COMMENTARY

Dangerous Laxity on Medical Implant Safety

By Diana Zuckerman

October 14, 2002

The news about the checkup on Vice President Dick Cheney's heart and pacemaker came just as key congressional negotiators were meeting behind closed doors to craft a law on all medical devices -- including Cheney's implant. It would be nice if a new law gave all patients a free one-year checkup for their implants, like Cheney's. Instead, the proposed law would make it easier for dangerous implants to stay on the market.

In the year of Enron and WorldCom, the Food and Drug Administration is urging Congress to give a free pass to medical device manufacturers that are too busy to conduct long-term safety research on the implants they sell. Apparently, medical device manufacturers are so honest that they don't need independent oversight. Instead, the proposed law would speed up the approval of implants and other lifesaving medical devices without any new protections to make sure the heart valves and other implants were safe for long-term use.

Why worry? Although concerns about prescription drug prices, a possible war with Iraq and other issues have dominated headlines, the last few months have brought mind-boggling news stories questioning the safety of implants and other medical devices.

Here are a few examples:

* U.S. News & World Report published a story saying gastric lap bands, bladder slings, jaw joints and other implants had caused deaths and irrevocable damage to thousands, many of whom wanted to lose weight or had relatively minor health problems before surgery.

* In July, the FDA quietly held a meeting to discuss data collected over five years on saline breast implants, which indicated that, on average, patients suffered from several serious complications and many required at least two additional surgeries during the first five years.

* In August, the Newark (N.J.) Star-Ledger reported that device manufacturers had covered up patient deaths and severe adverse reactions instead of reporting them to the FDA as required by law. And when companies finally reported them, the FDA did nothing to penalize the companies for wrongdoing.

With so much attention on the cost of prescription drugs, few Americans have been concerned about medical implants. Meanwhile, we are rapidly becoming a nation of people with implanted parts. Who among us doesn't have a friend or relative with an implant of some sort? My baby-boomer brother has a hip replacement, my mother-in-law has new knees, a cousin's baby is relying on a shunt and several friends have complications from the breast implants they chose after mastectomies. I wonder how many of them have annual checkups for their replacement parts the way our vice president does.

Many implants have been on the market since before 1976, when the FDA first was given authority to regulate medical devices. Although they had been on the market for years, heart valves, shunts, breast implants, jaw implants and many other devices were approved by the FDA after only short-term studies following patients for, in some cases, just a few weeks or months.

Even though patients will need these implants for the rest of their lives, the FDA rarely requires studies to find out what happens five or 10 or 20 years later. Even worse, newly designed implants are sometimes approved based on scanty data if the company convinces the FDA that the implants are "substantially equivalent" to other previously approved implants.

It's not too late for Congress to listen to its own rhetoric about the need for independent oversight of the business world and apply it to medical device companies. If that doesn't happen, then patients and other buyers will just have to beware. Perhaps instead of birthday and anniversary cards, we should start sending friends and relatives annual reminders to get checkups on their implants. If patients don't take matters into their own hands, we may never find out whether these implants are safe until it is too late.


Diana Zuckerman is president of the National Center for Policy Research for Women & Families, a nonprofit research-based organization in Washington, D.C., that analyzes health policies. E-mail: dz@center4policy.org. For information about reprinting this article, go to http://www.lats.com/rights.