by Stephanie Beasley
Posted in FDA Week, June 27, 2013
FDA’s launch of a new registry for controversial surgical transvaginal mesh products as part of a new program focusing on women’s health could signal the agency is planning to prioritize sex-specific device concerns, a consumer advocate said. However, sources said it is still unclear how FDA will tackle other women-specific issues, like a lack of women in device clinical trials, and suggested the agency could examine criteria used to exclude subjects from clinical trials that could be reducing the number of women able to participate in these studies.
FDA device center officials announced Tuesday (June 25) during a two-day workshop for the Improve the Health of Women program that the agency plans to launch a new transvaginal mesh registry that will monitor patient outcomes and collect data on the safety and effectiveness of the products. The agency partnered with the National Institutes of Health, the American Urogynecological Society and the American College of Obstetricians and Gynecologists on the initiative, which will begin enrolling patients later this summer.
“I’m happy to announce that the registry is ironing out its final kinks and will register its first patient in August of this year,” said Colin Anderson-Smits, an epidemiologist at the Office of Surveillance and Biometrics in FDA’s device center.
The Pelvic Floor Disorders Outcomes Registry will begin by collecting information on pelvic organ prolapse (POP) devices but could expand to other types of mesh products, he said. Enrolled patients will be contacted by the system every six months to complete patient-reported outcomes. The registry will also collect real-time safety reports.
Transvaginal mesh, which is used to repair weakened or damaged tissue, was approved as a class II low-risk device but an advisory panel recommended FDA upclassify the products in 2011 after the agency received a number of adverse event reports citing serious complications. The panel also said FDA should require manufacturers to conduct post-market studies of currently marketed products and pre-market studies for new transvaginal mesh products.
A consumer safety advocate called the registry “a step in the right direction” toward prioritizing sex-specific device concerns but said she was concerned that it will only collect data from new patients and not those already using the devices.
“If they start with new patients, it will take years before we get the information that we need,” said Diana Zuckerman, president of the National Research Center for Women & Families.
Data from new patients will allow researchers to have better information about the patient’s health before the device was implanted, which can be compared with later outcomes from the procedure, she said. But the registry would generate information about possible health outcomes much sooner if patients already using the devices were included in the registry. It will be at least five years before there will be any useful information from the registry, she noted.
Further, Zuckerman said she was concerned that no consumer safety or public health advocates had been asked to weigh in on the design of the registry.
“The fact that we were not included suggests that consumer groups and public health groups probably weren’t asked to participate,” she said.
Stakeholders said they would also like the new women’s health program to address the lack of pre- and post-market data for women in device clinical trials.
One researcher said strict clinical trial criteria for orthopedic devices that excludes patients over a certain body mass index could be detrimental to obese women seeking more orthopedic surgeries, and who are also at greater risk for complications and poor outcomes.
Nancy Lynch, founder of the consultancy service Advisorthopaedics Inc., said although women are more likely to undergo orthopedic procedures, and twice as likely to receive joint replacements as men, they are being excluded from clinical trials for the devices because of rigid exclusion criteria like body mass index.
Obese people are at greater risk for adverse events resulting from orthopedic surgeries and generally experience fewer long-term benefits from the devices, she said. That risk has been mitigated by using BMI to exclude patients from clinical trials, but by doing so researchers are also excluding large numbers of women and and some racial groups like blacks and Hispanics.
“Eighteen percent of women have a body mass index of 35 and greater and only 12 percent of men do,” she said. “Let’s overlap race on top of that. Twenty-nine percent of African-American women would not qualify for a trial. That’s pretty significant.”
Lynch said although body weight should be a consideration for orthopedic device trials, overweight patients are more likely to have musculoskeletal conditions like arthritis and utilize orthopedic devices more frequently. Obese patients seek orthopedic treatments ten years earlier and undergo joint replacement surgeries seven years earlier than patients of normal weight, she said.
Lynch also said women of childbearing age are underrepresented in orthopedic device trials because of restrictive, long-term imaging requirements, which is a concern because 43 percent of the U.S. population is between the ages of 21 and 44 and women make up half of that number.
Zuckerman, who has long pushed for the inclusion of more women in clinical trials, said the issue was another example of how FDA has lagged behind other federal agencies like NIH that already require diversity in clinical trials. FDA should require the inclusion of women, people of various ages and obese people in these studies, she said.
“This is a bigger issue, ” she said. “It’s an issue of FDA being reluctant to require the kind of diversity that they need in these trials. FDA needs to be forceful and clear about who they expect to be in these clinical trials.” – Stephanie Beasley