FDA to Consider Reclassifying Trocars Used to Place Surgical Pelvic Mesh
Mesh News Desk, March 14, 2016 ~ When mesh kits were first developed and marketed in the U.S. in the mid 2000’s, they came complete with precut mesh and what’s known as a trocar.
What are trocars?
A trocar is a stainless steel needle attached generally to a plastic handle that resemble hooks. A capio is a needle used for transvaginal POP (pelvic organ prolapse) procedures. If you watch a video of a transvaginal mesh implant here (careful, these are disturbing) you will see the device threads the mesh and captures it at the other end in a blind procedure.
Trocars pass near arteries, nerves, tissues and organs.
A doctor will feel or palpate the anatomic landmarks to “access critical ligaments and attach anchors and other devices needed to secure the mesh,” according to the FDA.
Trocars have remained in a FDA classification with Band-Aids and wheelchairs- that is classified as unlikely to cause patient harm, even though they are used internally.
Now, the agency is considering whether to bump up the classification to class II, or moderate risk and adding special controls for the use of urogynecologic surgical mesh instrumentation designed to be used with urogynecologic surgical mesh. General instrumentation will remain in class I.
The U.S. Food and Drug Administration (FDA) has received 463 reports of instrumentation causing injury during an implant – from piercing an organ such as a bladder or urethra, to damage to blood vessels and nerves and other connective tissue, adverse tissue reaction, infection, nerve impingement, a needle detaching, and excessive bleeding. Boston Scientific (316) and Ethicon/ Johnson & Johnson (90) had the two highest number of adverse event reports, according to an FDA report.
The FDA searched MDRs (Medical device reports) it had received from January 1, 2008 to December 2, 2015, to determine those associated with urogynecologic surgical mesh instrumentation.
On February 26, the FDA convened an expert panel, Gastroenterology-Urology Medical Devices Advisory Committee Panel, to first, 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.
This is the third step of the reclassification process. The agency received public comments May 1, 2014, proposed the reclassification in a 513€ proposed order. 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 commented that urological surgical mesh instrumentation be reclassified as class III, the same as mesh for pelvic organ prolapse.
The FDA believes that the risks associated with urogynecologic surgical mesh instrumentation (accessory device) can be mitigated through special controls; and accordingly, the FDA believes class II is the most appropriate regulation for these devices.
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. “Unable to Confirm Complaint,” is the most frequent response. 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.
Interesting to note* – the FDA found that there were far more patient complaints lodged against instrumentation used for SUI mesh implants, rather than POP mesh, yet the FDA is only reconsidering reclassifying POP mesh as class III.
The FDA report notes between 1997 and 2015, there were 255 published reports outline 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, bladder perforation, rectal injury, hemorrhage, vascular injury, hematoma, nerve injury, nerve damage, leg pain, thigh pain, buttock pain, other pain, abscess, infection, cystotomy, enterotomy, blood transfusion and neurologic symptoms.
The adverse events range from less than one percent to more than 39 percent. ##
FDA Gastroenterology-Urology Devices Panel report, February 26, 2016
FDA Power Point Presentation on expert panel
Expert Panel Members, Feb 26, 2016