Why Slings Failed

Why Vaginal Slings Failed

It is estimated that more than 50 percent of all women who have children will suffer some type of prolapse throughout their lives and nearly 10 percent of these women will require surgery for this health condition. Pelvic Organ Prolapse happens when muscles and ligaments supporting the pelvic organs weaken or slip out of place. This may be a direct result of pregnancy where the muscles and ligaments are weakened by the added weight experienced during pregnancy. POP can also lead to bladder and bowel slippage which places abnormal pressure on the vaginal area causing pain and discomfort.

Vaginal mesh implants were seen as a revolution in dealing with Pelvic Organ Prolapse (POP), helping women avoid more invasive treatments. So these companies can along and designed and developed implanted synthetic surgical mesh devices to correct and restore normal vaginal structure secondary to pelvic organ prolapse.

The idea of vaginal mesh implants was conceived in France in the late 90s and requires the placing of a sling via the groin to support the weakened muscles and ligaments. The first commercially produced vaginal mesh used was a silicone-coated sub-urethral product called Uratape. It was later withdrawn from the market because of the high incidence of vaginal mesh extrusion and was later replaced with today’s vaginal mesh slings.

Did the manufacturers learn from the Uratape debacle? They didn’t. Now there is a target on the back of most of these manufacturers, including:

• Bard Avaulta Support System
• AMS Elevate Prolapse Repair System
• AMS Apogee Vault Suspension System
• AMS Perigee System
• AMS Monarc Sling System
• AMS Sparc Sling System
• Boston Scientific Pinnacle Pelvic Floor Repair Kit
• Boston Scientific Uphold Vaginal Support System
• Ethicon Gynecare Gynemesh
• Ethicon Gynecare Prolene Soft Mesh
• Ethicon Gynecare Prolift Pelvic Floor Repair System
• Ethicon Gynecare TVT Transvaginal Sling
• UGYTEX Dual Knit Mesh
• Coviden IVS Tunneler Sling
• Monarch Suburethral Sling

Ethicon is Johnson & Johnson, who recently took a big verdict in one of these cases.

Mesh Slings and the Federal Drug Administration (FDA)

The FDA in 2008 released a public health alert regarding the potential complications of vaginal mesh for women suffering from pelvic organ prolapse. This was in response to the growing number of complaints regarding the use of vaginal mesh treatments in the management of pelvic organ prolapse.

Nine separate manufacturers of trans-vaginal mesh treatments were named in the report including C.R. Bard, makers of Avaulta Plus, Avaulta Solo, and Avaulta Biosynthetic. Some of the common medical complications reported included recurrence of POP, infection, pain during sex, urinary problems, and bowel and bladder perforation.

Mesh Sling Problems and Complications

A report coming from the 2004 World Health regarding vaginal mesh procedures also showed an unacceptable rate of medical complications regarding such procedures. This resulted in numerous recommendations suggesting that vaginal mesh treatments be placed on hold until they have been certified as safe by the medical community.

Manufacturers of vaginal mesh products have also been blamed for not coming forward about the real risks and complications regarding this medical procedure. Adding to the criticisms is the fact that there has been no recall and the makers of these vaginal mesh products continue to promote the treatment as safe and effective for managing Pelvic Organ Prolapse. Largely, they just pretended there was no real problem.

Complications with vaginal sling surgery include:

• Pain during intercourse
• Pelvic pain
• Erosion of the mesh into the vagina
• Pelvic Organ Prolapse relapse
• Injury to nearby organs
• Urinary problems
• Bladder and bladder perforation

All of which can lead to long-term internal injuries and severe pain.

Vaginal Sling Class Action Lawsuits

Lawsuits being filed against vaginal mesh manufacturers stem from allegations that the manufacturers were not totally honest regarding the possible complications and side effects of the medical procedure and the use of their vaginal slings. Studies show that a growing number of women have reported medical complications and injuries after undergoing vaginal mesh implant surgery. This has been largely attributed to defects in the design of the Avaulta vaginal mesh and similar products. These products allow tissue infiltration which increases the risk when removing the vaginal mesh. Removal of the Avaulta vaginal sling can cause long-term and, sometimes, irreparable damage.

Women who have experienced mesh problems, such as mesh erosion and pain, may be able to participate in a class action lawsuit and receive financial compensation for damages. Hundreds of vaginal mesh lawsuits have already been filed, and women who have developed complications after being implanted with a mesh implant to treat pelvic organ prolapse may be able to file a claim for medical bills and other damages.

Getting a Lawyer

Thousands of women remain implanted with vaginal mesh implants and suffer from or are at risk of suffering from vaginal mesh extrusion. Transvaginal mesh lawsuits are pending around the country. You may be able to receive money for your pain and suffering, lost wages, medical bills, and other damages related to your Avaulta mesh complications.

Lawsuits are never a sure thing but we believe many of these claims are quality cases that have high settlement value. If you have experienced transvaginal mesh side effects or complications with a vaginal mesh sling and feel you may be entitled to monetary damages for your injuries, fill out our free case review form or call Laura Zois at 800-553-8082.

More Information on Vaginal Mesh Lawsuits.

• Journal of Obstetrics and Gynecology Article (article summary)
• The Journal of Urology Study (summary of one of the key studies)