Johnson &Johnson’s Vaginal-Mesh Costs May Rise If $5 Million Deal Is a Guide
April 5, 2016

FDA to Consider Reclassification of Trocars Used in Surgical Pelvic Mesh Procedures

In the mid 2000’s, when mesh kits were first developed and marketed in the U.S., they came complete with precut mesh and what’s known as a trocar. A trocar is a stainless steel needle attached to a plastic handle that resembles a hook. A capio is a needle used for transvaginal POP (pelvic organ prolapse) procedures. Trocars pass near arteries, tissues, nerves, and organs. According to the FDA, a doctor will feel or palpate the anatomic landmarks to “access critical ligaments and attach anchors and other devices needed to secure the mesh”. Trocars have remained in a FDA classification the same as Band-Aids and wheelchairs. That is, a classification that is unlikely to cause patient harm, even though they are used internally.

The U.S. Food and Drug Administration (FDA) has received 463 reports of instrumentation causing injury during an implant procedure, from piercing an organ such as a bladder or urethra, to damaging blood vessels, nerves and other connective tissue, adverse tissue reaction, infection, nerve impingement, a needle detaching, and excessive bleeding. According to an FDA report, Boston Scientific (316) and Ethicon/Johnson & Johnson (90) had the two highest number of adverse event reports.

On February 26, the FDA convened an expert panel, Gastroenterology-Urology Medical Devices Advisory Committee Panel, to define a trocar, review the 463 adverse event reports and decide whether they should be reclassified. The FDA usually follows the recommendation of its expert panels.
Convening the panel is the third step before reclassification.

The FDA received just 13 public comments related to reclassification following the publication of the May 1, 2014 proposed order. Six of those comments supported reclassification. A consumer group also commented that urological surgical mesh instrumentation be reclassified as class III, the same as mesh for POP.

The FDA believes that the risks associated with urogynecologic surgical mesh instrumentation (accessory device) can be mitigated through special controls. Accordingly, the FDA believes the most appropriate regulation for these devices is class II.

As evidence that the FDA follows the lead of manufacturers, the manufacturers are the final word on whether their own trocars contributed to the injury/damage. The most frequent response is “Unable to Confirm Complaint”. Adverse event comments made to the FDA also concerning pelvic and hernia mesh also rely on the final assessment by manufacturers as to whether their device/instrument led to the injury.

The FDA report notes between 1997 and 2015, there were 255 published reports outlining adverse events with respect to pelvic mesh surgery. This could involve a problem with the surgery including or not the type of surgical instrumentation.

The adverse events included organ perforation, injury, urethral injury, bladder injury, nerve damage, rectal injury, hemorrhage, cystotomy, vascular injury, nerve injury, leg pain, thigh pain, buttock pain, other pain, abscess, bladder perforation, hematoma, infection, enterotomy, blood transfusion and neurologic symptoms. The adverse events are from less than one percent to more than 39 percent.