Products Liability
Our lawyers are investigating vaginal mesh and bladder sling lawsuits involving Gynecare (Ethicon) Prolift, Bard Avaulta, AMS, and other manufacturers of vaginal mesh systems.
Overview of Mesh/POP Lawsuits
You don’t hear a lot about vaginal prolapse. It is incredibly common. Approximately 30-50% of women have some sort of vaginal prolapse during their lives. Simply put, there is a network of muscles, ligaments, and skin in and around the vagina.
Many women have a claim but just can’t decide if they want to bring one. We understand. You can get our thoughts on your choice here.
This network acts as a complex support structure that holds pelvic organs, tissues, and structures in place. If the network is weakened, elements of the support system may eventually weaken or break. This is called vaginal prolapse.
One solution when the problem reaches a critical mass with patients: is synthetic mesh devices (also referred to as tapes or slings) that are generally made of polypropylene. In the past few years, the FDA has received nearly 4,000 reports of complications associated with mesh devices used in pelvic organ prolapse repair. Complications include erosion through the vaginal walls, pain, painful sexual intercourse, or the inability to have intercourse. Complications of surgical mesh implantation can be debilitating and have not been linked to a single brand of mesh. Though sexual problems often result from pelvic organ prolapse, implantation of vaginal mesh devices have also been reported to result in sexual dysfunction in women, especially concerning increased reports of dyspareunia (painful intercourse).
Over 75% of women receiving surgery for pelvic organ prolapse are postmenopausal. Menopause brings about many changes including estrogen deficiency which results in changes to vaginal pH, overactive bladder, dryness, and painful sexual intercourse. Though pelvic organ prolapse surgery can correct the process of prolapse, it can negatively impact sexual function.
Results of the Studies
A study was recently published which was conducted on 69 women who underwent transvaginal mesh surgeries for pelvic organ prolapse. All women studied were sexually active and menopausal. Subjects completed an FSFI questionnaire (a questionnaire designed and validated to assess female sexual function). The questionnaire is designed to evaluate six domains: sexual desire; sexual arousal; lubrication; orgasm; satisfaction; dyspareunia (pain). The questionnaire was completed before and 6 months post-surgery. Post-operative scores were compared to pre-operative questionnaire scores. Though there were no significant changes in sexual desire, sexual arousal, orgasm, or satisfaction, scores for lubrication and dyspareunia worsened. Further, 66.7% of patients studied had lower FSFI scores post-operatively.
Another study conducted on 36 premenopausal and 32 postmenopausal women reported that one-third of premenopausal women studied had worsening sexuality domain after an operation with transvaginal mesh and a higher rate of dyspareunia (painful intercourse) compared to postmenopausal women.
Results of these studies suggest that regardless of menopausal status, adverse effects concerning sexual function may result from transvaginal mesh surgeries. The wide dissection which occurs during transvaginal mesh implant operations may lead to nerve damage resulting in vaginal wall congestion and lubrication alterations and ultimately lead to impairment of sexual function. The use of synthetic materials in mesh implant surgeries may result in dyspareunia, dryness, and other problems, especially in cases where the mesh erodes the vaginal wall.
Although sexual dysfunction is highly prevalent in women and is estimated to surpass male sexual dysfunction, it receives less attention than for male counterparts. Sexual dysfunction in women can be debilitating and often results in a negative impact on social and emotional well-being and can result in relationship problems with partners, leading to impaired quality of life for these women.
The purpose of pelvic mesh products is to provide support for prolapsed pelvic organs (POP) and urinary incontinence (SUI) that comes with weakened muscles due to childbirth, age, or other causes. These lawsuits claim the vaginal mesh manufacturers failed to make a safe product. These bladder slings did not go through full clinical trials and instead snuck on the market by the Section 510(k) exception that these vaginal mesh implants were substantially equivalent to other similar products already on the market.
Being a Plaintiff in These Lawsuits: Your Choice
Patients in these cases are in a tough spot. They had a problem that caused them embarrassment and got to the point where they reached out for a solution. Now the solution is worse than the original problem itself. The reason why this happened, plaintiffs’ lawyers and victims argue: no one tested these products to make sure they were safe.
On top of all of this, women are now uncomfortable bringing a claim against these vaginal mesh manufacturers because they want to protect their privacy. But, as the settlements we have already seen have shown, these may be very valuable cases. Some women are just never going to bring a claim. We get that. But just keep in mind: these cases are sitting in another jurisdiction. The majority of women who have claims never meet their lawyers, much less find themselves in court. Could that happen? Of course, it could. But it is unlikely in mass tort cases like these vaginal mesh lawsuits. Ultimately, you need to make your own choice as to what is best for them. If you just want more information, you can get that by making a confidential online inquiry or calling 800-553-8082.
