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FDA Finally Reclassifies Pelvic Mesh Tools

Surgical tools, FDA

Mesh Medical Device News Desk, January 16, 2017~ Pelvic mesh tools used to place and affix transvaginal mesh had been a low-risk FDA category alongside Band-aids. Because of injuries, it’s been placed in a class II or moderate-risk category. 

Tools used to place transvaginal mesh have been found to cause injuries in up to 25% of pelvic mesh placements.

The surgical instruments include needle passers and trocars or stainless steel hooks. There are also fixation tools to affix the pelvic mesh to the tissues and anchors that are implanted deep into ligaments making them impossible to remove.

The U.S. Food and Drug Administration (FDA) didn’t think these tools presented much of a risk and had them share a class I low-risk category with Band-Aids and wheelchairs. But data shows otherwise.

Perigee System, superior and inferior needles

The MAUDE database of the FDA, that records adverse events, shows hemorrhage, bleeding, organ perforation, nerve injury and pain are all related to the use of this specialized instrumentation used in a “blind” procedure to place mesh.

That means the doctor cannot directly visualize placement of surgical mesh and must rely on tools and feel despite the fact that they pass near nerves, tissues and organs.

On January 6, 2017, the FDA reclassified these tools to moderate risk or class II, from low risk or class I. Some public comments in the Federal Register had suggested it be made to a class III high risk.

In making that recommendation, the FDA had searched its Medical Device Report (MDR) database from January 2008 to December 2015. In all it found 463 MDRs, with the most of them submitted by manufacturers, 14 by a user facility and 11 voluntary reports.

Interestingly, “The FDA then removed reports that included the terms attorney and plaintiff, as such reports typically contain few details and stem from patient litigation.”

Boston Scientific and Ethicon were the two manufacturers with the highest number of instrument malfunction problems including suture and needle detaching or breaking. Boston Scientific had 316 reports while Ethicon (Johnson & Johnson) had 90, the two highest number of adverse event reports.

Boston Scientific’s Pinnacle Pelvic Floor Repair Kit had the highest number of adverse event reports at 134 and Uphold Vaginal Support System at 167.

The reclassification of mesh surgical tools was put in the Federal Register in May 2014, the same time the FDA published a proposed order to reclassify the larger surgical mesh for pelvic organ prolapse (POP) from class II to class III or high risk.

POP mesh was reclassified beginning in January of 2016 to high–risk class III but mesh makers were given 30 months to either prove their mesh was safe and effective or stop selling it.

Just like transvaginal mesh, which is put into the moderate risk class II even though it is plastic permanently implanted in the body, the FDA had underestimated the amount of harm that pelvic mesh and its tools could cause.

Some consumer comments to the proposal suggested the surgical tools share the high risk category with pelvic organ prolapse, (POP) mesh, a larger polypropylene mesh support system.

Reclassifying requires tool manufacturers must demonstrate a reasonable assurance that the surgical instruments are safe and effective, biocompatible, sterile, and packaged correctly and safety and function as intended. Manufacturers will be required to perform tests on the instruments and label them accurately regarding their expiration date, methods and instructions, sterilization and mesh design that’s compatible with the device.

Instead, most POP mesh has already been quietly removed from the market by manufacturers, eager to avoid the future cost of thousands of defective product lawsuits.   ###

16 Comments

  1. Stopmeshimplants says:

    Finally is right. It has taken years to get to this acknowledgement by the FDA. This reclassification is something every one of us who suffers daily has known for years needed to happen. I can only wonder years from now how this mesh mess will all play out. Will the truth finally be told and will people understand how we were butchered with these mesh products by greedy manufacturers and physicians? It might be a lifetime away but I pray everyday the truth will come out and this mesh will no longer be implanted in anyone’s body. And I hope that you get the recognition you so deserve for your efforts to bring out the truth. Thank you, Jane.

  2. Andrea says:

    The FDA is timid in the reclassification of procedures and deffective products.

    The whole mesh product and technique is brutal. The vaginal and pelvic areas are compossed of nerves, muscles and tissues. To implant this crap to beging with with plastic and then do it blindly is absolutly creazy.

  3. Wish the “powers to be” had trocars skewer their groins like I had. My surgeon NEVER even gave me a clue that I would wake up from surgery with two extra puncture holes…like I had been on a rotisserie.
    I YouTubed the procedure…thought I was going to faint.
    FDA is clueless.

  4. Stopmeshimplants says:

    Exactly. I remember by doctor saying he was going to make a slight incision. If I had seen those Trocars/ hooks I would never had agreed to my surgery.

  5. MarieAnn says:

    Not told about “skewers” either! I sit here, as I type this, with a TENs unit over groin area that is forever damaged from mesh TOOLS and polypropylene. Nothing relieves the pain completely… always there since 2009!

  6. Still Standing says:

    Go figure never told me what the surgery would entail. I had four punctures with posterior and anterior. The arms that were punched through my butt were placed too high. 8 weeks later, I had tissue necrotizing because the severe muscle spasms resulted in no ozygen getting to the tissues. I asked my implant doctor exactly what was done there. She said” you don’t want to know, but what we used looks somewhat like a knitting needle”. Yes, I really did want to know preferably before the surgery. I was never told that this would be poked through muscle. I still have occassional severe pain in those two places. I’ve named them Nancy, after my implant doctor, who truly is my personal,pain in the ass.

    • Kitty says:

      Thank u for your post SS. The surgical truth is so gruesome and the injuries seem so evident ..but yet….when one goes in to see the urogyn they blame it on post menapause or constipation or arthritis or blah blah blah. They mock u
      Someday the names will come out…but not yet.

      .
      .

  7. JB says:

    How many surgeons covered these useless, dangerous instruments up? Probably most as the ones who implanted the awful mesh! That’s probably what happened to me with my injuries.

  8. lordhelpus says:

    I still have the anchors still in me which the Dr says are too dangerous to remove because this procedure was supposed to be a permanent, one shot deal….in the meantime I feel them stabbing me constantly….this pain is unbeatable. I pray the Lord touches the hearts of the judges and jurors and allows them to feel our pain in their hearts, and makes every guilty party pay for all the wrong doing, in Jesus’ name I ask, Amen.

  9. lordhelpus says:

    I meant to say this pain is “unbearable” not unbeatable. Sorry!

  10. jade says:

    Yep – I recall my doctor saying the surgery would be minimally invasive – that’s NOT true by the way and there would ONLY be 2 little incisions in my vagina! I later found out that he was referring to the two little incisions as the minimally invasive part – but, the surgery was in NO WAY minimally invasive! What a great marketing job – And, yes my implanting surgeon rides to and from his new position in a private limo – each and every day!

  11. jade says:

    Fact. No apology necessary as I’m sure not all of them are doing this. But, this fact is really irritating to me, personally. This is not to suggest he has a good life – just to keep the public informed of what “they” are doing now.

  12. JB says:

    Drs. implanting this hell mesh sure weren’t afraid to take money for wrecking people’s lives were they? I sure haven’t seen any remorse, regret from any of your drs. out there. When my 2 surgeons knew I was destroyed they just looked at me and said nothing. I guess they were preoccupied with their bank accounts.

  13. jade says:

    Yep. I wonder what my implanting doctor thinks about everyday riding in that limo – back and forth, back and forth, back and forth – has he “escaped” the punishment for his crimes? And, believe me, he implanted alot more women than me! How do we find out how many women where injured by our doctor along with us?

  14. Dottie says:

    So glad they are finally reclassifying ,Seems it will take another 10 years or so to get it to High Risk where it belongs.
    How do we ever trust doctors again.

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