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FDA to Consider Reclassifying Trocars Used to Place Surgical Pelvic Mesh

Trocars

Capio, retropubic sling instrument, transobturator sling instrumentation, from FDA

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.page one

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.

judge mallet 200*Note- the FDA removed those reports that contained the terms attorney and/or plaintiff, “as such reports typically contain few details and stem from patient litigation.”

EXPERT PANEL CONVENED pop placement of mesh

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.manu comment on trocar reports

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.

 

trocars two from feb 2016 panelADVERSE EVENTS

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.  ##

 

LEARN MORE:

FDA Gastroenterology-Urology Devices Panel report, February 26, 2016

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/

MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM487224.pdf

FDA Power Point Presentation on expert panel

http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/medicaldevices/medicaldevicesadvisorycommittee/gastroenterology-urologydevicespanel/ucm490205.pdf

Expert Panel Members, Feb 26, 2016

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM487202.pdf

 

10 Comments

  1. buynowpaylater says:

    I had pop surgery and trocars were used. I felt like I had been on a

    rotisserie like a chicken…this was never explained to me and healing

    from the trocars was very painful and difficult…I hope the FDA takes

    a very close look at the classification of the usage of trocars for pop

    transvaginal surgery…but in reality I expect nothing to change from the FDA…per usual.

  2. Women harmed by surgical mesh are poorly represented by the FDA and Advisory Panels that are hand-selected by FDA/OSHI (Office of Special Health Issues). The Director of FDA/CDRH (medical devices) is Dr. Jeff Shuren. His household income is dependent upon the medical device industry, as his wife Allison Shuren is a partner of DC law office Arnold & Porter and her job is to prepare the medical device industry for FDA clearance. In addition, Dr. William Maisel (cardiologist) is deputy science director and signs off on women’s health issues: he was arrested and convicted for soliciting a prostitute, yet maintains his $250,000 federal employment.

    The ONLY job of FDA/CDRH is to protect patients from harmful devices, but there are 28,000 women harmed by Bayer Essure coils, 100,000 toxic metal on metal hip replacements and 85,000 women in federal court in West Virginia for surgical mesh PREVENTABLE harm. The FDA is a FAILURE and they are not to be trusted: they trash our civil rights without our knowledge and expect taxpayers to cover the cost of this harm-for-profit scandal.

    I am a 2010 trained FDA/CDRH Patient Representative.

    • Jane Akre says:

      Joleen- How can others apply to get on an expert panel as a citizen representative? What steps did you take?

  3. stopmeshimplants says:

    Oh c’mon now. They have to start reclassification with trocars instead of going after the mesh kits? Whatever. I think the mesh kits will follow with reclassification and someday soon these manufacturers will suffer because of all of the lives forever damaged by mesh implants. I truly believe our day will come and this news story that never happened will come to light. Thank you, Jane.

    • Jane Akre says:

      Whats interesting is that trocars, the mesh kits and instructions on how to use/place the mesh is intellectual property, therefore has insurance coverage. Why is no one seeking out that insurance coverage to add to the settlement dollars?

  4. Susan says:

    I had a large hematoma from puncturing a major vessel during implantation of J & J mesh. I also now have entrapment of my ilioinguinal nerve.

    • Bonnie says:

      Susan I also had to spend the night after having mine put in as I was bleeding lots. I was all packed with guaze and in so much pain. I have nerve pain but haven’t found out which nerve as of yet I have severe leg and under feet pain. Under my feet are like I’m walking on hot coals.

      • Kitty says:

        Jane. Why did you change your format?

      • Still Standing says:

        Have you tried medication for neuropathic pain? Gabbapentin and/or amitriptyline? It can really make a difference. I know most people have a hard time getting adjusted to these medications. However, .i found that giving my body time to adapt payed off. I felt very foggy for a couple of months,, but now have none of that. Those two meds totally changed my pain management. I am mostly pain free as far as the burning, shocks up my legs pain. One upside is that they are very cheap meds. I have a script for gabapentin that I can take more or less, depending on the circumstances. I finally settled on 100 mg of amitriptyline at night.( also helps a great deal with sleep) Have had no weight gain or other problems associated with them, but constipation can be an issue.,it was with me until I added Natural Calm at night. The magnesium keeps me pretty regular. Prior to, I needed dynamite to go. It is worth a try if you havent gone there yet. I could not take Lyrica, cymbalta or others. What has your doctor suggested?

  5. […] instruments and the doctors who use them to place transvaginal mesh, have been found to cause injuries to […]

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