Doctors have been using transvaginal mesh products for years to treat conditions such as Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI).  In recent years, thousands of women have suffered severe and sometimes permanent complications from its use.  These conditions prompted victims to seek a legal remedy for damages.  The result was thousands of transvaginal mesh lawsuits filed against manufacturers of transvaginal mesh products in various jurisdictions.

Pelvic mesh products, also known as surgical mesh, is a medical “device” used to strengthen or repair damaged bodily tissues.  The product is normally made from a combination of synthetic and biological materials.  Doctors have been utilizing surgical mesh products by implanting it in women to treat various conditions.

For example, in certain urogynecologic procedures, pelvic mesh is utilized by implanting it permanently in the vaginal wall or to remedy POP.  SUI procedures also implant the product to support the urethra.

The following is a partial list of pelvic mesh manufacturers and their products:

  • AMS BioArc, Elevate, Perigee and Apogee
  • AMS Mini Arc Single Incision Sling
  • Avaulta Vaginal Meshes (Biosynthetic, Plus and Solo)
  • Bard Pelvic Meshes (PelviSoft, PelviLace and Pelvicol products)
  • Boston Scientific Arise, Pinnacle, Advantage Fit, Lynx, Obtryx, Prefyx PPS and Solyx
  • Caldera Mesh
  • Coloplast Mesh
  • Gynecare Prosima, TVT, Gynemesh and Prolift products
  • Mentor ObTape
  • Tyco IVS
  • Uretex

The Problem

Several years ago in 2008, the Food and Drug Administration (FDA) “issued a Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat POP and SUI (stress urinary incontinence).”

In response to the large number of complaints the FDA was receiving, the Food and Drug Administration conducted a review of vaginal mesh products.  Its conclusions were as follows:

  • Vaginal mesh products intended for use to repair POP involve more risks than if the patient used other surgical procedures done without the mesh;
  • less complications occurred in abdominal placement as compared to transvaginal surgery using mesh products;
  • No noticeable benefit was witnessed using vaginal mesh;
  • and although there could be a anatomic benefit from using the mesh for transvaginal surgical repair, there was no evidence of better results as they pertain to symptoms.

(Source: FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence)

In a more recent update, the FDA noted that complications from vaginal mesh were “not rare”. It offered recommendations for health care providers and patients as well as outlined the actions the FDA was taking in analyzing the use of surgical mesh for transvaginal repair of POP.

Further, the FDA stated that “erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh. Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication.”

The study also concluded that mesh contraction (shrinkage) was now considered a risk despite being omitted in the 2008 Notification. The report supported the notion that mesh contraction with vaginal shortening, vaginal tightening and vaginal pain were symptoms consistent with the shrinking of the product. Other complications listed in the update are:

  • Vaginal Pain
  • Pelvic Pain
  • Urinary Problems
  • Infection
  • Injury to Nearby Organs
  • Erosion of the Mesh
  • Difficulty during Sex
  • Hardening of the Mesh

A Partial Solution

The United States civil legal system protects its citizens from defective products in the form of product liability laws.  Most jurisdictions provide protection in the form of monetary compensation for defective products negligently placed in the marketplace by manufacturers.

The public policy reason for these laws is to discourage companies from releasing their products into the market without having thoroughly tested them for safety. This is accomplished by recognizing the victim’s ability to file a lawsuit for a defective condition or intentional misrepresentation of the product. These lawsuits are known as a Product Liability Actions.

Generally, three general categories exist under product liability claims for damages.  These include:

  1. Design Defects
  2. Manufacturing Defects
  3. Marketing Defects

Many women are entitled to monetary compensation through legal action against manufacturers of transvaginal mesh products if they experienced serious complications after implant surgery.

Lawsuits allege the transvaginal mesh manufacturer knew or should have known the risk of complications and they continued to market and promote the product as a safe and effective for treatment of pelvic organ prolapsed (POP) and Stress Urinary Incontinence (SUI)

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