Transvaginal Mesh Recall

 In Personal Injury

woman pain​Transvaginal Mesh or “TVM” was supposed to be an easy fix for women with incontinence or Pelvic Organ Prolapse (POP).  However, in many cases it has turned into an ongoing nightmare. There have been nearly 70,000 lawsuits filed by women nationwide over severe complications from their TVM product.

Our partner, West Palm Beach attorney Joe Osborne, is at the forefront of the TVM lawsuits.  He has 3,000 cases in process already.  Right now 200 of them are being handled right here in Palm Beach County, Florida.  Osborne recently won a $26.7 million verdict for four South Florida women against Boston Scientific.  Boston Scientific was the first company to market the vaginal mesh. The five other major manufactures of vaginal mesh are: American Medical Systems, C.R. Bard, Coloplast Corp., Cook Medical Inc. and Ethicon Inc. (Johnson & Johnson).

With this number of lawsuits being filed and this many injured women, the question remains, have all vaginal mesh products been recalled? Surprisingly, the answer is no.

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The FDA and Transvaginal Mesh

In January of 2012 the FDA issued a post-market surveillance study order to all manufacturers that produce the vaginal mesh products. Once these orders were issued several manufacturers removed their TVM products from the market. However, there technically has not been any official “recalls” made by the FDA or any of the manufacturers. This means there are still mesh products that are being used today.

The unfortunate issue with TVM is that the FDA did not require the manufacturers of the products to conduct any studies on humans before they were put on the market. This is because it was similar to the mesh used for hernia repairs in the abdomen. The difference between the two areas in the body is that the vagina is a warm area, collects yeast, and is susceptible to bacteria.  This makes the risk of mesh erosion far more likely. Another issue with the vaginal mesh market is that most of TVM products were based on Boston Scientifics PhotoGen mesh. This was the first mesh product pulled from the market as far back as 1999!

What is Transvaginal Mesh?

Most transvaginal mesh products are made out of a plastic called Polypropylene. These “hammock –like” mesh products are inserted through the vagina to help support weakened pelvic organs. There are two common conditions some women suffer which are often caused by childbirth. The first is Stress Urinary Incontinence (SUI) and the second is Pelvic Organ Prolapse (POP). The mesh “hammock” was designed to help support the weakened organs and lessen the symptoms of the two conditions.

The problem with mesh is that it does not behave the same in the abdomen as it does in the lower groin and vagina.  It actually erodes when placed in this area of the body. The mesh device will gradually move through the vaginal wall and could even move into the surrounding organs causing more damage rather than healing and it creates terrible life altering complications.

Transvaginal Mesh Complications

The major contributing factor to TVM complications is movement and erosion of the product. When the mesh product moves through the vaginal walls it is terribly painful, it causes heavy bleeding, has a high risk for infection, creates nerve damage and causes painful intercourse. Worst of all the mesh can actually cause organ perforation. These conditions can require several additional surgeries to repair the damage done by the TVM and to attempt to remove the vaginal mesh all together.  That word “attempt” is accurate.  There are many women who will have their mesh floating in them for years. In some women the product has degenerated to the point that doctors can’t remove it fully!

Keep in mind, the mesh was designed to stay in the body indefinitely.  There was never a solution contemplated for removing the mesh.  The mesh is designed to utilize the blood vessels and organ tissues which grow around the mesh. This makes the mesh an exceptionally difficult product to remove.  It imbeds itself in the body and the Urogynecologists (the surgeons) are forced to try and remove it in small pieces…one surgery at a time.  The process is time consuming, costly, painful and it never completely removes the mesh.   

TVM Lawsuits

With nearly 70,000 lawsuits filed, we are part of a group of attorneys specializing in TVM.  Joe Osborne and our firm will do everything we can to maximize the compensation for our clients. The lawsuits being filed include compensation for things such as:

  • Loss to their quality of life
  • Loss of wages
  • Pain and Suffering
  • All medical expenses (including the costs for any additional surgeries)

Complications from a transvaginal mesh can be devastating to a woman and her family. If you are suffering from your TVM product please don’t hesitate to call us at the LaBovick Law Group. By way of background, attorneys Esther LaBovick and Joe Osborne have been friends since childhood when they went to school together growing up in Broward County, Florida. Through their lifelong friendship Esther’s partner and husband, Brian LaBovick created a partnership in TVM cases with Joe Osborne.  Let our team work together to bring your case to justice. We want to help you get the compensation you deserve.

Image courtesy of Ohmega1982at FreeDigitalPhotos.net 

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