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Vaginal Mesh Implants get Updated Warning from the FDA

5 comments

Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue (specifically in pelvic organ prolapse (POP) or stress urinary incontinence (SUI)). It is made from either porous synthetic material or biologic material.

In 2008, the FDA issued a Public Health Notification stating that the issues with the use of synthetic vaginal mesh was a growing concern. However, on July 13th, the FDA updated the previous Notice with an Alert stating that serious complications associated with surgical mesh for transvaginal POP repair are not rare. In fact there are now reports of thousands of complications from the mesh, with at least 10 deaths being reported.

The mesh product is implanted during surgery to repair POP and SUI. The synthetic mesh has edges that are in some cases piercing the surrounding tissue and puncturing the bladder, uterus, or bowel. The “patches” can also migrate doing irreparable damage as they move around. Women are also suffering horrible infections because of the mesh.

These types of mesh underwent virtually no safety review by the FDA or any other regulatory agency before being put on the market by manufacturers. Once the mesh is implanted it is very difficult to remove. Even after multiple surgeries doctors are sometimes unable to remove all of the mesh which by that point has become infused to the surrounding tissue.

The injuries that women are suffering from this mesh implant are severe and debilitating and could have been avoided had people had the proper information. There are other safer alternatives to synthetic mesh (biological mesh for example) that should be considered before the decision is made to use synthetic materials.

Sometimes these injuries can take years to develop after the initial surgery. In 2010 there were at least 100,000 of these mesh implants performed.

5 Comments

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  1. Tor Hoerman says:
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    Jake – thanks for putting this together. Can you give us any more detail on the types of injuries that occur?

  2. June Thompson says:
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    I have a Vaginal infection & nothing helps otheal.What can be done to heal it. It 9is so painful.

  3. Faith Buchanan says:
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    I had mesh used to repair my prolasped bladder. I was having servere problems with my bladder and had to buy a lot of clothes to replace the ones I soaked even though I was using bladder control pads. When I was told about the surgery I was told some other organs were falling into the vaginal area. Now I get sick to my stomach a lot and headaches. When I bath, there is brown stuff floating in the water which I was told was a blood clot breaking lose. Also a stitch that was suppose to be permanent came through the skin and had to be removed. I’m in pain on my left side of my back and the right abdomenal area constantly. What can I expect from this mesh implant?

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    Faith and June, I am so saddened to read of your struggles as a result of the vaginal mesh implant. Sadly, we have heard from many woman experiencing life altering complications similar to yours. We would be happy to discuss your legal options anytime, and in the meantime, I hope you continue to find the strength to continue with your public frustration, as I truly believe that if we continue to put pressure on these manufacturers we may save more women from experiencing these same injuries.

  5. Merrilyn Holcomb says:
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    How far back did they do these? I had what was called a bladder/rectal repair many years ago. Were they using the mesh back in the 70’s? Also, I’m having problems again after all these years and now they say they have a temporary mesh device that can be used instead of surgery. It is removable for cleaning and you have to be fitted for it. Do you know anything about that?