Transvaginal Mesh Devices

Transvaginal mesh and transvaginal mesh patches are woven mesh implants that stretch across the vaginal wall to support damaged tissue or prolapsed organs. The surgical mesh implant, which is made of woven mesh fibers, has been used to treat both Pelvic organ prolapse (POP) and Stress Urinary Incontinence (SUI) in women. These implants have led to serious complications like infection, pain, urinary problems and bowel, bladder and blood-vessel perforations.

FDA Public Health Notification

The FDA has received reports of complications associated with the placement of mesh through an incision made in the wall of the vagina. Following is a FDA public health notice issued on October 20, 2008 stating:

“Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI.”

Complications from the Mesh:

Erosion through the vagina (vaginal epithelium)
Infection
Pain
Urinary problems
Recurrence of prolapse and/or incontinence
Bowel, bladder, and blood vessel perforation during insertion
Dyspareunia (pain during sexual intercourse)
Scarring
Narrowing of the vaginal wall (in POP repair).
In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain

Corrective Measures

Some patients needed additional surgery to remove the mesh that had eroded into the vagina. Other corrective measures include:

Additional surgical procedures
IV therapy
Blood transfusions
Drainage of hematomas or abscesses

Are you at Risk?

Specific characteristics of patients at increased risk for complications have not been determined and the complications have not been linked to any one particular brand or model of mesh.

Contributing factors may include:

Overall health of the patient
Mesh material
Size and shape of the mesh
Surgical technique used
Concomitant procedures undertaken (e.g. hysterectomy)
Estrogen status

Transvaginal Mesh Brands

If are experiencing adverse symptoms from your transvaginal mesh implant, contact your doctor for an appointment as soon as possible. Don’t forget to ask which brand of transvaginal mesh device you have been given. The following are transvaginal mesh brands:

Bard

Avaulta Plus BioSynthetic Support System
Avaulta Solo Synthetic Support System
Faslata Allograft
Pelvicol Tissue
PelviSoft Biomesh
Pelvitex Polypropylene Mesh

American Medical Systems

SPARC

Boston Scientific

Advantage™ Sling System
Obtryx® Curved Single
Obtryx® Mesh Sling
Prefyx Mid U™ Mesh Sling System
Prefyx PPS™ System

Johnson & Johnson

Ethicon TVT
Gynecare TVT
Gynemesh PS
Prolene Polypropylene Mesh Patch
Secur

Mentor Corporation

ObTape

Sofradim

Pelvetex Polypropylene Mesh Patch
Uretex Pubovaginla Sling
Uretex Pubovaginla Support Kit
Uretex TO Avaulta BioSynthetic System

Caldera

T-Sling

About Pelvic Disorders

According to the Food and Drug Administration (FDA) Pelvic organ prolapse and stress urinary incontinence are pelvic disorders affecting millions of women in the United States. They occur when pelvic floor muscles lose strength, allowing pelvic organs, including the bladder and uterus, to descend from their normal location and bulge through the vaginal wall (pelvic organ prolapse), or diminishing bladder control (stress urinary incontinence).

Experienced Defective Medical Device Attorney

Thomas J. Henry Injury Attorneys are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/ or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side effects from the use of transvaginal mesh or transvaginal mesh patches, contact Thomas J. Henry Injury Attorneys immediately. We are available 24/7, nights and weekends.

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