Vaginal Mesh Products Failing at Alarming Rates
Vaginal mesh surgical products are failing at an alarming rate and the government is being urged to recall all these products immediately. In July 2011, the U.S. Food and Drug administration issued a public warning, announcing it had received 2,800 complaints about serious complications developing after the products were used to surgically repair urinary tract leaks in women.
Product manufacturers may not have tested these devices thoroughly enough or long enough to determine if they were safe. Most of these products were allowed to bypass strict government testing requirements. Because of this, thousands of women who have undergone this surgery are at risk. The FDA has reported that complications arising from use of mesh products are not rare, and that other forms of treatment may be preferable.
If you or a loved one underwent surgery to implant a vaginal mesh product, including a sling, and later developed serious complications, you have the right to hold manufacturers responsible. Although a lawsuit won’t ease suffering or permanent disability, it can help pay medical expenses, improve the chances for quality of life or compensate for income or other losses. An experienced vaginal mesh attorney with Janet, Jenner & Suggs can review your situation and advise you. All consultations are free of charge.
Consumer Alert
An estimated 75,000 women in the U.S. have undergone surgery to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Vaginal mesh products used in these surgeries are under scrutiny for a possible government recall because of an alarming failure rate.
According to the FDA, one of the most common and consistently reported complications is that the mesh erodes into surrounding organs. Other complications include:
- Bleeding
- Infection
- Perforation into the bladder
- Painful sexual intercourse (dyspareunia)
- Pelvic pain
- Infection
- Additional surgeries to correct the complications
Symptoms of Vaginal Mesh Failure
A woman who had vaginal mesh implanted during surgery and who experiences the following symptoms should see her doctor right away:
- Fever
- Bleeding
- Pelvic pain
- Vaginal discharge
- Vaginal pain
- Painful sexual intercourse
- Recurrence of prolapse or incontinence
- New onset of urinary incontinence
Pelvic Prolapse and Stress Incontinence
SUI occurs when there is an involuntary loss of urine during physical activity such as, laughing, coughing, sneezing or exercising. Common causes of this condition include: childbirth, getting older, persistent cough or obesity. Stress urinary incontinence affects up to 40 percent of American women and is expected to increase as the U.S. population ages.
POP occurs when the ligaments and muscles that support the pelvic organs become so stretched and weakened that they cannot hold the pelvic organs in place and descend into the vagina. The most common organ to prolapse, or descend, is the bladder, but sometimes the rectum or uterus will prolapse into the vagina.
In 2010, approximately 300,000 women in the U.S. had surgery to repair POP, including 75,000 of whom had surgical mesh transvaginally implanted, according to the FDA.
History of Problems
On July 13, the FDA issued an urgent public notice about the medical devices after receiving thousands of reports of painful complications. The agency reported it had received over 2,800 reports of complications between January 2008 and December 2010. It said serious complications associated with surgical mesh for transvaginal repair of POP are not rare. It advised health care providers that in most cases, POP could be treated successfully without mesh surgery.
The national consumer group Public Citizen has called for a ban on marketing all surgical mesh products made for transvaginal mesh surgery and for any future versions of the mesh to be classified as Class III medical devices. This would provide stricter approval requirements.
Concerns Cross all Product Lines
Nine companies manufacture transvaginal mesh products, including Boston Scientific, Johnson & Johnson, C.R. Bard, Tyco Covidian and AMS.
Concerns are not limited to any single vaginal mesh product. Products currently on the market include the following:
- Advantage™ Sling System
- Lynx™ Suprapubic Mid-Urethral Sling System
- Obtryx® Curved Single
- Obtryx® Mesh Sling
- Prefyx Mid U™ Mesh Sling System
- Prefyx PPS™ System
Legal Help for Victims of Defective Vaginal Mesh Products
If you or a loved one were treated with a vaginal mesh product, including a sling, and suffered injuries or losses as the result, you may have valuable legal rights. Please fill out our online form, or call us toll-free at 1-877-My-Advocates (1-877-692-3862) to discuss your case with one of our vaginal mesh injury lawyers today.
For Additional Resources on Transvaginal/Sling/Mesh Products
