For patients who undergo pelvic prolapse surgery with a vaginal mesh device, numerous adverse health complications can result. Transvaginal mesh placement for pelvic organ prolapse (POP) and stress urinary incontinence (SUI) has recently been associated with erosion, infections, pain, dyspareunia, organ perforation, and recurrence of the urinary problems the mesh was implanted to treat in the first place. Research has found that upwards of 10% of women who undergo pelvic prolapse surgery with mesh products will suffer from one or more of these problems in less than a year after the procedure is performed.
Free Confidential Case Evaluation: If you or a loved one has been injured or suspect that you may have complications directly linked to the placement of a vaginal mesh product during pelvic prolapse surgery, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
Repair of Pelvic Organ Prolapse (POP)
For women suffering from POP who do not respond to nonsurgical treatment and lifestyle changes, pelvic prolapse surgery may be an option. The specific procedure depends upon the organs involved, how severe the symptoms are, and what other medical conditions the patient suffers from. The goals of pelvic prolapse surgery are to relieve the symptoms and restore the function of the damaged organs. Signs and symptoms of pelvic organ prolapse may include:
- Pelvic pressure
- A feeling as if something is falling out of the vagina
- A pulling or stretching in the groin area
- Low backache
- Pain during sex
- Spotting or bleeding
- Urinary problems
- Problems with bowel movements
Conventional POP treatment included surgery, in which a patient’s own tissues are used to provide support for the prolapsed organ. Starting in the early 2000s, surgeons began using vaginal mesh devices in pelvic prolapse surgery. While manufacturers of the products claim that mesh is superior for treating POP, the Food and Drug Administration says there is no evidence to support those claims. Moreover, after receiving thousands of adverse event reports (AERS) linked to transvaginal mesh for pelvic prolapse surgery, the FDA has issued several warnings about the safety of the devices.
Transvaginal Mesh FDA Warning
In July 2011, the FDA issued a warning stating that using transvaginal mesh for pelvic prolapse surgery may be riskier than conventional POP surgery. According to the administration, the number of complications linked to mesh has been increasing steadily over the past few years. Almost 3,000 AERS were filed with the FDA between 2008 and 2010 – five times as many as were submitted in the previous three years.
In 2010, there were more than 100,000 pelvic prolapse surgeries done with mesh products, 75,000 of which were transvaginal procedures. The FDA said that in most cases, pelvic prolapse can be addressed with more traditional treatments that do not include mesh. The administration also stated that mesh devices are designed to be permanent, and removing them can put recipients at risk for additional complications and future revision surgeries.
Pelvic Prolapse Surgery Complications
Risks of pelvic prolapse surgery using vaginal mesh may include:
- Urinary incontinence
- Urinary retention
- Painful intercourse
- Bladder injury
- Formation of an abnormal connection or opening between two organs (fistula)
Do I Have a Pelvic Prolapse Surgery Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in transvaginal mesh lawsuits. We are handling individual litigation nationwide and currently accepting new transvaginal mesh pelvic prolapse surgery lawsuits in all 50 states.
Free Pelvic Prolapse Surgery Lawsuit Evaluation: Again, If you or a loved one has been injured or suspect that you may have complications directly linked to pelvic prolapse surgery and/or the placement of a vaginal mesh product, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.