Update to post below: Our vaginal mesh lawsuits have settled and we are no longer able to take these cases. If you have any questions regarding the settlement, please call 1-888-377-8900 (toll free) to talk to an attorney.
Our law firm is representing women throughout the United States who were injured by mesh products used in prolapse surgery and to treat stress urinary incontinence. Of counsel David Szerlag has been appointed a leadership position in an action to consolidate the pretrial proceedings of certain mesh lawsuits (American Medical Systems mesh lawsuits filed by victims from a number of states).
Our clients trusted the manufacturer of the mesh product to provide a safe product, but they experienced one or more of the following:
- Erosion of the mesh into the vagina, bladder and/or rectum
- Protrusion of the mesh
- Mesh shrinkage (causing vaginal tightening and severe pain)
- Infection
- Pelvic pain
- Intense pain preventing intimate relations
- Bleeding
- Recurrence of the prolapse.
Pelvic Organ Prolapse Surgery
Pelvic organ prolapse happens when the tissues that hold the pelvic organs (generally the bladder of vagina, but also the rectum and uterus) in place become weak or stretched. When it happens, the organs bulge (prolapse) into the vagina and sometimes prolapse past the vaginal opening. More than one pelvic organ can prolapse at the same time.
Stress Urinary Incontinence
Stress urinary incontinence (SUI) is a leakage of urine during moments of physical activity, such as coughing, sneezing, laughing, or exercise.
FDA Warns of Mesh Complications
In July of 2011, the FDA issued a warning regarding certain mesh products manufactured by the following:
- American Medical Systems (AMS)
- Ethicon (a Johnson & Johnson (J&J) company)
- Boston Scientific
- Bard Avaulta.
[Note: Since the warning was issued, hundreds of lawsuits have been filed, and Ethicon has told the FDA that it will no longer sell the mesh products addressed in the warning.]
In the warning, the FDA stated that “serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapse (POP) are not rare.” This is a change from what the FDA previously reported on Oct. 20, 2008. At that time, the FDA had received over 1000 reports of adverse events. Since 2008, there have been thousands of additional reports of complications that caused serious harm to women.
The most frequent complications reported to the FDA when the mesh was used for pelvic prolapse surgery include mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.
The FDA’s review of the medical literature on the issue of mesh problems found that using mesh for transvaginal pelvic organ prolapse repair is riskier than non-mesh surgery, and may not provide any added benefit that would justify its use. The literature review also found:
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.
Attorneys Fred Pritzker and David Szerlag are available for a free consultation regarding a mesh lawsuit.