Types of Vaginal Mesh Lawsuits
We are looking at the following types of vaginal mesh cases:
- 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
If you have experienced transvaginal mesh side effects and feel you may be entitled to money damages for your injuries, fill out our free case review form or call us at 800-553-8082. Again, this may be just getting information; it is not a decision to bring a claim or file a lawsuit.
Mentor OB Tape
According to a study Journal of Obstetrics and Gynaecology reports on a study involving f31 patients undergoing TOT (Obtape (R)) from April 2005 to April 2006, The patients were sent a questionnaire. All patients had significant stress incontinence. One patient had a urinary tract infection and, another had catheterization for 5 days. A total of 16.6% of patients developed sling erosion. There was a 93% response rate to the postal survey, indicating a 31% complete cure of urinary incontinence; 65% significant improvement, and 3.5% failure. Urge incontinence disappeared in 66%, with no de-novo urgency and 8% reported slower voiding. Satisfaction was 8.9 on a 1 – 10 Scale.
In other words, the Obtape helped most patients but the erosion rate for a minority of Obtape users suffered a significant complication. The researchers concluded: “The success rate of the TOT procedure was high, helping both stress and concomitant urge incontinence, but due to an unacceptably high erosion rate, Obtape (R) was discontinued.”
If you or someone you love has suffered injuries and would like to learn more about the Mentor ObTape Sling lawsuits that are pending around the country, call 800-553-6000 or click here for a free confidential case evaluation by a Mentor ObTape Sling lawyer.
More Information
- Lawsuit Information (background and update on Mentor TOT lawsuits)
- Another Obtape Study (a less critical study of Mentor Obtape that showed a vaginal mesh erosion rate in 6.2% of women in the study)
Vaginal Sling Litigation Update
Surgical mesh implants have been used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). What the mesh does is strengthens or repair the weakened muscles to treat POP, or it supports the pelvic muscles surrounding the urethra or bladder to repair SUI. When the mesh is used to treat SUI, it is commonly known as a bladder sling.
While mesh implants were seen as safe and conventional treatments, in 2011, the FDA issued its first warning against vaginal mesh implants for POP. The FDA noted adverse effects such as mesh erosion and mesh contraction (shrinkage). Both mesh erosion and mesh contraction can cause severe pelvic pain and pain during sexual intercourse. Mesh erosion and mesh contraction require multiple surgeries to repair the problem. To make matters worse, it s not as if the FDA issued its warning against a certain brand or type of mesh, but these adverse effects were seen with all mesh implants.
VAGINAL MESH CLAIM UPDATE
In 2012, the FDA updated its warning again. Based on reports received by the FDA citing adverse effects of mesh implants and evaluation of published research and studies, the FDA was considering reclassification of surgical mesh from Class II to Class III. Class III products are those that present the greatest risks and require greater regulation from the FDA. The FDA ordered studies from manufacturers of surgical mesh devices for POP and SUI. The FDA’s assessments are still ongoing.
It is important to remember though that woman with mesh implants for POP or SUI may suffer other adverse effects that the FDA did not mention. Along with pelvic pain, transvaginal mesh injuries can also affect simple daily activities, like sitting or walking. It can also take a toll on a woman’s physical and emotional well-being, professional life, and relationships with family, friends, or partners.
Plaintiffs Get Good Rulings
There have been two recent developments for plaintiffs in 2013. First, the judge is coming down hard on defendants who are trying to find creative ways to stop plaintiffs’ counsel from getting to the truth. The court ruled that American Medical Systems, one of the defendants, must provide two former employees to plaintiffs’ lawyers for deposition. Why does this matter? Former employees are the first to speak the real truth. In another ruling Ethicon/Johnson & Johnson was required to make a witness available to speak to J&J’s procedures and practices related to all five of their products at issue.
AMS Settles Some Cases
There have also been some more settlements. Endo Health/American Medical Systems will pay $54.5 million to settle some of these claims. Not all of the cases will fall into this settlement, and it is expected that this small manufacturer will still have to pay out another $100 million. At least.
Big Verdict
The other big development this year was the big verdict back in February of $11.1 million. This verdict will have a big impact on the amount of money paid to settle these claims in the long run. Because is said the jury not only find liability, it was mad. This means something both regarding dollars and cents and in terms of public relations for these companies.
The Vaginal Mesh Lawsuits
Several lawsuits are pending around the country because of the pain and suffering caused by mesh implants. The first case that went to trial over a mesh implant was in California in 2012. The jury decided that C.R. Bard. Inc, the manufacturer of the Avaulta mesh implant product [more on Avaulta cases], and a doctor would pay $5.5 million in damages to a woman whose vaginal mesh implant left her incontinent and suffering chronic pain. This case is hopefully an indicator of how the thousands of pending cases may turn out.
