A new investigative report represents the latest in a series of scathing reviews of the medical device industry.
The consumer media has not been kind to the medical device industry this year. A consortium of journalists released an investigative report on the industry over the weekend that blames poorly regulated medical devices for millions of patient injuries and thousands of deaths. The report, which is based on a year-long investigation by the International Consortium of Investigative Journalists (ICIJ), is the latest in a series of scathing reviews that have highlighted the darker side of medtech.
According to the ICIJ report, more than 1.7 million injuries and nearly 83,000 deaths linked to medical devices have been reported to FDA over the last decade. The journalists also point out that medical devices pulled off the market in some countries over safety concerns remain for sale in other countries.
The authors wrote that "medical implants sicken, maim and sometimes kill the very people they were designed to help," and that health authorities across the globe have failed to protect millions of patients from "poorly tested implants that can puncture organs, deliver errant shocks to the heart, rot bones and poison blood, spew overdoses of opioids and cause other needless harm."
One of the industry's leading trade association has already pushed back against the ICIJ report, arguing that it fails to look at both the challenges and the accomplishments of the industry.
“We should never discount any patient's experience. But by magnifying the stories of only a few individuals, we overlook the overwhelmingly positive experiences of millions of others," AdvaMed said in a statement issued as a response to the ICIJ report. "We take seriously all reports of patient impact, and though the medical community can never completely eliminate risk, we always strive to improve our technologies and care delivery."
The organization reiterated the reason medical device companies develop these technologies in the first place, which is to develop solutions to critical needs of patients who are often desperate for solutions.
Dubbed the Implant Files, the investigation included a team of more than 250 reporters and data specialists from 58 news organizations in 36 countries. These journalists examined hundreds of cases of medical device-related injuries and deaths from all over the world. The inquiry builds on reporting in the Netherlands by Jet Schouten, an investigative journalist for Dutch Public Broadcasting, who was part of the international team.
This is certainly not the first group to shed a troubling light on the medical device industry this year.
In May, a 60 Minutes segment brought unwanted attention to transvaginal mesh devices with a particularly harsh focus on Boston Scientific (the company spoke out about the controversial story in an interview with MD+DI soon after the report aired). The report claimed that the company made transvaginal mesh devices using counterfeit materials smuggled from China.
Boston Scientific denied any wrongdoing and received support from surgeons as well as the American Urogynecologic Society. These products, which tend to get lumped together as "pelvic mesh," are designed to treat women who suffer from pelvic organ prolapse or stress urinary incontinence. The implants are made with polypropylene resin, which has previously been linked to some patient complications. A month after the 60 Minutes report aired, a Massachusetts jury backed Boston Scientific in a product liability case involving two of the company's transvaginal mesh devices.
The next big blow to the medical device industry came in July following the Netflix release of The Bleeding Edge documentary, which offers a poignant look at specific medical device categories that have adversely impacted patients. MD+DI interviewed the filmmakers and published several pieces on the documentary, including a slideshow of the film's most powerful moments, an op-ed from a biomedical engineering expert, and a story based on reader feedback about the film.
One of the most controversial products highlighted in The Bleeding Edge is Bayer's Essure birth control system, which has been the subject of nearly 30,000 adverse event reports to FDA and thousands of patient lawsuits. Bayer announced in July that it would stop selling the Essure system in the United States at the end of the year, citing a decline in U.S. sales of the device and the conclusion that the Essure business is no longer sustainable. The company insisted that the decision to discontinue the product is for business reasons only, "not for any safety or efficacy concerns about Essure."
FDA Eyes Changes to 510(k) Program
FDA is in the process of modernizing its 510(k) clearance pathway, which was adopted in 1976 and now accounts for the majority of medical devices the agency reviews. One of the biggest proposed changes has to do with the use of older predicate devices as a means of demonstrating the safety of new medical devices. Nearly 20% of current 510(k)s are cleared based on a predicate that's more than 10 years old. That's not to say the products are unsafe, the agency said, but it does mean that some devices may not be continually improving. FDA said it will pursue additional actions that will allow the agency to retire outdated predicates, especially in cases where safer or more effective technology has emerged.
To learn more about what FDA has planned for the 510(k) pathway, click here.