Seeger Weiss is investigating reports of severe complications associated with transvaginal surgical mesh and bladder slings. The FDA has issued a warning of the complications arising from mesh devices, which are surgically installed to help treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). These mesh devices act like a hammock and are surgically placed transvaginally (along and behind the vagina) to support the uterus, the bladder, and other pelvic organs. Between 2005 and 2008 alone, the FDA had received more than 1,000 reports of injured women.
The most common complications reported include:
- urinary problems
- vaginal scarring
- mesh erosion through the vaginal tissue
- recurrence of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI)
- perforations of the bowel, bladder or blood vessels
These injuries can occur following surgical placement of the transvaginal mesh, others (including perforation of the bowel, bladder, and blood vessels) can occur during the procedure itself. The FDA urges doctors to warn patients of the potential for scarring, vaginal wall narrowing (in POP repair), and pain during sexual intercourse, that can result from this surgical procedure.
The complications resulting from surgical mesh often require invasive and costly medical treatments including surgical repair (sometimes involving the removal of the mesh device), IV therapy, drainage of hematomas or abscesses and blood transfusions.
In a recent study released by the Department of Gynecology Obstetrics and Reproductive Medicine in France, serious side effects were found in 81% of the 104 women tested. 38% of the cases showed evidence of the most serious side effects.
While any woman who has had transvaginal mesh surgically installed is at risk, some women may be more vulnerable to the most severe side effects.
While the specific risk factors are not completely understood, the FDA reports that the following factors may affect a woman’s risk:
- overall health
- type of mesh material used in device
- size and shape of transvaginal mesh device
- surgical technique used to implant the device
- other surgeries, such as a hysterectomy
- estrogen status
Despite the thousands of injuries caused by transvaginal mesh, this medical device remains on the market, posing serious risks to the thousands of women who undergo POP and SUI surgery each year.
Transvaginal surgical mesh is manufactured by numerous large pharmaceutical companies, including:
- Johnson & Johnson
- American Medical Systems
- Boston Scientific
- Ethicon division of Johnson & Johnson
On October 12, 2010, the Honorable Carol E. Higbee of the Superior Court of New Jersey Law Division, Atlantic County was assigned to oversee the centralized management without mass tort designation for all filed complaints and all future complaints in the transvaginal mesh cases In re: Pelvic Mesh/Gynecare Litigation and In re: Bard Litigation.
If you or someone you know has suffered complications from transvaginal surgical mesh or bladder slings, contact us today. Reporting your experience can help protect other women from being harmed by these dangerous devices, and you may be entitled to compensation for your injury. An experienced attorney with Seeger Weiss LLP will assist you in evaluating your claim. Attorney consultations incur no obligation on your part and all initial consultations are free of charge. Seeger Weiss LLP has office locations in New York, New Jersey, and Pennsylvania.
More detailed information about transvaginal mesh litigation can be found at Drug Dangers.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.