Transvaginal Mesh Warnings and Litigation
The Food and Drug Administration (FDA) has received more than 3,000 reports of complications associated with transvaginal mesh – surgical devices used to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
A net-like implant device, transvaginal mesh is typically made of porous absorbable or non-absorbable synthetic material or absorbable biologic material. The term “transvaginal” means through the vagina – and refers to the surgery used to implant the mesh.
Transvaginal mesh products are inserted into the abdomen or pelvis to alleviate pressure on tissue which has been damaged or weakened, often through hysterectomy, childbirth or menopause. Increasing numbers of women have reported serious complications from the use of these mesh products, which include bladder slings, patches and tape.
In 2008, the FDA issued a safety alert addressing complications related to transvaginal mesh devices.
Three years later, the agency warned that there had been a dramatic increase in reports of problems associated with the use of vaginal mesh.
At this time, the FDA warning about the use of transvaginal surgical meshes to treat pelvic organ prolapse and urinary leakage and noted that thousands of women have reported serious complications. According to the FDA it is “not clear that transvaginal POP repair with mesh is any more effective than traditional repair and may expose patients to greater risk.”
The surgical procedure involving mesh has become more prevalent in recent years. In 2010, more than 75,000 women underwent vaginal surgery with mesh to repair POP.
POP affects many women as they age, with the FDA estimating that up to 50 percent of all women may experience it during their lifetimes. POP occurs when the tissue holding the uterus, bladder, bowel and rectum is weakened, allowing the organs to prolapse – or slip out of place. Pelvic Support Problems
SUI results in leakage of urine, especially if the patient coughs, laughs or exercises.
Typically, surgical mesh is implanted to reinforce the weakened vaginal wall – either to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence. By reinforcing the vaginal wall and urethra, transvaginal mesh is designed to mitigate the negative impact of SUI and POP.
Unfortunately, over time, erosion or contraction of the mesh can result in serious injuries and complications.
In fact, thousands of women have suffered the effects of improperly placed mesh, and thousands of cases have been consolidated into multidistrict litigation (MDL) in the U.S. District Court of West Virginia. These lawsuits allege that various models share similar design flaws and risks. The cases were centralized into MDL because they all contain similar sets of facts and injuries.
A variety of mesh devices have been marketed and sold by companies including: Gynecare, American Medical Systems (“AMS”), Boston Scientific, C.R. Bard, Inc., Ethicon and Johnson and Johnson.
However, the complications associated with the use of surgical mesh have not been linked to a single brand.
Transvaginal Mesh Side Effects
The most common complication reported to the FDA for surgical mesh devices involves mesh erosion – which can damage the tissue of the vaginal wall – causing pain, infection, bleeding, organ perforation and urinary problems. Another potential consequence is mesh shrinkage, which may cause a painful shortening and tightening of the vagina
Equally painful is transvaginal mesh organ perforation, which can occur when the sharp edges of mesh cut into organs.
Ironically, many women have reported a reoccurrence of vaginal prolapse or stress urinary incontinence when using these devices.
How CaseyGerry Can Help
Because the manufacturers of transvaginal meshes have failed to warn about their products’ risk, women suffering mesh complications may be able to file claims seeking compensation for medical bills, lost wages, pain and suffering and other damages.
The pharmaceutical attorneys at CaseyGerry have decades of experience in the field of medical device litigation. We can offer legal guidance as well as help and support to those who have suffered sustained injuries due to transvaginal mesh products.
If you believe that you or a loved one may have been injured as the result of a transvaginal mesh product, please contact us today for a free consultation and case review.