This article has been updated with comments from the FDA and from Madris Tomes.
A new investigation of FDA adverse event data has revealed that more women are harmed by medical devices than men.
The report published by the International Consortium of Investigative Journalists (ICIJ) shows that among 340,000 people whom the FDA listed as having been injured by a medical device, women made up 67%, compared with men at 33%. The FDA’s MAUDE database contains adverse event reports submitted by medical professionals, medtech companies and the public, but does not reveal a patient’s gender directly, as the FDA’s drug- and biologic-related adverse-event database, FAERS, does. ICIJ wrote its own algorithm to plumb the database, searching on terms gendered pronouns such as “she” or “he,” and adjectives such as “female” and “male.”
“It is impossible to generalize the findings about patient sex to the entire universe of injuries and deaths reported to MAUDE, but the results do serve as additional evidence of a patient-sex imbalance that experts say the FDA is not doing enough to explore,” the ICIJ report says. The consortium worked with AI experts at Stanford University on its research.
An FDA spokesperson told MassDevice in an email that the agency agrees that the public should have access to more information about reports of adverse events for medical devices.
“The platform on which our MAUDE database runs is outdated and has limited functionalities, which is one of the reasons we have pushed for funding to improve our IT infrastructure for the past several years,” the spokesperson said. “Congress recently gave us additional funding for this purpose, and we are in the process of a digital transformation to build a modern platform that will allow us to make more information readily available and easier to access.”
The FDA has also been working toward a better understanding of how medical devices perform in women and exploring unique issues in the regulation of medical devices related to the health of women, the spokesperson added. Those activities include:
- The Center for Devices and Radiological Health’s (CDRH) Health of Women Program to address the steadily growing importance of sex-and gender-specific issues arising regarding medical technology design and development, clinical and non-clinical study design, and other medical device-related matters. The program’s strategic plan is open for public comment until December 23, 2019.
- CDRH’s work with health professional organizations, patient groups and others to establish the Health of Women Technologies Coordinated Registry Network to better evaluate and monitor devices used specifically for women.
- The recent FDA Immunology panel meeting on metals in implants, which included public testimony and review of the scientific evidence about immunological responses to select metals in devices, including their impact on women’s health.
“Providing women with access to safe medical devices on the market that meet their health care needs is a top priority and we will continue to work to assure that medical devices are innovated to perform safely, effectively, and optimally in all women,” the spokesperson concluded.
The ICIJ’s work on this study is critical in identifying the treatment disparities in men and women, according to Madris Tomes, founder and CEO of Device Events and a former FDA manager.
“It has long been unclear why the FDA’s device division redacts data elements that are so vital to scientific study…age, sex, and even the outcome of the adverse event are redacted by the device division but not the drug division,” Tomes said in an email to MassDevice.
She referred to a 2013 study that indicated women had higher rates of revision surgeries for hip replacements, partially due to the size of the joint.
“But, if we are to look at allergy and autoimmune issues (presented in the FDA Immunology panel’s meeting on Metals in Implants) resulting from the metals and polymers in the hips, this could provide a second reason why the revision rates for women is higher than it is for men. It is an area where more research is necessary, and it shows the need for the FDA to un-redact fields which are so important for patients, physicians and hospitals to evaluate the safety of devices.”
The new ICIJ report is part of the Implant Files, which the consortium kicked off with a major report on medtech adverse events one year ago this week. That report referenced injuries to women by devices such as Bayer’s (ETR:BAYN) Essure permanent birth control device, and pelvic mesh, which was manufactured by — among other companies — Johnson & Johnson’s (NYSE:JNJ) Ethicon. In April, the FDA banned sales of pelvic mesh by Boston Scientific and Coloplast, the last two companies to market the device in the United States.
AdvaMed did not immediately respond to requests for comment on the report.
ICIJ has also been compiling medical device adverse event data from other countries and consolidating it on the consortium’s own website. This week, it added data from the final 20 countries.