Transvaginal Mesh Lawsuits
More than 100,000 women and their families are claiming in transvaginal mesh lawsuits that their mesh did not function as intended and even caused serious injuries.
Some transvaginal mesh lawsuits have resulted in multimillion-dollar settlements.
In recent years the Food and Drug Administration (FDA) has warned that transvaginal mesh—used to treat women who are experiencing symptoms from pelvic muscle weakness caused by childbirth, surgery, or age—is associated with severe complications and that the devices are riskier than previously thought. Women claim in lawsuits that they were provided false and misleading information about the products’ safety and effectiveness.
In August 2017, Endo agreed to pay $775 million to resolve the remaining 22,000 lawsuits filed over its vaginal mesh implants.
How Transvaginal Mesh is Used
Transvaginal mesh is a medical device used to treat women suffering from pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Both of these conditions are common, with POP affecting an estimated 3 million U.S. women and SUI affecting roughly 15 million adult women in the U.S.
In a given year, around 75,000 transvaginal mesh procedures for POP are performed and about 200,000 cases of SUI are treated with mesh transvaginally.
“Transvaginal” refers to the insertion of surgical mesh through the vagina. Mesh can also be inserted through an abdominal incision, but transvaginal insertion is considered to be a quicker and less invasive procedure.
While surgical intervention is not necessary to treat POP or SUI, surgery may be recommended. The placement of transvaginal mesh is one surgical option. Surgery to repair POP and SUI can also be performed with tissue surgically removed from other parts of the body. Doctors who advocate surgical mesh assert that the devices provide better long-term outcomes than native tissue repair. In addition, some patients are not good candidates for native tissue repair of POP/SUI.
The Problem with Transvaginal Mesh
Transvaginal mesh is associated with severe health complications that were not evident until many years after mesh products were introduced to the market.
Most vaginal mesh is made from polypropylene, a material that can undergo substantial contraction after implantation and put pressure on pelvic nerves. Polypropylene may not be compatible with human tissue, which means that the body sees mesh as a foreign object and launches an inflammatory reaction. And because transvaginal insertion of mesh is performed “blind” (meaning that the surgeon cannot directly visualize placement of the mesh), there’s a chance that vital organs will be damaged by surgical instruments during surgery.
These issues can lead to vaginal mesh injuries that include:
- Urinary problems
- Protrusion of the mesh through the vagina
- Painful intercourse
- Recurrence of prolapse/incontinence
- Bowel, bladder, and blood vessel perforation
- Vaginal scarring/shrinkage
- Neuro-muscular problems
It’s estimated that hundreds of thousands of women have suffered transvaginal mesh complications—many of which might have been avoided through closer premarketing scrutiny of the devices.
Surgical mesh, originally designed to treat hernias, has been around since the 1950s. Mesh designed to treat POP and SUI was introduced in the 1990s, leading to a huge rise in transvaginal mesh procedures. The new devices, however, were approved despite a lack of clinical trial evidence demonstrating their safety and effectiveness.
A pelvic surgeon described mesh removal as “akin to taking a hammer and chisel and trying to remove the rebar from a sidewalk, while leaving the cement otherwise intact and not damaging the water mains and power lines below.”
In fact, it is official FDA policy that manufacturers seeking sales approval for transvaginal mesh are not required to submit clinical evidence of safety and effectiveness. Mesh manufacturers need only “demonstrate substantial equivalence of their product to a device that is legally marketed in the United States” in order to gain marketing permission.
This is possible through the FDA’s “510(k)” fast track approval program, which has come under considerable scrutiny in recent years. Commenting on a petition to ban surgical mesh for POP repair, one surgeon wrote that the 510(k) process “cannot ensure that mesh implants for transvaginal repair of POP are both safe and effective.” The Institute of Medicine has called the 510(k) process “fatally flawed.”
FDA, responding to a large number of adverse event (injury) reports submitted by manufacturers and patients, issued warnings about transvaginal mesh in 2008 and 2011.
Transvaginal mesh complications may be treated with additional surgery, but unfortunately, the growth of tissue into the mesh and the mesh’s proximity to vital structures makes complete removal of the device difficult or impossible.
