Dr. Zuckerman: Are Med Devices Safe?

Brought to you by Ilena Rosenthal, Director, Humantics Foundation.
www.BreastImplantAwareness.org

March 29, 2007

Are med devices safe?

By Diana Zuckerman
McClatchy-Tribune Information Services



Gerald Herbert/The Associated Press/File photo

Dr. David Graham, associate director of science for the office of drug
safety at the center for drug evaluation and research for the Food and
Drug Administration, testifies before a Senate Finance Committee
hearing on "The FDA, Merck and Vioxx: Putting Patient Safety First?"
on Capitol Hill in Washington in this Nov. 18, 2004, file photo.

If you care about your own health and the health of family members,
keep reading. The good news is that scientists and physicians are
working tirelessly to develop new treatments to prevent and cure a
wide range of diseases.

But, new treatments usually come with risks, and the bad news is that
scientific concerns about those risks are being ignored by the very
people we depend on to keep us safe.

After a three-year investigation of the FDA, our research center has
found that the FDA makes it shockingly easy for companies to get their
medical products approved. While the greatest public attention has
focused on prescription drug disasters such as Vioxx, the most
outrageous FDA shortcomings are for products known as medical devices
- contact lens solution, heart valves, stents, implants, LASIK
devices, and facial injections to make us look young again.

You may not even have heard about this month's recall of a Bausch and
Lomb contact lens solution, but it is just one more example of how
products that we take for granted - in this case, a product that
millions of people use every day - may not be as safe as we thought.

The most controversial medical device in U.S. history has been the
silicone breast implant, and recent news stories that Anna Nicole
Smith suffered from lupus, a painful autoimmune disease that has been
linked to silicone implants, once again raise the question of whether
implants are safe.

The FDA approved silicone breast implants despite their own
scientists' reports of an increase in painful autoimmune symptoms
among women with silicone implants. And, because of concern that
silicone leakage could cause illness and deformities, the FDA warns
women to get expensive MRI screening tests every other year to check
for leakage - at a cost of at least $2,000 each test. In addition, the
FDA required the implant makers to study at least 80,000 women for at
least 10 years to find out more about the long-term risks of
autoimmune diseases. Aren't they supposed to require proof of safety
before approval, not after?

Our research center determined that this was standard procedure for
the FDA, which does not require clinical trials (the gold standard)
for most medical devices, even though such studies are required for
prescription drugs.

The latest implant scandal involves stents, which are potentially
life-saving small metal mesh tubes implanted during heart surgery to
prop open arteries. Three years ago, the FDA approved a new kind of
stent that slowly released a medication, aimed at making the stents
more effective.

Unfortunately, it was not until after 6 million people had these
stents implanted in their bodies that the FDA concluded that medicated
stents increased the chances of potentially fatal blood clots. Experts
are now saying that many of the patients who truly need stents might
be better off with the old-fashioned kind that don't release
potentially dangerous medication.

The FDA has responded by requiring new warnings on stents, and
surgeons are being encouraged to use stents less often and only when
the benefits are most likely to outweigh the risks. The warnings
should have been made when the stents were first approved, not 6
million patients later. Long-term studies should have been required
years ago. If you or someone you love has these drug-releasing stents
in your body, you are part of an unintended experiment.

Today, the bad news is about stents and contact lens solution; last
year, it was silicone implants and defibrillators. What's next? There
is not a family in the United States that does not rely on the safety
of medical devices for at least one family member, whether they use
contact lenses, hearing aids, heart valves, artificial hips, LASIK
surgery, Botox or bandages. As baby boomers age, we are relying
increasingly on replacement parts to keep us going. What can we do now
to avoid disaster later?

Congress has decided to pass legislation aimed at improving the safety
of drugs, but it has not considered laws to protect patients and
consumers from unsafe medical devices, even those implanted inside our
bodies or used in our eyes. We all need to let our government know
that we expect our medical devices as well as our prescription
medication to be proven safe - before they are sold to us, not
sometime later.

Meanwhile, read the fine print before you use a medical device in a
part of your body that you care about.


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Diana Zuckerman is president of the National Research Center for Women
& Families, 1701 K St. NW, Suite 700, Washington DC 20006; contact the
center's Web site: www.center4research.org.