Report: FDA panel wants more extensive data, quality of life outcomes for vaginal mesh products

Longer, more extensive studies and a focus on subjective quality of life outcomes were among the top agreed upon recommendations for future trials studying transvaginal mesh implants used for treating pelvic organ prolapse, according to a MedTech Dive report covering the recently held FDA transvaginal mesh advisory panel.

While the panelists didn’t vote on any specific questions, they did stand behind vaginal mesh products being offered as an option to women with pelvic organ prolapse, with a particular focus on women who are not good candidates for native tissue repair, according to the report.

The group agreed that improvements were needed, both in depth and length, for both premarket and postmarket studies of the devices, MedTech Dive reports. Premarket approval studies should follow patients out to at least 18 to 24 months, while postmarket studies should follow patients to five years, the panel agreed.

Trial endpoints should compare superiority to native tissue repair at 12, 24 and 36 months as compared to the general population, while non-inferiority would be required as compared to outcomes in women who have failed native tissue repairs, according to the report.

A focus on subjective quality of life scores should also garner more attention, as pelvic organ prolapse is a non-life threatening condition, the panel agreed. In addition, women should be informed that the implants are not expected to be durable beyond 10 years, MedTech Dive reports.

Each consensus was not unanimous, according to the report, with dissenting voices concerned over the viability of extensive long-term studies and confounds including skill gaps between research surgeons and the general population.

Criticism of the FDA’s Media Device Reports system were also brought to light by former FDA UDI external program manager Madris Tomes, who now runs adverse event analysis company Device Events, MedTech Dives reports.

In a presentation, Tomes identified features of the FDA’s Manufacturer and User Facility Device Experience database that allow manufacturers to disassociate harm from device problems and submit summary reports that can include a number of patient complaints but only count as a single adverse event case, according to the report.

Experts and patient advocates were also critical as to whether companies’ postmarket 522 studies, which in nature fall short of data generated from gold-standard randomized, blinded studies, could provide appropriate data to support clearance of transvaginal mesh devices, according to Medtech Dive.

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