FDA Panel: Urogynecological Mesh Tools Need Higher Risk Level

Alicia Ault

February 26, 2016

GAITHERSBURG, MD — Instrumentation used to place surgical mesh during urogynecological procedures should be subject to stricter manufacturing requirements and more detailed labeling, according to US Food and Drug Administration (FDA) advisers.

The FDA convened the Gastroenterology-Urology Devices Panel of the Medical Devices Advisory Committee today to seek its opinion on an agency proposal to reclassify the surgical instrumentation — from class I, which is for the lowest-risk devices, to class II, which designates intermediate risk of harm.

Some examples of the instrumentation include a Capio needle used for transvaginal pelvic organ prolapse (POP) procedure, instrumentation for retropubic sling placement, and instrumentation for transobturator sling placement.

The panel agreed that the surgical tools should be upgraded to class II. And, said the committee, the devices should be subject to special agency rules requiring manufacturers to provide reasonable assurance of the tools' safety and effectiveness. Manufacturers must prove a device is biocompatible and sterile, and must supply performance data showing that it functions over the length of its shelf life and that it performs as intended under anticipated conditions of use.

Labels will have to include instructions on which mesh design can be used with the tools, a detailed summary of the device's clinical evaluations, and an expiration date.

The FDA usually follows its panels' advice.

Hundreds of Devices Malfunctioned

The agency first proposed stricter requirements in May 2014. They were included in a proposal to also move surgical mesh for transvaginal POP repair from a class II to a class III device. The surgical mesh was reclassified in January 2016, giving manufacturers 30 months to submit a full premarket approval application with clinical data to the agency.

The mesh has been associated with numerous injuries and has been the subject of multiple lawsuits.

In many cases, surgical instruments are packaged together with mesh, which means that the FDA would be allowed to consider those particular instruments as class III, also, said Ben Fisher, PhD, director of the FDA's Division of Reproductive, Gastro-Renal, and Urological Devices. But manufacturers were not happy that some tools would be class III while others sold individually would remain class I.

Based on risks the agency identified with the tools, it decided that it would seek to put all of them under the rules governing class II devices, said Dr Fisher.

The FDA reviewed its Manufacturer and User Facility Device Experience (MAUDE) database for all medical device reports relating to urogynecological mesh tools submitted from January 2008 to December 2015 and found 463 such reports; 339 were for malfunctions and 124 for injuries. The vast majority — 186 — were related to placement of transvaginal mesh for POP.

Forty-five reports involved a device fragment in the patient; in 10 reports, a piece of nonresorbable material was left in a body. Just over 250 of the reports were about a detachment of a device, and 141 were for a tool breaking.

In almost all the reports — 231 — the manufacturers couldn't make a determination about the cause of a problem because the device was not returned for examination.

The FDA also reviewed published reports of problems with mesh instrumentation, finding a variety of issues from organ perforation to vascular and nerve injury.

Surgical Error

While the committee agreed that the surgical tools should receive stricter scrutiny from the FDA, they also said they believed the majority of patient injuries were due to poor surgical skill.

Panelist Cheryl Iglesia, MD, director of the Section of Female Pelvic Medicine and Reconstructive Surgery at MedStar Washington Hospital Center, in Washington, DC, called on the specialty societies to issue more clinical guidelines and education on mesh placement and use.

"That training component is going to be more important in mitigating these catastrophic injuries" than FDA requirements, said Dr Iglesia.

The FDA will make a final decision on moving the surgical tools to class II after weighing the panel's recommendations along with the available evidence, and public comments it has received, said Marjorie Shulman, director of the FDA's premarket notification program.


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