Transvaginal Mesh Litigation Guidelines
At least 70,000 women suffered the horrific complications of a Transvaginal Mesh implant, and many of them are filing lawsuits. The unexpected side effects of these prolapse repair devices included organ perforation, mesh erosion, excruciating pain, bleeding, and infections. Complicated revision surgeries are often the only solution to manage the otherwise unbearable symptoms.
What is a Transvaginal mesh?
A transvaginal mesh (TVM) is a special kind of urogynecologic surgical mesh made of synthetic (plastic) or other organic materials such as animal tissues. Implants made of polypropylene can be absorbed by the body and may be knitted or non-knitted. Those made with animal-derived tissues are derived from pig or cow intestines or skin that have been sterilized and processed. A non-absorbable surgical mesh is introduced through the vagina to contain and support damage or weakened internal tissues indefinitely. Absorbable meshes will slowly degrade over time, and are used to provide a local short-term reinforcement until new tissue grows. Both these types of implant are used to fix some of the consequences of childbirth or hysterectomy such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Why is this device dangerous?
In 2011, the U.S. Food and Drug Administration (FDA) conducted a systematic review of the scientific literature published in the last 15 years to evaluate the effectiveness and safety of surgical mesh. Between 2008 and 2010, in fact, the regulator received almost 3,000 adverse event reports of complications associated with these devices, more than triple than those reported in the previous 3-year period. The investigation concluded that using a mesh for POP and SUI repair introduced a new risk of serious complications that weren’t otherwise present in non-mesh surgical repair operations. These side effects included pain during sexual intercourse, mesh erosion, neuro-muscular disorders, vaginal scarring, and organ perforation.
The mesh can erode and pass through the vaginal muscles, where its jagged edges can protrude outside (exposure) or cause pain, infection, and bleeding. In some instances these sharp edges perforated nearby organs, including the bladder, causing serious or permanent damage. Many patients also required multiple surgical interventions to manage the complications of TVM implant. The regulatory agency also didn’t found any convincing evidence that the use of this device added any benefit to traditional surgery, and neither provided symptomatic relief to the women who were implanted with it. In 2016, the FDA increased the risk class of surgical mesh from moderate to high-risk.
Transvaginal Mesh Multidistrict Litigation
More than 70,000 transvaginal mesh lawsuits are pending in courts all across the country due to the impressive number of injuries reported so far. To speed up proceedings, the litigations have been centralized in several Multidistrict Litigations (MDL) in the U.S. District Court for the Southern District of West Virginia overseen by Chief Judge Joseph R. Goodwin. Over 49,000 cases are still pending in federal courts against the seven medical device companies that manufacture surgical meshes. The seven manufacturers are: Ethicon, American Medical Systems, C.R. Bard, Coloplast, Neomedic, Boston Scientific, and Cook Medical.
Boston Scientific Corp. faces the grand jury
Federal prosecutors from the grand jury in Charleston, W.Va., accused the medical device company Boston Scientific Corp. of using counterfeit raw material from China to produce thousands of TVM implants sold in America. Investigators of the Department of Justice allege that the Marlborough manufacturer knowingly used substandard resins in their products that never obtained clearance by the FDA, and fraudulently released defective devices to the U.S. market. Although the company keeps claiming that the adulterated materials did not compromise the overall product’s quality and safety, thousands of litigations have been filed by injured patients, 3,000 of which have been already settled with a $119 million payment.
How large is your settlement compensation going to be?
Suffering an injury caused by a medical device whose safety has never been properly tested before it’s released to the market is already a traumatizing event. However, the damage caused to the genital areas of women who were implanted with a transvaginal mesh goes beyond simple physical harm. Emotional damages cannot be underestimated. The complications of this defective device can, in fact, negatively affect a woman’s personal relationships and even the most simple daily activities such as walking, sitting and having sex with her partner. Complicated revision surgeries are often the only solution to manage the otherwise unbearable symptoms, which also require additional monetary expenses that exert a heavy burden on a family’s budget. Finding a competent attorney to file a litigation is often the only way to obtain that money to cover medical expenses and doctor’s bills through the legal system.
How much money you can seek in compensation depends on several factors, and an expert lawyer will know how to maximize your settlement. These factors include:
- How much the damage affected your mental and physical health
- The extent of the injury and its duration
- The mental anguish and psychological distress you suffered and are going to experience in the future
- Present, past and future medical expenses required to manage the complications
- Any loss of income or lost wages
- Loss of companionship or funeral expenses
To date, the verdict of several juries was in favor of the plaintiffs in many mesh cases. For this reason, U.S. District Judge Joseph Goodwin advised many device manufacturers to settle a number of out-of-court cases to cut losses and reduce court costs. Many parties so far opted to negotiate a settlement before trial, and several companies even settled large volume of disputes with global deals. Coloplast, for example, settled 400 cases by paying $16 million, while American Medical Systems paid $1 billion. The juries also provided several awards to individual women, including Martha Salazar’s $73.5 million verdict, and Deborah Barba’s $35 million award.