Urinary incontinence, another name for loss of bladder control, is a medical condition that can range in severity from minor and occasional urine leakage when coughing or sneezing to having an urge to urinate that is too strong to control. In cases in which loss of bladder control is serious, some women have undergone transvaginal mesh surgery.
Stress Urinary Incontinence (SUI) involves the loss of urine when pressure—or stress—is exerted on the bladder upon coughing, sneezing, laughing, exercising, or heavy lifting. SUI takes place when the sphincter muscle of the bladder is weakened, which can result from the physical changes caused by pregnancy, childbirth, and menopause.
Transvaginal Mesh Complications
Transvaginal mesh surgery is often used as treatment method for SUI. Transvaginal mesh devices are approved for the treatment of SUI as well as for pelvic organ proplapse (POP) in which weakened pelvic muscles cause organs to slide out of place. In the treatment of SUI, the vaginal mesh is implanted to strengthen pelvic walls.
The devices were approved through a U.S. Food and Drug Administration fast-track process known as the 510(k). Under the 510(k), a formal review for safety and efficacy is neither required nor performed. Because the 510(k) route has been used to gain clearance for transvaginal mesh and other controversial devices, the process has drawn increasing criticism.
Thousands of women were recipients of transvaginal mesh devices and, now, the devices have come under intense scrutiny as many women who were implanted with these devices are reporting complications allegedly related to their defects. According to a prior FDA Safety Communication, the most common reported adverse events related to transvaginal mesh includes:
- Mesh erosion through the vagina (exposure, extrusion, protrusion)
- Pain during sexual intercourse (dyapareunia)
- Organ perforation
- Repeat and increased urinary problems.
Perhaps the most debilitating aspect associated with the alleged risk of erosion—when the transvaginal mesh travels through the body’s tissues—is that the mesh can become embedded in inappropriate areas. This defect can lead to multiple surgeries to remove the device; however, the erosion is often so significant and widespread that the mesh cannot ever be completely removed.
Transvaginal Mesh Lawsuits
Transvaginal mesh lawsuits brought following surgeries to treat SUI continue to mount. Johnson & Johnson faces some 1,800 lawsuits in New Jersey state courts, alone; Endo facing nearly 3,000 lawsuits. In fact, tens of thousands of lawsuits have been been filed against a number of transvaginal mesh device makers, with lawsuits filed in state and federal courts nationwide and based on allegations that the devices led to injuries after women were implanted with the mesh device to treat their SUI symptoms.
Last June, device maker Ethicon—a unit of Johnson & n—announced it would no longer sell four types of transvaginal mesh devices, including the Prolift + M™, TVT Secur, Prolift, and Prosima. Recently, the first transvaginal mesh lawsuit to go to trial led to an $11.1 million verdict in favor of the plaintiff. That case was the first of 4,000 Gynecare Prolift cases expected to go to trial. Johnson & Johnson was ordered to pay $3.35 million in compensatory damages and $7.76 million in punitive damages.
The FDA warned that complications associated with transvaginal mesh implants are “not rare,” and also stated that no clear evidence exists that transvaginal mesh is better than non-mesh methods for treating POP and SUI and has asked 33 manufacturers to conduct post-market studies evaluating the dangers of transvaginal mesh.