During an FDA hearing on transvaginal mesh, a pelvic surgeon described mesh removal as “akin to taking a hammer and chisel and trying to remove the rebar from a sidewalk, while leaving the cement otherwise intact and not damaging the water mains and power lines below.”
In Their Own Words: Mesh Victims Speak Out
Responding to growing concerns about the safety of transvaginal mesh, FDA scheduled a 2011 meeting of its Obstetrics and Gynecology Devices Panel. The meeting contained a public hearing portion during which women harmed by vaginal mesh were given an opportunity to speak out about their medical traumas. Here’s some of what they had to say:
- “The pain from mesh left me unable to sit, exercise, or have any meaningful quality of life for months. I lived in excruciating pain 24 hours a day. Believing my situation was hopeless, at 42 and a mother of three, I seriously contemplated suicide to escape the grips of excruciating and unrelenting pain.” –Amy Gezon
- “A permanent medical device of synthetic mesh caused me serious harm. I had surgery on January 26, 2006 and suffered from serious complications of a hematoma. I had [the device] surgically removed one week later. I continue to have pain and suffering to this day from this medical device.” –Linda Dodson
- “I traded the inconvenience and embarrassment of stress urinary incontinence for a sling made of transvaginal mesh. Today, I wish I had never made that trade. It has completely changed every aspect of my life, personally and professionally. I still have SUI, but at the same time, I have great difficulty urinating and I have unrelenting pelvic floor pain that can’t be eliminated.” –Deborah Tedford
- “[My doctor] suggested that I have a sling inserted in my vagina to hold up my bladder. The procedure was done as an outpatient day surgery. I was sent home after the surgery with an inserted catheter and was told by the doctor that I should recover in two to three weeks. Well, I didn’t recover in two to three weeks. It took me five months just to get out of bed.” –Diane Maassen
- “Shortly after having mesh implanted, I had emergency surgery to remove some of the posterior arms of the mesh. Little did I know that I would leave the hospital with open, draining [cysts] for nine-plus weeks trying to heal. There were more doctors, more tests, and a decision was made. It was too dangerous to remove the rest of the arms, so just leave it alone and go to a pain doctor.” –Beverly Pennington
Women who filed transvaginal mesh lawsuits generally allege that mesh manufacturers:
- Failed in their legal duty to ensure the safety and effectiveness of mesh products
- Did not conduct adequate and well controlled studies of their products prior to marketing
- Provided inadequate warnings of potential mesh complications and patient harm
- Intentionally misled the public into believing that mesh is safe and effective
- Negligently designed and manufactured mesh products
Cases Consolidated in Federal, State Courts
Seven manufacturers, including Boston Scientific, Johnson & Johnson, and C.R. Bard, face an estimated 100,000 lawsuits over transvaginal mesh in the United States. Most of these cases are consolidated as part of a multidistrict litigation (MDL) in West Virginia federal court. Thousands of mesh lawsuits are also centralized in New Jersey state court.
Mesh Lawsuit Settlements
A positive development for transvaginal mesh victims is that some lawsuits have settled in favor of plaintiffs, with awards that include:
- $100 million verdict for a woman implanted with Boston Scientific’s Pinnacle and Advantage fit mesh products
- $73.5 million verdict for a woman implanted with Boston Scientific’s Obtryx sling
- $14.3 million awarded to three plaintiffs who suffered injuries from Boston Scientific’s Obtryx pelvic mesh devices
- $13.5 million awarded to a victim of Ethicon’s (J&J) Transvaginal Tape
- $12.5 million awarded to a woman injured by Ethicon’s Prolift pelvic mesh implant
- $3.6 million in damages for a victim of C.R. Bard’s Avaulta Plus vaginal implant
In addition to these individual settlements, American Medical Systems has set aside $1.9 billion to settle up to 49,000 mesh lawsuits, Endo paid $830 million to settle about 20,000 claims, and Coloplast settled 400 cases for $16 million.
How a Lawsuit Can Help
If you experienced medical device complications, you may qualify for a lawsuit.
Taking the next step in the legal process is easy: contact us for a free, no-obligation case review.