Transvaginal Mesh Complications

Severe vaginal mesh complications reported by patients are not only physically disabling, they’re emotionally taxing and have ruined intimacy between partners due to their pervasive nature. What should have been a routine procedure to repair symptoms of stress urinary incontinence or pelvic organ prolapse (POP) has morphed into a living nightmare for thousands of women.

One South Dakota woman was awarded a multi-million dollar verdict after jurors listened to testimony in which she described 18 grueling revision surgeries to address surgical mesh problems that have left her unable to sit for long periods of time or enjoy the companionship of her husband. The New Jersey Supreme Court jury found that the defendant, Ethicon, had failed to warn the woman’s surgeon about the risks of transvaginal mesh complications, and that there was blatant misrepresentation of the procedure in patient brochures.

Her story mirrors that of myriad women throughout the nation who turned to transvaginal mesh products to help them repair weakened or compromised pelvic floor muscles. In 2011, the FDA warned that transvaginally placed mesh in POP repair may expose patients to greater risks, and such procedures show no better clinical outcomes compared to non-mesh repairs.

Transvaginal mesh timeline

Federal regulators believe the overall increase in adverse event reports involving pelvic mesh are cause for concern. Since their launch nearly two decades ago, vaginal mesh devices have been tied to life-shattering injuries and complications, spurring a wave of products liability litigation against manufacturers.

• 1990’s: Physicians began using surgical mesh for transvaginal POP repair and treatment of SUI
• 2002: FDA clears the first pelvic mesh product specifically designed for pelvic organ prolapse repair
• 2003-2005: Various mesh manufacturers, including J&J, Boston Scientific, American Medical Systems, C.R. Bard and Cook Medical, develop transvaginal mesh kits
• 2005-2010: FDA receives nearly 4,000 reports of serious injury and complications associated with vaginal mesh failure
• 2011: FDA deems that transvaginal mesh complications are “not rare”
• 2012: J&J suspends sales of Gynecare Prolift mesh implants in the wake of litigation, calling this measure a “global discontinuation”
• 2012: FDA orders post-market surveillance studies by manufacturers of surgical mesh products to address safety concerns related to mini-sling devices for SUI and surgical mesh used for transvaginal repair of POP
• 2013: Mesh manufacturers like Bard begin settling federal pelvic mesh lawsuits that allege severe injuries, thousands of cases are still pending trial

1 in 10 patients suffer surgical mesh problems

Research has found that 10 percent of women implanted with pelvic mesh will experience complications, the most common being mesh erosion. Also known as extrusion, this side effect is one of the most destructive, as the material infiltrates surrounding tissues, causing severe infection, scarring, painful intercourse and other harm. Even with several revision surgeries, there is no guarantee that the mesh can be fully explanted.

Women suffering from vaginal mesh complications often report:

• Vaginal mesh erosion
• Excruciating pain
• Mesh contraction
• Chronic infection
• Painful sexual intercourse
• Bowel, bladder, and blood vessel perforation
• Vaginal scarring
• Organ perforation
• Need for multiple revision surgeries
• Emotional trauma
• Recurrence of urinary incontinence
• Relapse of POP

Surgical mesh problems, depending on the severity and extent, may be treated with corrective surgery to remove the mesh device, blood transfusions, drainage of abscesses and/or hematomas, prescription pain medications and anti-inflammatory drugs, and IV therapy.

The FDA has analyzed thousands of adverse events and determined that transvaginal mesh failure and complications are not limited to one model or manufacturer; instead these debilitating side effects have been witnessed across the board in women implanted with bladder slings and mesh patches made from varying materials – both synthetic and bio-compatible.

Emotional damages cited by women

Beyond the horrific physical injuries that failed vaginal mesh can cause, the emotional hardships endured by women can be equally catastrophic. One patient, Amber Smith, told the New York Times her tragic story of persistent pelvic pain, irregular bleeding and constant drainage, following six surgical procedures. “To call this an ordeal is an understatement,” she recounted on her blog, adding “It’s been life-altering.” Unable to work while healing from surgery, some women say they now suffer from anxiety and severe depression.

Many who have decided to file vaginal mesh lawsuits claim that their relationships have been strained for lack of intimacy with their partners. Spouses of these women often demand damages for loss of consortium — an award that has been granted in several vaginal mesh trials to date.

Medical studies on transvaginal mesh complications

After being ordered to conduct further research on the safety and efficacy of their mesh products this past year, more than 30 manufacturers began clinical trials. The results have not been encouraging, as one study discovered that 15.6% of patients developed surgical mesh erosion. The American College of Obstetricians and Gynecologists reports that this failure rate was so significant that enrollment into the study was halted, over concerns of patient safety.

The study, which included 63 women, was designed to follow treatment outcomes over the course of three years, but was stopped due to unreasonably high complication rates, again suggesting there are no demonstrated medical benefits associated with the use of vaginal mesh. Such research only bolsters allegations made by at least 30,000 women who are taking their grievances to court.

For most victims, painful and costly revision surgery is the only recourse for serious complications from pelvic mesh. But even with repeat attempts, corrective surgery isn’t always able to address internal damage caused by mesh extrusion and erosion.

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