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Transvaginal Mesh Devices

New York, New Jersey and Nationwide

The Food and Drug Administration is currently looking into reports of numerous complications involving the implantation of transvaginal mesh devices. The FDA released a preliminary report indicating that the mesh can cause injury in those women who have had the device implanted. The transvaginal 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 transvaginal mesh device was intended to provide a sturdy support for those organs.

The medical name for the condition for which transvaginal 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 manufacturers in large numbers between 2005-2007. In 2008, the FDA sent a caution to doctors who were performing the surgery that numerous reports of complications had been received. The FDA further advised doctors that they should warn patients of the problems associated with the implantation of the transvaginal mesh. Even after this caution letter, the amount of complaints associated with transvaginal mesh implants rose precipitously.

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

  • skin breakage
  • device protusion
  • 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 regarding the complaints received by manufacturers, the New England Journal of Medicine reported, in a separate study, additional risks associated with the implantation of transvaginal 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 transvaginal mesh, and colporrhaphy, where the surgeon would stitch 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:

  • Nearly double the risk of loss of bladder control
  • 3.2 % of women required corrective surgery after implantation
  • 7 times the risk of bladder perforation (puncture of the bladder by the implant)

MANUFACTURERS OF MESH:

The most common manufacturers of transvaginal mesh products include C.R. Bard, Boston Scientific Corporation, American Medical Systems, and Ethicon, Inc., a subsidiary of Johnson and Johnson.

American Medical Systems (AMS) products:

  • SPARC™ Sling System
  • Elevate® Anterior and Apical Prolapse Repair System

Boston Scientific Corporation products:

  • Advantage® Sling System

C.R. Bard products:

  • Avaulta Solo™ Synthetic Support System - a polypropylene mesh support
  • Avaulta Plus™ BioSynthetic Support System - a polypropylene
  • mesh with a matrix of cross-linked collagen on one side
  • Avaulta Biosynthetic – a polypropylene mesh with hydrophyilic collagen coating
  • FasLata® Allograft
  • Pelvicol® Tissue – (Acellular Collagen Matrix)
  • PelviSoft®Biomesh - (Acellular Collagen BioMesh)
  • Pelvitex™Polypropylene Mesh

Johnson & Johnson (ETHICON) products:

  • GYNECARE TVT Secur™ System – uses GYNECARE
  • TVT™ mesh
  • GYNECARE Prolift®
  • Gynemesh® PS
  • Prolene Polypropylene mesh

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

If you or a loved one have been seriously injured by a transvaginal mesh product, please contact the experienced attorneys at Morelli Ratner PC for a free case evaluation.

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