Inadequate Oversight by FDA for Pacemakers, Defibrillators and Other Medical Equipment

The public outrage directed at the FDA for its lax regulation of drugs may turn out to be mild in comparison to the reaction to its lack of safety oversight for certain medical devices. The agency regulates more than 1,700 types of devices, from high-tech surgically implanted pacemakers and defibrillators to basic bandages and thermometers — and I use the term “regulate” loosely. The standards vary widely from one type of device to another, and we are hearing report after report of the considerable dangers — including death — that some medical devices pose to consumers.

The problem is huge. You may be surprised to learn that more than 4% of the US population has an implanted medical device… more than 500,000 medical device malfunctions have been reported to the FDA since 2000… and there are more than 2,000 device-related deaths each year.

Early this year, the Government Accountability Office issued a dismaying report on the FDA’s regulatory process for high-risk devices. The report was followed a few months later by charges made by nine of the FDA’s own physicians and scientists, who said that the regulatory review process for medical devices and the science involved has been severely distorted, and that patients have routinely and illegally been put at risk in spite of experts’ sometimes unanimous objections. The FDA has now instructed the manufacturers of 20 types of medical devices (including external defibrillators, pacemaker components and artificial lung membranes) brought to market before 1976 to submit safety and effectiveness information to the agency so it can better evaluate their risk levels. The goal is to bring these devices to a level that is closer to what is required of those submitted after 1976. Finally, manufacturers must demonstrate reasonable assurance of safety and effectiveness — more than three decades after Congress initially demanded more oversight. I placed a call to William H. Maisel, MD, MPH, founder and director of the Medical Device Safety Institute (www.mdsr.ecri.org) for an update on what consumers can expect.

A Spotty Record at the FDA

Dr. Maisel told me that prior to the 1970s, the FDA had very limited authority over medical-device safety. Then, following the complications caused by the infamous Dalkon Shield IUD (including some deaths due to infections), nominal regulation in the form of the Medical Device Amendments of 1976, was instituted. The amendments established three regulatory classes for medical devices, based on the degree of control necessary to assure that devices in each category are safe and effective…

Class I: These devices present minimal potential for harm to the user and are typically simpler in design than Class II or Class III devices. Examples include enema kits and elastic bandages. Nearly half (47%) of medical devices fall into this category, and 95% of these are exempt from the more stringent regulatory process, though they must conform to “good manufacturing process” standards in a variety of areas, such as sterility.

Class II: Examples of Class II devices include powered wheelchairs and some pregnancy test kits, with 43% of medical devices falling into this category. Class II devices must submit premarket proof that the new device is at least as safe and effective as similar devices already on the market.

Class III: Ten percent of medical devices fall into this category. These devices usually sustain or support life, are surgically implanted or present potential unreasonable risk of illness or injury. Examples of Class III devices include pacemakers and breast implants. Most Class III devices require Premarket Approval (PMA), a somewhat more rigorous process that usually requires submission of clinical data to support claims of safety and effectiveness.

Failures Have Tragic Consequences

When vulnerable patients facing possible disability or death are given little or no reliable safety information as they are offered a life-saving solution, it’s understandable that they’re inclined to say yes. Unfortunately, however, there are many situations where consequences have ranged from the uncomfortable to the tragic, including these two particularly egregious examples:

  • In 2007, Medtronic voluntarily withdrew its Sprint Fidelis heart defibrillator lead device from the market, announcing that “the product did not meet expectations.” The action followed five patient deaths and numerous reports of patients suffering repeated inappropriate shocks due to fracturing of the leads. Meanwhile, an estimated 150,000 Americans still have these leads and removing them is expensive, complicated and risky. At least four people have died during surgical extractions to replace faulty ones. While most patients won’t have problems, it remains a serious safety concern.
  • In 2006, the Mentor Corporation (now owned by Johnson & Johnson) stopped selling a device called ObTape, designed to stop urine leaks in women. At least 198 adverse events were reported to the FDA between 2003 and 2006. Many of the women who had these hammock-like vaginal slings inserted to solve their minor urinary leakage problems ended up with major problems including pain, bleeding and infection. Many now are having the slings surgically removed.

No Legal Recourse?

To further complicate matters, consumers have limited rights if something goes wrong. Patients cannot seek compensation from manufacturers for injuries, health expenses or lost wages due to malfunctions of FDA-approved medical devices. Not only does this ruling have an immediate negative impact on consumers (more than 1,000 lawsuits involving Sprint Fidelis have already been dismissed), the lasting physical and emotional damage may be far worse. Dr. Maisel points out that shielding medical device manufacturers from liability lawsuits removes a powerful economic incentive for companies to focus on safety. The FDA has announced that it is creating a task force to evaluate safety concerns and alert consumers to potential dangers, but Dr Maisel notes that the agency historically has relied heavily on the device industry’s own private data.

Making matters worse, it’s very difficult for consumers to know where to turn for safety data to help them decide whether or not to follow through with a physician-recommended “prescribed” medical device. Organizations such as Dr. Maisel’s Medical Device Safety Institute are working to make information about medical devices easier to obtain and consumer-friendly. The FDA has formed a new “Transparency Task Force” whose mandate is to make recommendations on simplifying and making information publicly available in a more timely manner. Congress, too, is making headway toward this goal with such efforts as a recent bill to create a National Medical Device Registry. “These are the types of efforts we need,” says Dr. Maisel, “but unfortunately, it’s unlikely that comprehensive information will be available anytime soon.” At present, he says, the best you can do is visit reputable Web sites such as that of the American Heart Association (www.americanheart.org) or the American Academy of Orthopaedic Surgeons (www.aaos.org) to learn more about specific types of devices.

Learn more about medical-device safety and read about product alerts at www.mdsr.ecri.org.

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