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Jewish World Review August 5, 2005 / 29 Tammuz, 5765 High risk with low benefit — FDA should not reapprove silicone breast implants By Drs. Michael A. Glueck & Robert J. Cihak
http://www.JewishWorldReview.com |
What on Earth is the FDA thinking? Haven't they ever heard the old adage,
Fool me once and it's your fault but fool me twice and it's my fault.
Following the recommendations of an advisory panel, the Food and Drug
Administration last Thursday, July 28, told one device company that its
implants can be approved under certain conditions. So, following a 13-year
hiatus, silicone-filled breast implants are another step closer to
returning to the market.
But why? With all the time, energy, aggravation, money lost, lawsuits,
destruction of companies, and pain and suffering associated with the
initial product why do we want to chance harming more women and give the
lawyers another shot to make even more billions. The trial lawyers must be
slobbering down their pinstriped blue and charcoal custom suits.
There is a medical dictum that asserts you must always consider the risks
vs. the benefits of any procedure. Silicone breast 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 on 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 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 Al Queda won't attack America again.
Aside from the risk of breakage, these implants can cause infection and
painful scar tissue. And they will 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 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
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.
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 it's time
and our money.
Editor's Note: Michael Arnold Glueck penned this week's commentary.
Every weekday JewishWorldReview.com publishes what many in in the media and Washington consider "must-reading". Sign up for the daily JWR update. It's free. Just click here.
Michael Arnold Glueck, M.D., is a multiple award winning writer who comments on medical-legal issues. Robert J. Cihak, M.D., is a Discovery Institute Senior Fellow and a past president of the Association of American Physicians and Surgeons. Both JWR contributors are Harvard trained diagnostic radiologists. Comment by clicking here. © 2005, |
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