center for Women & Families, who has argued that the devices are not proven safe, called the action "shocking."

It seems to us that the FDA is acting irresponsibly and that reapproval will only lead to repeat problems.

If the FDA wants to revisit prior decisions it deems poor or in error, perhaps it should re-evaluate its recent bans on non-steroidal anti-inflammatory agents (NSAIDS) such as Celebrex, Vioxx, Bextra and Mobic. With 50 million patients in chronic pain from arthritis and defenerative disc disease, that would seem far more reasonable.

Health concerns for women should override a vanity implant for which there is a safe saline substitute. The FDA should make better usage of its time and our money. Finally, it should never give those (legal blood) suckers a second chance.

Robert J. Cihak, M.D., is a Senior Fellow and Board Member of the Discovery Institute and a past president of the Association of American Physicians and Surgeons. Michael Arnold Glueck, M.D., is a multiple-award-winning writer who comments on medical-legal issues.


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There is a medical dictum that asserts you must always consider the risks vs. the benefits of any procedure. Silicone breat implants are high risk and low benefit! Breast implants are not a life-or-death necessity, and there are saline alternatives. At best,...
Wednesday, 03 August 2005 12:00 AM
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