This summer, Professor and Director Val Leiter published two papers about women’s health medical devices: “FDA regulation of menstrual devices: Increased Innovation, Decreased Oversight, and Shifting Problems,” co-authored with then-Lecturer of Public Health Charlotte Powley and Public Health student Tsion Queen ’24, and “Signs and Symptoms: Adverse Events Associated with a Sterilization Device.” We spoke to Leiter about the FDA’s role in marketing these products and her efforts to determine whether gender discrimination influences the oversight of medical devices for women.
“Regulation often lags behind innovation,” says Val Leiter, Professor and Chair of the Department of Public Health and Director of the Bachelor of Science program in Public Health. “My question now is, does it lag for everything, or just for women’s health devices?”
The medical device industry has witnessed steady innovation in recent years. Leiter’s research focuses on the FDA’s regulation of devices for female reproductive systems, including the Essure sterilization device (implanted by a doctor), and menstrual cups (inserted by the individual without professional involvement).
Lack of FDA Oversight for Menstrual Cups
“The sustainability and price of [menstrual] cups are amazing,” notes Leiter. Because the cups are reusable, they reduce landfill waste and save the customer money — an important point, given the cumulative cost of period supplies over a lifetime.
Traditionally, tampons have been subject to greater regulation than menstrual pads, due to the fact that they are inserted internally and cases of toxic shock syndrome (which could be fatal and was potentially caused by tampon use) in the 1980s. In 2016, as a result of Congress’s passage of the 21st Century Cures Act, the new FDA regulations stated that medical devices that were “not implanted” and deemed “not life-sustaining or -supporting,” did not require FDA review before market release. Under these guidelines, menstrual cups and period-proof underwear, like menstrual pads, were not subject to FDA review.
“From my perspective, this was a mistake, particularly for cups,” says Leiter, reflecting on the research for her article, “FDA Regulation of Menstrual Devices: Increased Innovation, Decreased Oversight, and Shifting Problems.” “People are told that the cups can be inserted and left for up to 12 hours. If they aren’t regulated, then the follow-up surveillance of these devices won’t function.” This lack of surveillance is particularly problematic given that the majority of adverse event reports associated with menstrual devices over the past decade have been focused on the use of menstrual cups.
Leiter clarifies that major name brands of menstrual cups have “done what they are supposed to do,” by including on their packaging a website and a 1-800 number that users can call to report problems.
Of concern are the generic devices available, which Leiter purchased for her research via e-commerce sites eBay and Amazon. “There were FDA logos printed on the packaging, which is illegal,” she says, “and a lack of [information] that traces back to a company that produced it. If I’m going to file an adverse event report with the FDA, I don’t even know what company made this device. It’s the breakdown in accountability here that is worrisome.”
Essure device
Sterilization has become the most popular contraceptive method in recent years, edging out the birth control pill. In part, that popularity is due to sterilization devices, such as Essure, which were sold to women seeking sterilization on the basis of convenience and quicker healing.
“They were looking for sterilization, and this [device] was pitched as a more convenient option. They were told that if they got the device instead [as opposed to tubal ligation, a surgical procedure that permanently prevents pregnancy] they would be back on their feet sooner.” There were incentives for providers, too, given that insertion of a device such as Essure could be done during an office visit, while a tubal ligation required the use of an operating room and the additional time, cost, and liabilities associated with surgery.
As stated in her article, “Signs and Symptoms: Adverse Events Associated with a Sterilization Device,” patients reported feeling that their doctors didn’t give a full picture of the risks associated with an implanted device, instead referring to it as “100 percent safe and pain free.” However, the lack of information provided to patients and caregivers about the Essure device was dangerous. “Whoever does the surgery needs to go through a checklist with the patient, but the information for the Essure device was [inadequate],” says Leiter, noting that the presence of nickel in the implant was particularly troubling, as the material can create problems for patients with a nickel allergy or sensitivity.
After the insertion of the Essure device, many patients complained of pain and bleeding. However, as these symptoms are considered difficult to measure objectively, and are often conflated with usual symptoms of a heavy period, the patient’s concerns were often dismissed. “The dismissal of pain is a gendered phenomenon,” says Leiter. “Pain and bleeding [as a result of the Essure device] was normalized, and the degree of the pain and cramps the patients reported wasn’t taken seriously. With menstruation, [people experience] pain and bleeding, but it’s a matter of degrees. Pain is subjective, but I think there is a gendered component for sure.”
There is, unfortunately, an historical precedent for the dismissal of a patient’s pain, especially in regards to women’s health. A paper that Leiter co-wrote with Gracyn Delaune ’24 and presented last spring, “Reproductive Technology Redeemed?: IUDs from the Dalkon Shield to the Present,” documented that 30% of women in the U.S. who discontinued IUDs did so because abdominal pain, cramping, or back pain.
In the case of the Essure device, when patients requested the removal of the device, doctors and insurance companies often refused them. “The pain and bleeding [patients experienced] wasn’t enough of a reason to justify [a removal],” notes Leiter. “The insurance would say it wasn’t medically necessary.” Doctors told patients their bodies would “adjust” to the device. Some patients were told that the physical symptoms were emotional in nature, or “all in her head.”
Essure was on the market for 17 years (2002–2018) and had amassed a large number of complaints, which doctors were not required to disclose to patients. In 2018, Bayer, the company behind the product, pulled it from the market for commercial reasons, but did not cite safety issues. The FDA had not acted, in spite of customer complaints.
While Leiter’s interest in women’s health — including another study on why patients opted to have intrauterine devices (IUDs) removed — is ongoing, she intends to take a new approach to the subject of medical devices, as well.
“Women’s health activists are mobilized due to past reproductive health tragedies,” she says. “The history of the FDA is interwoven with these issues, including DES [a synthetic estrogen prescribed to avoid early labor that resulted in an increased risk of cancer], toxic shock syndrome, and thalidomide, which have been well documented. I don’t know to what extent it affects other devices, too.”
To answer the remaining question, Leiter’s current project involves interviewing people with surgically implanted “gender neutral” devices — like hip and knee replacements, cochlear implants, and pacemakers — to see how the results compare with women’s health devices.
Above all, Leiter urges everyone to “find a provider who will listen to you.” A primary care physician should ask about what devices you have in your body. “This is important, as some devices and inflammation won’t show up on imaging.” Also, keep in mind that an obstetrician/gynecologist will be far more informed about sterilization and menstrual devices than an emergency room doctor. “The technology is continually changing,” says Leiter. “There’s always a lag in clinical knowledge.”
Professor Leiter’s Recommendations for Consumers
- Document your implant: “If you don’t know what is [implanted] in your body–either the brand name or company –you won’t know if there is a recall.”
- Check the FDA database: “If you or anybody you love is having a device implanted, go to the database on the FDA website to search all adverse event reports and you can see if there have been any problems,” she says. The Manufacturer and User Facility Device Experience (MAUDE) Database includes information on complaints filed over the last ten years.
- Consider: how long has this device been on the market? While she notes that today’s culture gravitates toward the newest innovation, Leiter advises avoiding any device that hasn’t been on the market for at least five years. “Clinical testing is done on a limited number of people,” she notes. “Only when it’s implanted in a million people, as opposed to a few thousand, do we see some problems.”
For students interested in assisting Professor Leiter in her research, there are undergraduate fellowship programs through which students can be hired as paid research assistants. Reach out to her directly if you would like to be involved.