vaginal mesh

Vaginal Mesh Implant Alert  |  National Broadcast

What our Vaginal Mesh Lawyers will do for you:

  • Our knowledgeable vaginal mesh lawyers will review your case for free and make determinations based on your medical history and symptoms.

  • If we determine that a manufacturer of this defective transvaginal mesh device was at fault, we will do everything possible to maximize your settlement.  We have an extraordinary track record of doing this for our clients and it is why we continue to be so successful in the court room.

  • *Important* You will not be a member of a class action.  You will be treated and represented as an individual.

Transvaginal mesh devices under investigation by FDA

The Food and Drug Administration is currently looking into reports of numerous complications involving the implantation of transvaginal mesh devices.   The FDA, which is continuing its investigation, released a preliminary report indicating that the mesh can cause injury in those women who have had the device implanted.

Vaginal Mesh Devices Explained

The vaginal mesh device is typically inserted to strengthen the patient’s vaginal tissue which has become weaker due to various causes, which can include pregnancy. The vaginal wall is usually a sturdy muscle that can support other organs in the abdomen, but when it becomes weakened, it can no longer carry this weight. The vaginal mesh device was intended to provide a sturdy support for those organs.

The medical name for the condition for which vaginal mesh is most routinely prescribed is called pelvic organ prolapse. It is estimated that at least 100,000 women had a vaginal mesh implant last year to correct this problem.

Complaints began flowing into the manufacturer in large numbers in 2005-2007. In 2008, the FDA sent a caution to doctors who were performing the surgery that there were numerous reports of complications, and that the doctors should warn patients of the problems associated with the implantation of the device. Even after this caution letter, the amount of complaints associated with vaginal mesh implants rose precipitously.


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The most common complaints surrounding the implantation of the vaginal mesh device include:

  • skin breakage
  • device protrusion
  • contraction of the mesh that leads to vaginal shrinkage
  • erosion of the vaginal epithelium
  • return of pelvic organ prolapse despite implantation
  • urinary incontinence
  • serious infections
  • bleeding

In addition to the FDA reports relating the complaints received by manufacturers, the New England Journal of Medicine reported on a separate study indicating other risks associated with the implantation of vaginal mesh to cure pelvic organ prolapse. The purpose of the study was to measure the benefits of two therapies for pelvic organ prolapse, which included surgical implantation of vaginal mesh, and colporrhaphy, which was the customary treatment prior to the vaginal mesh, where the surgeon would put the connective tissue of the vaginal wall back together. While the study demonstrated that on the whole, transvaginal mesh seemed more successful at arresting the symptoms associated with pelvic organ prolapse, the side effects of such surgery were much more severe. In addition, there was an inherent risk of a product defect. The study showed that in comparison to colporrhaphy, surgical implantation of transvaginal mesh led to:

  1. Nearly double the risk of loss of bladder control
  2. 3.2 % of women required corrective surgery after implantation
  3. 7X the risk of bladder perforation (puncture of the bladder by the implant)

 

MANUFACTURERS OF VAGINAL MESH

The most prolific manufacturers of transvaginal mesh products include C.R. Bard, Boston Scientific Schimmed, American Medical Supply, and Gynecare/Ethicon, Inc., a subsidiary of Johnson and Johnson.

bard  C.R. Bard’s list of Vaginal Mesh Products include:

  • Avaulta Solo Synthetic©  - a polypropylene mesh support
  • Avaulta Plus Biosynthetic©  – a polypropylene mesh with a matrix of corss-linked collagen on one side
  • Avaulta Biosynthetic©  – a polypropylene mesh with hydrophyilic collagen coating

johnson&johnson  Johnson & Johnson Transvaginal Mesh Products:

  • Ethicon TVT©
  • Gynecare TVT©
  • Gynemesh PS©

Nearly all of the above manufacturers, and their products, have already been named in litigation surrounding the defective nature of these products, and the injuries to those who have been implanted with them. Over 300 lawsuits are already on file. It is expected, based on the number of complaints, that there are thousands more women out there who have been suffering needlessly due to the faulty design of these products.

We are able to provide you with a free consultation to discuss your options, so there is no risk to you.  Call or email us today to speak with an experienced Vaginal Mesh Lawyer.

Contact Cates Law Firm

* Please note that no attorney/client relationship is created by submitting the above information. Past results do not guarantee future results.
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