FDA Orders Manufacturers to Study Mesh Complications

Jan 5th, 2012 | By | Category: Media Reports

Prolene mesh

JANUARY 4, 2012 ~ Bloomberg reports that the Food and Drug Administration’s division that oversees medical devices has ordered surgical mesh manufacturers to study how often synthetic mesh harms women by causing infection and organ damage. (story is here)

The order follows an FDA report last summer of a five-fold jump in the number of deaths or injuries and complications in women implanted with transvaginal mesh for incontinence and pelvic organ prolapse (POP). Thirty-three manufacturers of urogynecologic  surgical mesh for pelvic organ prolapse, and 11 makers of mini-slings used for stress urinary incontinence were sent letters from the FDA January 3, including Johnson & Johnson and C.R. Bard.

The makers must collect data for three years on the safety and effectiveness of the permanent medical device implants.

With about 300,000 synthetic implants used in U.S. women in 2010, the unusually high complication rate, which is largely unknown, has sparked hundreds of  lawsuits against manufacturers as well as greater questions about the FDA approval process, known as the 510(k), that allows mesh to be marketed without any safety clearances or clinical trials.

Presently, the manufacturer need only claim its medical device is equivalent to a device already on the market. But in the case of today’s synthetic mesh, the so-called predicate device, Boston Scientific’s ProteGen sling, was removed from the market over safety concerns in 1999.

The FDA has no system in place to spark a review of the devices that named it as a predicate.

The letters ask each manufacturer to determine whether a vaginal surgery, called transvaginal, where a cradle-like mesh is threaded through the pelvis, provides any benefit over a traditional surgical option without mesh.

In response to the FDA letter, Johnson & Johnson spokesman, Matthew Johnson, told Bloomberg in an e-mail,

“Ethicon’s transvaginal mesh devices are already among the most studied devices on the market, and we will continue to support their use in surgical repair with clinical evidence, through investigator-initiated and company-sponsored trials.”

Johnson has never returned the numerous phone calls from  Mesh News Desk requesting to see those studies.

The request is in response to the growing number of patient complaints and vocal patient advocacy groups who believe this revelation finally requires companies to tell the truth and not just public relations spin.

Last July 13, the FDA issued a Safety Communication that warned consumers and health care providers of a range of complications from mesh such as erosion, infection, perforation, mesh shrinkage among other problems. And it stated:

“Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than tradition non-mesh repair in all patients with POP and it may expose patients to greater risk.”

An expert panel gathered by the FDA last September to consider a recall, recommended transvaginal synthetic mesh be reclassified as “high-risk” which would required patient safety clinical trials by the manufacturers.

Bloomberg reports the requests also went out to Endo Pharmaceuticals Holding Inc., of Chadds Ford, Pennsylvania, and Boston Scientific of Natick, Massachusetts.  They have 30 days to respond.

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9 Comments to “FDA Orders Manufacturers to Study Mesh Complications”

  1. Liz Reece says:

    Thank you for publishing this, Jane.

    I feel that this reports a move in the right direction, but I still don’t understand why mesh tapes for SUI are not included in the investigations – it’s the same nasty, plastic, shrinking, leaching, eroding stuff as used in the POP, just used in smaller quantities.

    You are a remarkable force for good, Jane, and I know it must be difficult handling all this – but it’s wonderful that you do.

    Liz

    • Jane Akre says:

      Liz- They are included. I’m publishing the list and letters in the next entry in the FDA category…! You are right if the FDA is taking this seriously, they are obviously not looking at just one use. Good move in the right direction!

    • Amyg says:

      I also find it disturbing how quick surgeons are to point out that the July 2011 warning only applied to the mesh for POP and did not apply to SUI. Mesh for SUI was included in the 2008 warning.

      I guess surgeons need to hang on to their weapons of mass destruction…THE POLYPROPYLENE MESH SLING…in the war against incontinence.

  2. Jane Akre says:

    What’s missing notably is hernia mesh!

    • Amyg says:

      It seems the mesh for slings included only the newer mini-slings for incontinence and not the retropubic placed or transobtuator tape.

      • Amyg says:

        at least that is how I read the request for more studies on complications…as the FDA request did not include a request for information on the older models TOT and retropubic. It would be awesome if I am mistaken and the request for more complication info included these other slings too.

  3. Dear Jane

    I have tried for over 4 years to get the Medicine and Health Regulator in the United Kingdom to look into the problems with these medical devices but this has been to no avail.

