Test First, Implant Later

Diana Zuckerman, PhD, National Center for Health Research, Akron Beacon Journal, Clarion Ledger, and other McClatchy-Tribune newspapers: March, 2007

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.

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.