Women diagnosed with pelvic organ prolapse or stress urinary incontinence may have transvaginal mesh devices implanted during surgery to repair the damage. This plastic, net-like material made of polypropylene, also known as urogynecologic surgical mesh, has caused health issues in thousands of patients. These health problems typically occur because of faulty product design or improper surgical implantation technique. While the mesh can be implanted via abdominal surgery, vaginal implantation is the more common route for women suffering from pelvic floor disorders. Vaginal implantation is far less invasive than traditional surgery, with less time spent in the operating room. Contact a Boston Defective Medical Device Lawyer Today.
Pelvic Floor Disorders
Pelvic floor disorders generally occur after childbirth or hysterectomy, or in postmenopausal women. Prolapse is usually due to weakening of the pelvic muscles, which allows the uterus, bladder or rectum to enter the vagina. Surgeons use prepackaged transvaginal mesh kits to repair the prolapse. The problems experienced by women undergoing these procedures are directly linked to certain manufacturers. Currently, C.R. Bard, Ethicon, and Boston Scientific are facing the majority of injury lawsuits for mesh devices.
Transvaginal Mesh Complications
Transvaginal mesh devices may start breaking through the vagina walls or other parts of the body not long after implantation. Bladder, bowel and blood perforation are not uncommon. Some women suffer these complications just weeks after their surgeries. Side effects, some of which are life-threatening, include:
- Severe pain
- Painful intercourse
- Vaginal tissue scarring
Affected women often have to endure additional surgeries to repair the damage caused by the transvaginal mesh devices.
The FDA and Transvaginal Mesh Devices
Hundreds of thousands of women may have been affected by faulty transvaginal mesh products. In early 2012, the FDA issued “522 orders” – formally known as post-market surveillance orders – to all manufacturers of these products. These orders resulted in some manufacturers withdrawing their mesh kits from the market. Other manufacturers issued voluntary recalls. Some companies changed the product labeling, indicating that their mesh kits are only used for abdominal implantation.
On January 4, 2016, the FDA reclassified transvaginal mesh devices as high risk when used in transvaginal operations for organ prolapse repair. The classification remains at moderate risk for such procedures performed abdominally, or for stress urinary incontinence.
The American Urogynecologic Society
While the American Urogynecologic Society, representing those physicians who treat women with incontinence and pelvic floor disorders does not seek a ban on transvaginal mesh, a 2011 statement included this position: “Pelvic organ prolapse vaginal mesh repair should be reserved for high‐risk individuals in whom the benefit of mesh placement may justify the risk, such as individuals with recurrent prolapse (particularly of the anterior compartment) or with medical co-morbidities that preclude more invasive and lengthier open and endoscopic procedures” and that such procedures be performed by appropriately trained surgeons.”
Altman & Altman, LLP – Boston’s Defective Mesh Law Firm
Women experiencing complications from transvaginal mesh device surgeries may be eligible to seek compensation for their medical bills, lost wages, and pain and suffering. If you or a loved one has suffered complications stemming from a transvaginal mesh device, Altman & Altman, LLP can help. Our skilled defective product attorneys will evaluate your case details to ensure that you understand your rights and options before moving forward as part of a transvaginal mesh device lawsuit. Contact us today for a free consultation about your case.