Because so many cases involving mesh implants were being filed against manufacturers, thousands of cases were consolidated into separate multidistrict litigation groups [what is an MDL?] before the U.S. District Court for the Southern District of West Virginia. The first trial date for about 600 cases against Avaulta was set for February 5, 2013, in West Virginia. A fifth MDL, involving hundreds of lawsuits over the defective Mentor ObTape (a vaginal sling product from Johnson and Johnson), was assigned to the U.S. District Court for the Middle District of Georgia and is also making headway. Most recently in the Mentor ObTape MDL, the plaintiffs gained a victory when the judge denied the defendant’s motion for summary judgment. In state court, New Jersey is currently hearing its first trial out of more than 1,900 cases filed against Johnson and Johnson’s Ethicon brand.
These first cases to go to trial will shed light on the extent of pain and suffering caused by mesh devices and will also highlight how manufacturers failed to adequately test their products for safety and failed to research the risks involved.
Types of Vaginal Mesh Lawsuits
We are looking at potential lawsuits for the following transvaginal mesh manufacturers:
- Bard Avaulta Support System
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- ARMSElevate Prolapse Repair
- Apogee Vault Suspension
- Perigee
- Monarc Sling System
- Sparc Sling System
- Boston Scientific
- Pinnacle Pelvic Floor Repair Kit
- Boston Scientific Uphold Vaginal Support
- Ethicon Gynecare (Johnson & Johnson)
- Gynemesh
- Prolene Soft Mesh
- Prolift Pelvic Floor Repair System
- TVT Transvaginal Sling
- Mentor OB Tape
- UGYTEX Dual Knit Mesh
- Covidien IVS Tunneler Sling
If you have experienced transvaginal mesh side effects and feel you may be entitled to money damages for your injuries, fill out our free case review form or call us at 800-553-8082. Again, this may be just getting information; it is not a decision to bring a claim or file a lawsuit.
More Vaginal Implant Lawsuit Information
- The Big Picture: What are these claims really about?
- Example vaginal sling malpractice lawsuit
- Free Consultation (free evaluation of your case at 800-553-8082 or online)
Avaulta Vaginal Mesh Lawsuits Against C.R. Bard
Pelvic organ prolapse (“POP”) occurs when the muscles and ligaments supporting a woman’s pelvic organs weaken and slip out of place. Because of the sensitivities involved, there is very little talk about this issue in the media or even in private conversation. But it is a very common problem. Approximately 50% of women – a statistic few people seem to focus on – who have children will suffer some type of prolapse ovthroughoutheir lives and nearly 10% of women will need surgery for pelvic organ prolapse.
Vaginal mesh implants were seen as a revolution in dealing with POP, helping women avoid more invasive retropubic placement. The idea of vaginal mesh implants was conceived in France in the late 90s and requires the placing of a sling via the groin and obturator foramen of the bony pelvis. The first European product was a polypropylene mesh with a silicone-coated sub-urethral zone called Uratape. Uratape failed and was withdrawn from the market because of a high incidence of vaginal mesh extrusion and replaced with ObTape. But Mentor’s ObTape and Avaulta’s vaginal mesh slings, the two big replacements for Uratape, were not much of an improvement.
The Avaulta vaginal sling consists of a thermally linked monofilament polypropylene fiber with small pores. The Avaulta pelvic sling is non-woven which makes it relatively stiff. The Avaulta lawsuits claim the mesh users have suffered an erosion of the mesh into the vaginal wall causing tearing, cutting, and sometimes permanent erosion of the vaginal tissues at levels that are unacceptable, and that its manufacturer should have known about from the Uratape example. The lawsuits also claim the product needed more testing and analysis before Avaulta put its sling on the market.
Thousands of women remain implanted with vaginal mesh implants and suffer from or are at risk of suffering from vaginal mesh extrusion. Avaulta transvaginal pelvic 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.
Trial
A New Jersey state court jury awarded a total of $68 million to a woman who sued Bard claiming that she was harmed by Bard Medical’s Align and Avaulta transvaginal mesh products.
Doctors implanted the mesh in 2009 to treat stress urinary incontinence and pelvic prolapse. The jury was hard on C.R. Bard. They found both”malicious intent” or “wanton and willful disregard” in selling these devices despite the risks undisclosed risks to women.
While many of these lawsuits have settled, there are still many pending, including over 100 claims in New Jersey state court alone.
Our firm is not reviewing new vaginal mesh cases.