16,000 complaints involving Essure – a coil-like permanent birth control device- were reported to its manufacturer, Conceptus Inc., between January 2008 and December 2010. However, during that same time period of time, Conceptus (which was acquired by Bayer AG in 2013) filed only 182 reports of patient harm with the FDA. That’s a mere 1.1%. Worse yet, 750,000 Essure implants were sold worldwide until Bayer voluntarily – no, not recalled – pulled it from market in 2018 due to a 70% decrease in sales. So how can a medical device company get away with only reporting a small fraction of complaints to the FDA? Why was Bayer not penalized by the FDA for their negligence in reporting which put hundreds of thousands of women at risk?
Problems with the FDA Reporting System
According to an intensive study conducted by the International Consortium of Investigative Journalists (ICIJ), there are three major flaws involving device companies and the process of reporting to the FDA:
- “FDA inspections have found more than 4,400 violations by device companies of its rules for handling complaints and reporting device problems in the last decade. Each violation can include hundreds or even thousands of mishandled complaints.”
- “Manufacturers and others required to report adverse events have classified more than 2,200 episodes in which patients died not as deaths but as injuries, malfunctions or other less severe events in the last five years.”
- “The FDA has allowed companies to obscure thousands of injury reports using a program called alternative summary reporting that allows them to keep the information from the public.”
Clearly there are far too many loopholes in the approval and management of medical devices that by far benefit the pharmaceutical companies at the cost of patient health. For example, it can be a grey area to determine if the device itself caused a patient death since the body can shut down at various levels. In the case of the manufacturer Thoratec Corp., a patient had a HeartMate II implant which provides circulatory support to patients with advanced heart disease. When the patient died, two suspected causes of death were reported: “suspected pump thrombus,” a device failure caused by a blood clot that blocks the pump, and multisystem organ failure. Thoratec’s report mentions the patient’s death, but cites the incident as an injury and faults organ failure as the cause of death. The obvious question here is did the mechanical failure cause the organs to shut down? One (of the many) problems is that with hundreds of thousands of complaints reported to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, it can be an insurmountable task to thoroughly evaluate each reported event. However, pump blockages were a common enough problem with this device that the FDA issued a safety warning for them in 2015.
Foreign Medical Device Companies
While there’s a laundry list of things wrong with the FDA and how it manages the medical device industry, it’s important to mention that it’s the best agency of its kind in the world. In fact, Europe’s Eudamed adverse events database is accessible only to regulators and industry professionals, in Chile reporting adverse events is voluntary, and in Mexico this data is hidden from the public. So this brings us to another problem: if the U.S. is having trouble managing its own medical device companies, how are we monitoring foreign made products?
Last year in May 2018, 60 Minutes ran an important story exposing Boston Scientific (makers of transvaginal mesh) and how they smuggled counterfeit polypropylene material from a company in China due to a shortage in the U.S. And there are many layers to this story: not only is polypropylene a fragile material that can erode, migrate, shrink and cause many painful health complications, but an unverified foreign product increases the potential for injuries. When Boston Scientific compared the U.S. approved plastic with the foreign one, this is what they found: “They analyzed 11 different parameters, looking at the two plastics side by side, done, the same tests. Nine of those were different,” cites the 60 Minutes program. “Two were the same, nine were different. And of those nine that were different, four of those parameters were very different. And somehow, from that, they concluded that it was the same material.” Boston Scientific denied all allegations, but more than 48,000 lawsuits have been filed against the company on behalf of injured women.
Do You Have a Medical Device?
Not all medical devices are bad nor are they beneficial. As patients, our job is to be our best advocate. Research your surgery procedure and potential medical device online. Visit your doctor with a list of prepared questions or email your doctors to get the answers that you’re looking for. Weigh the risks and benefits to any procedure to determine the best choice for your health. We also need to speak out against bad medical device companies and FDA loopholes… our health depends on it.