So You Think Your Medical Device Was Safety Tested? Think Again.
Posted by: Salvatore J. Zambri, founding member and partner
Medical devices such as artificial joints, heart defibrillators and surgical mesh have become an integral part of the healthcare industry. As consumers, we would naturally expect that those devices have been tested for safety and effectiveness. In reality, many implants and other high-risk devices on the market have not undergone any safety testing. Rather, the manufacturers have frequently only filed paperwork and paid the mandatory FDA user fee to market those items.
In 2011, the Institute of Medicine of the National Academies, an independent, non-profit organization that works outside of the government to provide unbiased and authoritative advice to decision-makers and the public, released a consensus report concluding that "the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle." In summary, they recommended that the FDA completely overhaul its system that regulates medical devices because presently it doesn't ensure patient safety either before or after products are on the market. Surprisingly, Congress is currently working on a new law that neither addresses the failures of the current FDA process nor forces manufacturers to sufficiently safety test devices. Rather, its goal is to allow them to market devices even faster. That's a shame.
A recent investigation by Consumer Reports illustrates several issues related to patient safety and medical devices:
- "Medical devices often aren’t tested before they come on the market.
- There’s no systematic way for the government, researchers, or patients to spot or learn about problems with devices.
- Without major changes in the system, there’s not much that patients can do to protect themselves."
The Consumer Reports article provides examples of patients who suffered unnecessarily from devices that were never sufficiently tested for safety before they were marketed and used on real patients:
- Transvaginal surgical mesh came onto the market in the early 2000s for prolapse repair and bladder support. Even after thousands of reports of adverse affects, repeated alarms by health advocates, and multiple lawsuits, these implants are available because they were grandfathered in under a loophole in the law. No testing was required.
- Lap-Band adjustable gastric bands went through minimal testing prior to being marketed, far less than necessary for new drug applications. According to the single study on which Lap-Bands approval was based, "Of the 299 people in the study, 51 percent reported nausea, vomiting, or both, and 25 percent had their bands removed before the end of the three-year study because of complications or failure to lose enough weight."
- Metal hip implants were cleared by the FDA without clinical testing based on “substantial equivalence” to earlier devices, though such metal-on-metal hips had long been on the agency’s high-priority list for requiring advance clinical trials. "In August of 2010, DePuy recalled all 93,000 ASR XL hips worldwide after it became clear that the device was failing far more often than average and producing serious injuries. While it’s unclear how many people actually have had to have their artificial hip removed, an article in the British Medical Journal called it 'one of the biggest disasters in orthopaedic history.' "
According to Consumers Union (the advocacy portion of Consumer Reports), the FDA needs to make changes to protect patients from unsafe medical devices and recommends that the following guidelines be instituted:
- "Require that implants and other “life-sustaining” devices be tested at least as rigorously as drugs.
- End the practice of “grandfathering” high-risk new implants and life-sustaining devices.
- Create a “unique identifier system,” or IDs for implants, so that patients can be quickly notified about recalls and safety problems.
- Create national registries so that problems can be spotted quickly and patients notified.
- Increase the user fees paid by manufacturers for regulatory review so that the FDA has enough money to do its job."
Patient safety seems to be a relatively unimportant element in the current system regarding the approval of medical devices. If you have concerns a medical device, please contact your physician immediately.
About the author:
Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year". He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.
Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.
If you have any questions about your legal rights, please email Mr. Zambri at email@example.com. You may also reach him at 202-822-1899.