After much deliberation, a New Jersey court has decided to uphold a mesh settlement of more than $11 million to a Linda Gross, a South Dakota nurse surviving transvaginal device complications.
Though the case represents a successful outcome for those advocating against failed mesh, thousands of women awaiting settlements are still dealing with serious side effects.
What is transvaginal mesh?
Transvaginal mesh is a plastic medical netting used to treat feminine health issues. Intended as a permanent fix for pelvic organ prolapse (POP) and stress urinary incontinence (SUI), transvaginal mesh may fail and cause a number of biological and emotional complications.
Some of the side effects associated with vaginal mesh may be considered moderate, while others are life-threateningly severe. The plastic netting can fuse to organs and tissue, making it extremely difficult to remove. Many women dealing with mesh failures may require numerous revision surgeries in an attempt to correct chronic pain and other problems impacting overall quality of life.
Additional complications of vaginal mesh include, but are not limited to:
- Abdominal pain
- Irregular bleeding
- Dyspareunia (pain during sex)
- Mesh erosion
- Organ perforation
- Urinary complications
- Recurrent POP/SUI
- Neuro-muscular problems
- Vaginal scarring/shrinkage
- Emotional harm
The Food and Drug Administration (FDA) initially approved vaginal mesh in 1996 under the agency’s expedited 510(k) approval process. Mesh products were originally marketed as a treatment for abdominal hernias. The FDA released multiple safety alerts related to vaginal mesh since its approval, listing the product as a class III device and confirming that complications are “NOT rare.”
Million-Dollar Mesh Settlement
Despite the risks, transvaginal mesh still exists on the market. Women suffering from mesh complications may file a lawsuit to assist with medical bills and threats to earning income, while holding the manufacturer accountable for a lack of transparency.
The Linda Gross transvaginal mesh case was the first to be tried in a New Jersey courtroom. Though the legal process dragged on for years, the lawsuit ultimately resulted in a $11.1 million settlement for the injured plaintiff.
Gross, who had the Prolift mesh implant, filed a lawsuit in 2008. Prolift is manufactured by Ethicon, a subsidiary of the pharmaceutical juggernaut Johnson & Johnson.
Though the verdict wasn’t released until 2013, Gross suffered from severe pain that led her to seek medical assistance. She underwent 18 revision surgeries.
Despite a series of painful injuries and mounting medical bills, Johnson & Johnson presented an appeal in March 2016. According to Bloomberg, the jury found the manufacturer guilty of failing to inform the patient of the risks associated with vaginal mesh.
The court of New Jersey upheld the million-dollar mesh settlement, setting a legal example in favor of feminine health and safety. While some plaintiffs have received substantial settlements, others are still awaiting trial.
Thousands of vaginal mesh lawsuits exist today. In an attempt to hasten the process, the legal system has consolidated the complaints to be tried in West Virginia and New Jersey courts. Known as a multi-district litigation, the collaborative hearings will expedite large, complex cases like personal injury suits.
Though Johnson & Johnson is one of the most prominent mesh manufacturers, other mesh producers include:
- American Medical Systems
- Boston Scientific
- C.R. Bard
- Sofradim (acquired by Covidien; formerly named Floréanne)
A major manufacturer of vaginal mesh, Johnson & Johnson has been hit hard in the legal sphere. Though the company attempted to reverse the mesh settlement, it will be held responsible for millions in damages.
Individuals who testified in court illustrated that Johnson & Johnson would be able to afford the awards. According to Bloomberg, forensic economics expert Frank Tinari testified that Johnson & Johnson boasted a new worth of $121.3 billion and spent $57 million on daily marketing through Dec. 31.
The breadth of the MDL is staggering. Lawsuits from more than 80,000 individual plaintiffs have been consolidated into one of the largest collaborative national litigations to date, aiming to have justice as soon as possible.