TVT-O from TVT Meshed Up, UK

TVT-O from TVT Meshed Up, UK

Editorial- Jane Akre, MND –

In July 2011 the U.S. Food and Drug Administration (FDA) issued a Safety Communication that surgical mesh used to treat pelvic organ prolapse (POP) carried more risks than benefits and was “of serious concern.”  See the notice here.

Mesh erosion can “require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication.”  Mesh shrinkage, mesh contraction, pelvic pain, painful sexual intercourse could result and these serious complications are “not rare” said the FDA, a reversal from an October 20, 2008 notice. Doctors were urged to:

* Obtain special training for mesh placement

* Be vigilant for potential adverse events especially erosion and infection

* Watch for complications especially bowel, bladder and blood vessel  perforations

* Inform patients surgical mesh implantation is permanent

* Recognize that in most cases POP can be treated successfully without mesh

Day on Notice

That day –  July 13th  – is essentially the time that the medical community knew or should have known that mesh carried with it inherent dangers “not present in traditional non-mesh surgery for POP repair.”

Why then is the issue of mesh complications still being debated?  Why then does such a divide exist between the medical community and the communication with women whom they are treating?

What has happened since July 2011?  How many patients have received full and complete informed consent since that date?  How many doctors have revealed their financial conflict-of-interest with mesh manufacturers?

On stress urinary incontinence (SUI)  mesh complications, the FDA said it would get back. That has not happened even though Mesh News Desk reported there was a 36% increase in SUI mesh complications last year.  See story here.  MND recently inquired about the updated SUI complication numbers being reported into the agency and was told an update does not exist.

And why then does the medical community still offer polypropylene mesh as a first-line treatment for POP and SUI, especially since complications are coming in about 30 percent for hernia mesh patients implanted with the same polypropylene mesh. (See background story here).   That number is difficult to assess because there is no post approval monitoring requirement for POP, SUI and hernia mesh and any complication reports are voluntary.

Instead, some doctors are telling patients they believe the mesh controversy is strictly lawyer-generated.

One survivor tells MND:

How can we all be just making this up until a settlement comes when our medical records show proof of injuries? I guess all the doctors who write this on our records are committing fraud? I highly doubt it.  I woke up crying this morning over the whole mesh issue. You see by now all the bills that are hounding me would be paid if I could work but I can’t. I have been so hurt that social security approved me the first time I applied. My medical records show without a doubt I can’t work. Most people 70-80% get denied the first time around. I am losing my marriage and everything I have worked my entire life for. I don’t know when a settlement will come or if. I don’t know how much it will be. My attorney said well if you can’t work because of the mesh then your case will be worth a lot more. A lot more than what? Can it help to rebuild my body, my marriage, my family? Today is a day that I just want to give up anymore. I am so tired of fighting. Of living like I am some kind of deadbeat just wanting a hand out.”

AUA Doctor Divide

The American Urologic Association (AUA), a professional medical organization recently met in Orlando Florida. Security was reportedly tight and obtaining pictures of the many sponsors on the exhibit floor was not allowed.  No wonder. There you would see banners from Ethicon, AMS, Boston Scientific, among others.  The mesh business is a multimillion dollar enterprise, and growing along with the aging baby boomer population.

Drugwatch’s Michelle Llamas attended the session and watched as the society debates mesh for stress urinary incontinence (SUI). The story is here.  Llamas reports AUA’s official position is: “restriction on the use of synthetic polypropylene mesh would be a disservice to women.”

So here we are almost three years after the FDA warning that mesh complications for POP were growing and “not rare,” and that SUI mesh complications were on the rise as well and we have a panel of four specialists in the field of urology debating whether mesh slings so more harm than good?

Dr. Michael Kennelly, Charlotte Continence Center

Dr. Michael Kennelly, Charlotte Continence Center

According to the Drugwatch report, the four panelists were divided in their thinking about surgical mesh slings. The debate was whether the benefits outweigh the risks and whether it’s the mesh itself or the technique of the surgeon.

Those in favor of mesh slings were Dr. Michael J. Kennelly from Charlotte NC, here, and Dr. Eric S. Rovner at the Medical University of South Carolina, here.

“Here you have a doc claiming mesh is the worldwide standard because it is minimally invasive and only takes 22 minutes. Yet his own data shows 90% of his patients complain of pain. Amazing! He can’t understand why mesh slings would be any worse than polypropylene used for hernias and sutures.”~ woman online to MND.

Dr. Eric Rovner, MUSC

Dr. Eric Rovner, MUSC

They praised the fact that a mesh sling can be implanted in as little as 22 minutes. Dr. Rovner blamed lawyers for highlighting the complications.

Dr. Jerry Blaivas, Urocenter of NY

Dr. Jerry Blaivas, Urocenter of NY

On the other side of the argument were Dr. Jerry Blaivas (Weill Cornell Medical College) here, and and Dr. Helen O’Connell (University of Melbourne, Australia) here.

Neither Blaivas or O’Connell will use polypropylene mesh. These two doctors prefer to use autologous slings taken from the patient’s own tissue to create their own sling and to use for prolapse repair as well.

“The audience was silent as Blaivas showed graphic slides of patients and the terrible complications they suffered after undergoing “one of these 22-minute retropubic slings, done minimally invasive.” One of the slides featured a patient who underwent six operations to remove the mesh, which, as Blaivas stressed, can be difficult even for the most experienced of surgeons.”~ Drugwatch

Blaivas compared the lack of knowledge about the dangers of mesh to cigarettes back in the 60’s.

O’Connell said the mesh disasters are avoidable and that sling complications are on the rise, the operations are experimental and the real complication rate is unknown and underreported.

Women should have a choice she concluded.

While doctors debate this issue and the FDA remains silent on SUI injuries, women can contribute to an open letter to be sent to the medical societies.

Open Letter –Suggested Topics

  • SUI mesh complications are real and growing
  • The FDA needs to be counting them and doctors need to be reporting them
  • Medical societies should insist complications be reported
  • Medical schools need to once again teach the traditional repair techniques and not fall prey to marketing by medical manufacturers.
  • Informed Consent should be complete and include the ever evolving realities of mesh
  • Professional medical groups (AUA, AUGS, ACOG) need to make transparent conflict of interest payments from manufacturers to board members.

Your Comments Here:

“First, there ARE problems with other applications of mesh AND there’s a difference that some male “doctors” can’t get through their heads: sexual intercourse creates friction between the delicate tissues trapped between the mesh, the penis and all of the other muscles, ligaments and bone in the pelvic region. This results in repeated trauma to the tissues especially in the tissues of post-menopausal women. Let’s face it, if there wasn’t any pressure and friction, men wouldn’t be very happy. Would they? I guess some still believe that sex is something women should accept as their responsibility to their “man” and we complain too much whether we have mesh or not.”