FDA Considers Safety of Tools Used in Women’s Organ Prolapse Surgery

F. A. KelleyDefective Medical Devices

Organ-Prolapse

The Food and Drug Administration (FDA) says that the instruments used to place surgical mesh during some women’s surgery procedures should be subject to stricter requirements to be sure the tools are safe and effective when used in surgery.

The FDA turned to an expert panel—the Gastroenterology-Urology Devices Panel of the Medical Devices Advisory Committee—for advice about whether to move these tools from the lowest-risk category to class II, the category that means an intermediate risk of harm.

The tools in question are used to place medical mesh devices that treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI). These conditions occur when an organ such as the bladder drops from its normal place in the lower belly and pushes against the walls of the vagina. POP and SUI happen when the muscles that hold the woman’s organs in place get weak or stretched from childbirth or surgery, WebMD says. The woman can have pain, bladder and bowel problems, and painful sexual intercourse. A transvaginal mesh, or pelvic mesh, device can be implanted to provide support to the organs and remedy the problem.

But many women experience problems with the mesh devices, including pain, infection, and bleeding. The mesh can become embedded in other organs. Sometimes the mesh implant makes the original problem worse not better and many women have needed additional surgery to remove the mesh or correct the problems it caused. Thousands of women have filed lawsuits against the makers of mesh devices over their injuries, according to Medscape.

Some of the injuries reported to the FDA seem to have been caused by problems with the surgical tools. Forty-five reports involved a device fragment in the patient; in 10 reports, a piece of material that could not be absorbed 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.

The FDA panel agreed that the surgical tools should be upgraded to class II. The committee said the devices should be subject to special rules requiring manufacturers to provide reasonable assurance that the tools are safe and effective. Manufacturers must give the FDA performance data to show that the tool functions properly over its whole shelf life and that it performs as intended in the expected conditions of use. The panel agreed that the surgical tools should be under stricter regulations but panel members also said they thought most of the injuries were due to poor surgical skill. Panel members called for more guidance and training for doctors who perform these operations.

The FDA will make a final decision about whether to move the surgical tools to class II after considering the panel’s recommendations, the available evidence, and public comments it has received, Medscape says.