The history of medical device regulation in the United States has been shaped by the prominent failure of individual devices, many of which were indicated for women.
The Dalkon Shield intrauterine device infamously ushered in the 1976 amendments to the Federal Food, Drug, and Cosmetics Act, establishing the first pre-market notification and approval process for medical devices in the United States. Similarly, a series of failures among devices designed for women’s health—including the power morcellator, the Essure System, and pelvic mesh—has recently invigorated the FDA’s focus on its post-market regime.
Specifically, the FDA has begun piloting a data-driven post-market surveillance system called the National Evaluation System for Health Technology, or NEST. NEST will apply analytics to real world data collected from consumers, hospitals, manufacturers, and providers with the goal of identifying and addressing risks more rapidly. The FDA’s position on NEST suggests that the agency sees a particular relationship between devices designed for women and its goal to create a post-market safety net.
Former FDA Commissioner Scott Gottlieb, in a statement on the FDA’s Medical Device Safety Action Plan, noted that the FDA was “focusing on addressing clinical questions on device therapies that are unique to women, such as treatment of uterine fibroids, pelvic floor disorder, female sterilization and long-acting reversible contraception.”
Gottlieb also elaborated on the FDA’s plan to develop a women’s health coordinated registry network to help strengthen NEST, and he stated that the agency allocated part of its $3 million NEST grant towards evaluating technology designed for women’s health. The Commissioner’s announcement also highlighted a program to collect data on the risks associated with breast implants—an initiative with new relevance in light of recent news about the agency’s decision to leave textured implants on the market.
The reasons for the FDA’s particular interest in monitoring devices designed for women’s health are likely manifold. Of course, manufacturers probably design more devices for women than for men, but the FDA may also be responding to a history of regulatory neglect. Indeed, Gottlieb suggested as such in a statement on the inclusion of women in clinical trials, noting that “years of neglect of these issues, and at times ignorance of them, have left us with disparities when it comes to the delivery of healthcare.”
Some scholarship suggests that under-regulation by the FDA has allowed manufacturers to put higher risk products on the market. An analysis of punitive damages in tort litigation found that women were more likely than men to be injured by medical devices. The study further noted that almost half of all punitive damages awarded to women stemmed from products over which the FDA has jurisdiction. The researchers specifically pointed to inaction by the FDA as one reason why manufacturers might continue to design products that bear an insupportable risk of harm for female patients.
While the FDA’s focus on post-market surveillance may correct some of this history, an approach that focuses on real-world data raises some questions about how the agency chooses to allocate risk. Post-market surveillance makes sense where risks cannot be realistically discovered in small studies. Advocates at the FDA and in industry also believe that post-market review leaves more room for companies to innovate than the pre-market process.
However, the post-market process requires consumers to use medical devices in the face of some clinical uncertainty, and consumers may not be fully aware of or consent to their roles in this system. There remains a swirl of questions about the role of privacy and consent in the context of registry surveillance. And some within the FDA have suggested that more robust active surveillance could allow the agency to loosen premarket review in some situations—a prospect that raises much more significant concerns about consent and risk allocation.
Indeed, a review of a range of devices indicated for women’s health explored serious deficiencies in the FDA’s premarket review process. As the FDA moves forward with its focus on post-market review, the agency must examine all of these questions carefully, especially in light of its history of regulatory neglect.
Alexandra Slessarev is a 2018-2019 Petrie-Flom Center Student Fellow.