Stricter Manufacturing Requirements for Surgical Mesh
According to the US Food and Drug Administration (FDA), instrumentation used to place surgical mesh during urogynecological procedures should be subject to stricter manufacturing requirements and more detailed labeling.
About the New Surgical Mesh Requirements
The FDA gathered the Gastroenterology-Urology Devices Panel of the Medical Devices Advisory Committee to decide 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.
A Capio needle used for transvaginal pelvic organ prolapse (POP) procedures, instrumentation for retropubic sling placement, and instrumentation for transobturator sling placement are just a few examples according to Medscape.
After some review, the panel agreed that the surgical tools must be upgraded to class II. The panel said that devices should be subjected 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.”
Now, labels must include several things: instructions on which mesh design can be used with the tools, a detailed summary of the device's clinical evaluations, and an expiration date.
Hundreds of Devices Malfunctioned
In May 2014 the agency first proposed the stricter scrutiny. In January 2016, the surgical mesh was reclassified allowing manufacturers about 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.
Ben Fisher, PhD, director of the FDA's Division of Reproductive, Gastro-Renal, and Urological Devices said “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.”
However, manufacturers were not happy.
Dr. Fisher said that all of them would be put under the rules governing class II devices based on risks the agency identified with the tools.
Surgical Mesh Malfunction Statistics
According to Medscape, 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. It found the following:
- There were 463 reports filed with the FDA.
- 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
- Over 250 of the reports were about a detachment of a device
- 141 were for a tool breaking.
- 231 reports, 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 Associated with Pelvic Mesh
Panelist Cheryl Iglesia, MD, director of the Section of Female Pelvic Medicine and Reconstructive Surgery at MedStar Washington Hospital Center said “that training component is going to be more important in mitigating these catastrophic injuries” than FDA requirements.
Marjorie Shulman, director of the FDA's premarket notification program said 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.