 Females who have had a vaginal mesh patch device implanted could be at risk for a number of internal injuries including infection, urinary problems, and other complications resulting in severe pain and discomfort.
Free Confidential Case Review: If you or a loved one has been injured by a defective transvaginal mesh patch device, contact us as soon as possible for a free confidential review of your potential case, or to click “Free Case Review” link on below to submit your claim securely online.
The Law Office of Derriel C. McCorvey, LLC is reviewing cases involving complications by women associated with transvaginal surgical mesh for Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (SUI). Call us today at 1-888-291-2431 for a free case evaluation if you are experiencing complications associated with transvaginal surgical mesh.
What is Transvaginal Surgical Mesh?
Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material. In urogynecologic procedures, surgical mesh is permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence.
Pelvic Organ Prolapse
Pelvic Organ Prolapse (POP) occurs when the tissues that hold the pelvic organs in place become weak or stretched. Thirty to fifty percent of women may experience POP in their lifetime with 2 percent developing symptoms. When POP happens, the organs bulge (prolapse) into the vagina and sometimes prolapse past the vaginal opening. More than one pelvic organ can prolapse at the same time. Organs that can be involved in POP include the bladder, the uterus, the rectum, the top of the vagina (vaginal apex) after a hysterectomy, and the bowel.
Stress Urinary Incontinence
Stress Urinary Incontinence (SUI) is a leakage of urine during moments of physical activity, such as coughing, sneezing, laughing, or exercise.
FDA Public Health Notification on Transvaginal Mesh Devices
In 2008, the FDA published an urgent public health notification regarding the serious complications associated with transvaginal placement of surgical mesh in repair of POP and SUI. To date, the administration has received well over 1,000 reports about serious complications related to the placement and use of these devices.
How many varieties of transvaginal mesh products are there?
Manufacturers of transvaginal mesh products include:
Johnson & Johnson:
- Ethicon TVT
- Gynecare TVT
- Gynemesh PS
- Prolene Polypropylene Mesh Patch
- Secur
Bard:
- Avaulta Plus BioSynthetic Support System
- Avaulta Solo Synthetic Support System
- Faslata® Allograft
- Pelvicol® Tissue
- PelviSoft® Biomesh
- Pelvitex Polypropylene Mesh
American Medical Systems (AMS):
Boston Scientific:
- Advantage Sling System
- Obtryx® Curved Single
- Obtryx® Mesh Sling
- Prefyx Mid U Mesh Sling System
- Prefyx PPS System
Summary of Problem and Scope
In the Oct. 20, 2008 FDA Public Health Notification, the number of adverse events reported to the FDA for surgical mesh devices used to repair POP and SUI.
In particular, FDA Public Health Notification revealed that:
- Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.
- Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
- There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.
- While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.
For detailed information, please see the FDA Notification here.
Call us today for a free case evaluation at 1-888-291-2431.
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