What is Vaginal Mesh?
Vaginal mesh, including bladder slings and ObTape, is a surgically implanted medical device that is used to repair weakened or damaged pelvic tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material.
Vaginal mesh is used most often to specifically treat two conditions that many women suffer from: (1) Pelvic Organ Prolapse (POP) which occurs when the tissues that hold the pelvic organs become weakened or stretched. 30-50% of women may experience POP in their lifetime; (2) Stress Urinary Incontinence (SUI) which is the involuntary loss of urine during periods of increased abdominal pressure. This includes physical activity such as coughing, sneezing, laughing, and/or exercising.
Vaginal Mesh Lawsuits: A Brief History
Since 1998, physicians across America have been allowed to use vaginal mesh (TVM) to correct stress urinary incontinence (SUI) and prolapse of the pelvic organs (POP). It was marketed as a less invasive alternative to the procedures that were currently approved which did not include any foreign body implant to correct the SUI and/or POP.
Unfortunately, at the expense of the patient, the pathway toward FDA clearance was corrupted through corporate greed and lack of oversight which lead to the catastrophic injuries suffered by thousands of women who were misinformed of the dangers of having vaginal mesh surgically implanted within their body.
In 1997 the FDA gave approval to Ethicon (Johnson & Johnson) for a new medical implant called Ethicon PROLENE. It was granted approval under what is known as 510(k) which does not require clinical trials because the properties of the device were considered “identical” to a device that had already been FDA approved. The intended use for this product was for repair of indirect or direct inguinal hernia defects.
The following year, the FDA gave another 510(k) approval for Tension Free Vaginal Tape (TVT) which was composed of PROLENE. The intended use of TVT was for treatment of SUI. The TVT implant was “identical” to the composition of PROLENE, however the placement of the implants were far from “identical”. The physiological mechanisms of immunity reactions toward foreign body implants vary greatly between body cavities.
“Based on data from 110 studies including 11,785 women, approximately 10 percent of women undergoing Pelvic Organ Prolapse (POP) repair with vaginal mesh experienced mesh erosion within 12 months of surgery.”
Vaginal Mesh Complications & Side Effects
“Vaginal mesh-associated complications are not rare.” The most commonly reported vaginal mesh complication and injury is Vaginal Mesh Erosion. According to recent Food and Drug Administration (FDA) studies, the most common vaginal mesh complications and side effects include:
- Vaginal Mesh Erosion through the vaginal wall is the most common and consistently reported vaginal mesh injury. Vaginal mesh erosion, or exposed mesh, can cause organ perforation, extreme pain, and discomfort.
- Vaginal Mesh Contraction, or shrinkage, may cause vaginal shortening, vaginal tightening, and intense vaginal pain.
- Both vaginal mesh erosion and contraction can lead to infection, urinary problems, recurrence of prolapse, and incontinence.
- Both vaginal mesh erosion and contraction may lead to severe pelvic pain, painful sexual intercourse (dyspareunia) or the inability to engage in sexual intercourse.
Your Potential Vaginal Mesh Lawsuit
If you’ve had vaginal mesh surgically implanted and have suffered an injury, infection, or other painful side effect, whether corrective surgery was required or not, then you may qualify to receive substantial financial compensation for your pain and suffering.
Complete the form to the right to submit your vaginal mesh lawsuit claim which will be reviewed by one of our medical nurses.
According to a recent FDA study, the most common and consistently reported vaginal mesh injury and complication is mesh erosion through the vaginal wall. Vaginal mesh erosion can cause infection, organ tissue damage, as well as extreme pain and discomfort which typically requires multiple surgeries to correct.
If you are one of the thousands of women who has suffered from a vaginal mesh implant, then we urge you to complete and submit the vaginal mesh injury claims form to the right, or call 1.800.2519 for a free legal consultation.
You are not alone. We will work diligently on your behalf to ensure that you receive the compensation that you deserve for your pain and suffering.
MDL Consolidated Vaginal Mesh Lawsuits
Vaginal mesh lawsuits have been consolidated into (5) separate Federal multi-district litigations (MDL). The jurisdiction for all (5) fall under the United States District Court in the Southern District of West Virginia. These vaginal mesh lawsuits involve complaints against (5) vaginal mesh, bladder sling, and ObTape manufacturers:
- C.R. Bard:
- Pelvitex, Pelvisoft, Pelvilace, Pelvicol
- Urtex, +similar
- Johnson & Johnson (Ethicon/Gynecare):
- Prolift, Prosima
- TVT Exact, Abbrevo, Retropubic, Obturator, Secur, +similar
- American Medical Systems (AMS):
- MiniArc, Monarc, In-Fast, BioArc
- Sparc, Elevate, Perigree, Apogee, +similar
- Boston Scientific:
- Arise, Pinnacle, Advantage
- Lynx, Obtryx, Prefyx, Solyx, +similar
- Mentor ObTape
- Caldera Medical
Many women who have received vaginal mesh implants have required at least one corrective surgery to correct mesh erosion, constriction, contraction, infection, organ perforation (soft tissue puncturing), urinary incontinence, pelvic pain, recurrence of prolapse, as well as many additional vaginal mesh complications, injuries, and side effects.
“In 2011, the FDA issued a public warning which stated that serious complications from vaginal mesh devices are ‘not rare.’”
About the Vaginal Mesh Lawsuit Attorneys
Carey Danis & Lowe (CD&L) is not a marketing firm. Carey Danis & Lowe is a National, plaintiff’s litigation law firm that focuses primarily on complex litigation including pharmaceutical product liability, personal injury, and defective medical device litigation. CD&L has recovered more than one billion dollars for their clients. These results have been both nationally recognized verdicts and monumental settlements on behalf of thousands of injured clients. [Read More]
Carey Danis & Lowe will work with you and your family from beginning to end.
CD&L understands the sensitive nature of these cases and will work with you throughout the entire settlement process. CD&L wants your vaginal mesh lawsuit to settle quickly and as easily as possible, and they will work diligently to ensure that you receive the compensation that you deserve.
Carey Danis & Lowe is committed to exposing the dangers of vaginal mesh implants and pursuing justice on behalf of all those who have been needlessly harmed.