    I am taking a petition to Number 10 Downing Street 26 January 2012 to hand over to the Prime Ministers Office on behalf of our group in The United Kingdom and will be having talks later that day in Houses of Parliament with my Member of Parliament about these mesh medical devices.

    There seems to be movement in America about these mesh devices but in the United Kingdom no one has been taking any notice of us. Let us hope we can get some movement in The United Kingdom.

    Regards Teresa Hughes.

  4. Ed says:

    I am glad that mesh is getting to see the LIGHT OF DAY for the enemy within that is truly is.

    I am a 50 year old male who was in perfect health 2 years ago before having an inguinal hernia repair with mesh . I had a previous repair about 25-30 years ago WITHOUT MESH and it healed without a trace or evidence it ever occurred.

    After going to the doctor for what i thought might be a hernia I was told that I did have one even though I NEVER SAW A BULGE like I did in the first one. I had this one repaired thinking it was not a BIG DEAL since nearly 750,000 are performed every year and i had no complications with the earlier surgery. I was given a brochure from a company called Kames or Krames which prints brochures for many surgeries to give the patient the information they need to make an “informed” decision.

    It said there were risks but that they were small and complications were “rare”. List of possible problems included infection, rejection of the mesh, nerve damage, loss or damage to testicles but once again it was emphasized that these were RARE.

    So I had the surgery a little over two years ago. since then I have had loss of feeling from the incision down towards my gentials. The doctor ytold me it should come back. Guess what?? It NEVER DID. Four months after the surgery I notice the incision is opening up on one end and a clear liquid is oozing out. I immedialtely call the doctor who of course was out of town; speak with his partner who says he can give me antibiotice to prevent infection but that I should wait till the doctor returns since he did the surgery. A few days later it closed up on it’s own. Then about 3 weeks later I have this burning/stinging sensation at the incision site.. I call the Dr. and he says it’s just a clogged pore, put a heating pad on it!!! I know my body and that is no clogged pore. The pain worsens and after 3 weeks I decide to go see a dermatologist since it is a “skin issue” allegedly. The dermatologist examines me and says it is a suture being “spit out” by my body but it is on the surface of the skin so he can remove it easily.

    A month later, I start having severa abdominal pain after eating and drinking. After a week I go to the ER where they do a CT scan. They said my stomach is fine but my bladder is almost full. How long ago did I go to the bathroom??

    So they ask if I can go again and I say yes. I come back and the Dr. rubs this jelly on my pelvic area and does an ultrasound. He says I still have almost a liter still in my bladder and he recommenda a catheter. I decline the offer and follow up with my urologist at their recommendation who examines me and says my prostate is slightly enlarged and that’s causing the problem so he put me on a medicine to help me pee more which helps but the side effects are UNBEARABLE. So I stop the medicine. Then go to get all this checked by another docotor or two to get another opinion.

    The other urologist says my prostate is not that big and he doesn’t think it’s the problem. so they do a cystoscopy and urodynamics tests all of which come back normal.

    I had another surgeon examine my hernia repair and he said he didn’t see anything wrong. The pain I’m having is due to scar tissue and hopefully it will soften up. I ask him about removing the mesh and he says he does not recommend it.

    Fast forward to May 2012 and now I have a NEW PAIN which emanates from my inner thigh and pulses into my genital area. I have been back to the orginal surgeon who referred me to a pain clinic. I obtained an updated pelvie CT scan which tsays there is a seoma and when I asked the surgeon he says that is perfectly normal and what he expects after this operation. It also says there is mild thickening around the inguinal ring. And an MRI I had for a growth that mysteriously appeared in my right hip showed mild circumferential bladder thickening.

    This does not sounds good to me. Now I have to go to a urologist and see what is going on with my body.

    If anyone wants to start protesting or getting involved with our government and speak at a hearing please let me know. I am very PASSIONATE about this issue because it has adversely impacted my life and now all I seem to be doing is going to one doctor or another.

    E-mail is: AutumnMyst2112 at yahoo dot com

  5. Linda Dodson says:

    I had the Gynecare Gymenesh PS and the FDA did investigate my 27-page complaint letter that I provided them back in February 2007. In fact, they did in fact issue a FDA-483 Observation Report for violations for failure to conduct post-market surveillance on Gynecare Gynemesh PS. I’ve got the investigative report in my sweet little hands!!

    As I said in my complaint letter to the FDA…….”The FDA is broken!!” Unless the FDA holds their employees accountable for their jobs and the industry accountable for bad medical devices, then nothing will ever get fixed. I have zero trust in the FDA and their system!!!

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.