FDA experts support the mesh option for patients, more complete data

Diving Brief:

• While urogynecologists need to be more discriminating in selecting patients for surgery and in information about the risk of adverse events, well-trained physicians should still offer women with previous organ prolapse Pelvic full range of treatment options, including transbadl implants, especially in cases where is not a good candidate for the repair of native tissue, suggested Tuesday the panel of obstetric and gynecological devices of the FDA.
• This line of thinking can leave space in Boston Scientific space and Coloplast, the two remaining companies that sell transbadl mesh products to process previous POPs. The FDA is currently reviewing pre-market applications, which is a requirement since the agency moved the devices into Clbad III in 2016.
• Nevertheless, panelists and other speakers asked how the FDA could confidently determine a benefit / risk profile for products based on data from post-market surveillance studies, also known as 522 studies, that the FDA had entrusted to manufacturers in 2012. At the time, the FDA told companies that the studies could also be adapted to support potential future LDC applications.

Insight on diving:

This was not your typical meeting of the FDA Advisory Committee: the agency's consultants did not vote on specific issues, but used them as a starting point for discussions.

Most panelists agreed that more complete random data, as well as a great emphasis on subjective results of quality of life are essential to establish safety, efficiency and an overall risk / benefit profile higher or lower devices. But how to gather this data realistically and make timely decisions remains at stake.

Among the consensus recommendations of the group of experts:

• Future studies of LDCs should follow patients for at least 18 to 24 months, after the sale the studies should last at least five years.
• transbadl Mesh procedures should prove superior to repairing native tissues at 12, 24 and 36 months when use is considered for the general population of women, but they simply prove not inferior at these times in the case of women who have failed or who are not otherwise repaired suitable candidates for this procedure.
• Quality of life or subjective outcomes must be given high priority in the badessment of patient success, as POP is a life-threatening disease; and women should be advised not to expect their implants to be durable beyond 10 years.

Since the panel last met in 2011 to discuss the mesh and the FDA has subsequently commissioned post-market surveillance studies, all but two companies have left the market and the devices have been transferred from the market. clbad II to clbad III. Clinical trial expert Rick Chappell, who also participated in the 2011 advisory committee, said he felt he owed patients who testified in 2011 "not to be here in eight years."

Chappell was among the majority of panelists in favor of longer studies. But many others pointed out the difficulties of research, including the long-term retention of patients and the fact that surgeons involved in research tend to be better trained and more experienced, resulting in success rates. patients higher than those in the general population. Ben Fisher, director of the FDA's reproductive, gastro-renal and urological division, also reminded panelists that although a 10-year study seems ideal, such long-term research does not balance not the need for the body to make timely regulatory decisions for patients.

Panellists and patient advocates questioned the extent to which 522 business surveys can serve as the bar for PMA studies. Panelist Madeline Dick-Biascoechea asked the leaders of the professional society whether the data collection currently underway would be sufficient for the FDA to make a regulatory decision.

"Since all three of you agree that we do not have enough [stringent data] to make decisions, do you think 522 completed will give us the data we need since they're not [randomized blinded controlled trials]? she asked.

Some professional groups offered support, albeit not endorsing, to the 522 data.

Megan Schimpf of the Society of Gynecologic Surgeons noted that most of the available data were obsolete devices and that, therefore, 522 results would be "the best we have for the products currently on the market," adding that "we need regular use fewer primitive trials in gynecological surgery ".

Geoffrey Cundiff of the American Urogynecologic Society said that it was "premature to say if we can judge on the basis of 522 data," citing the fact that the effectiveness and complications could be different at three years and continue to change over time.

Given the consensus around the importance of quality of life measures, practitioners recommended that physicians better badess the baseline for pre-treatment of patient symptoms and provide validated questionnaires that ideally , would be normalized throughout the urogynecological domain. The group agreed that it would be useful to include a question a few years after the procedure to find out if the patient would choose to undergo the procedure again.

At the end of the day, panelist and statistician Jason Connor expressed frustration at the lack of progress on how regulators and doctors are able to quantify risk for patients, pointing out that the big question that remains is how serious rare adverse events are for women carrying transbadl implants, a concern shared by some patient advocates.

"The panel's comments were for the most part:" We want to get as much data as possible, but we know it's hard to get it, "said Cindy Pearson, director of the National Women's Health Network, at MedTech Dive. "We still do not know how to tell women how much a devastating result will be likely … what is the probability that your life will be ruined, you would never wish to have it, you suffer every day." this one out of 1000? One in 10,000? "

"Nothing that has happened today brings us closer to that," she said.

Surveillance of women's health-specific devices will again be a focus of concern from March 25 to 26 when the FDA will bring together its panel of general surgery and plastic surgery devices to discuss bad implants.