Women Implanted with Transvaginal Mesh Suffer from Painful, Permanent Injuries;
Millions of women have received a transvaginal mesh implant or mesh sling to help repair pelvic organ prolapse (POP) or stress urinary incontinence (SUI). POP occurs when the organs in the pelvis slide out of place and SUI is the involuntary release of urine during activities such as sneezing or coughing. These conditions may severely impact quality of life. Transvaginal mesh is meant to help correct POP and SUI by providing the pelvic organs and muscles with extra support; however, these devices have been linked to a high rate of serious complications.
POP occurs when the muscles and tissue of the pelvic floor become stretched, torn, or weakened and can not support pelvic organs, including the bladder, bowel or uterus. When this happens, the organs drop from their normal position and prolapse (bulge) into the vagina. Women with POP typically experience low back pain or pelvic pressure, painful intercourse, or constipation or urinary problems that include leakage or a chronic urge to urinate.
Doctors may perform POP surgery for women with significant symptoms may use a minimally invasive transvaginal technique to reduce recuperation time. The surgical mesh may be permanently implanted during this surgery to reinforce the weakened pelvic floor muscles and repair POP; however, over the past several years the FDA has received thousands of reports of vaginal mesh complications in POP repairs.
The personal injury attorneys at Parker Waichman are investigating alleged injuries associated with transvaginal or pelvic mesh devices. The firm is currently offering free lawsuit evaluations to individuals allegedly injured by these transvaginal/pelvic mesh devices.
Safety Issues with Transvaginal Mesh
Surgical mesh has been used by surgeons since the 1950s for the repair of abdominal hernias. In the 1970s, gynecologists began implanting surgical mesh for the abdominal repair of POP and, in the 1990s, for the transvaginal repair of POP. In 2002, the first mesh device with this indication was cleared for use as a class II moderate-risk device. At least five device makers currently market this product.
In 2008, the U.S. Food and Drug Administration (FDA) released a Safety Communication warning that complications associated with pelvic mesh were rare, but serious. "The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia," the agency wrote.
In 2011, the FDA released an update on its previous announcement, indicating that complications associated with transvaginal mesh were "not rare." This warning is different from what the agency communicated back in 2008. Additionally, the FDA cautioned that transvaginal mesh does not appear to have clear benefits for POP repair when compared to non-mesh methods. In fact, using transvaginal mesh for POP may actually pose greater risks, the alert indicated.
Specifically, on July 13, 2011, the FDA indicated in a Safety Communication that complications associated with transvaginal mesh implants are "not rare" and that there is no conclusive evidence showing that transvaginal mesh is more effective than non-mesh repairs in all patients with POP. In fact, the agency indicated that the mesh device "may expose patients to greater risk." The FDA also indicated that it had received 2,874 new reports of complications linked to transvaginal mesh between January 2008 and December 2010. Of these, 1,503 were associated with POP repairs and 1,371 with SUI repairs. Studies reviewed by the agency reveal that about 10 percent of women who have undergone a transvaginal mesh implant experience erosion (meaning the mesh cuts through their bodies tissues) within 12 months of surgery; more than half required additional surgery to remove the mesh. In some cases, even multiple surgeries did not resolve complications.
On August 25, 2011, the watchdog group Public Citizen, founded by Ralph Nader, announced that the FDA should recall transvaginal mesh products due to safety concerns and painful side effects. The FDA itself indicated in an Executive Summary released August 31, 2011 that it "believes that vaginal placement of surgical mesh for Pelvic Organ Prolapse (POP) repair inherently introduces risks of complications that are unique to the mesh itself."
During a meeting convened by the FDA on September 8 and 9, 2011, a majority of the Obstetrics and Gynecology Medical Device advisory panel agreed that the safety, effectiveness, and that the benefits of transvaginal mesh devices in POP repair are not well established and warrants long-term prospective follow-up of patients. The agency proposed reclassification of mesh devices used in the repair of POP from Class II to Class III. This would mean that surgical mesh for POP repair would no longer be able to receive clearance through the FDA's less stringent 510(k) approval route, and manufacturers would have to conduct clinical trials to prove that their products are safe and effective.
Studies reviewed by the FDA found that roughly 10 percent of women who undergo surgery with transvaginal mesh will suffer from mesh erosion within 12 months. Other complications linked to the mesh implants include:
- Chronic vaginal damage, discharge, and infections
- Exposure or extrusion of mesh, in which mesh moves through vaginal tissue
- Feeling a lump in the opening or something protruding from the vagina
- Mesh erosion through the vagina (also called exposure, extrusion, or protrusion)
- Painful sexual intercourse (dyspareunia)
- Perforation of the bladder, intestines, bowels, and blood vessels around the vaginal wall
- Recurring POP
- Recurring SUI
- Urinary problems
- Vaginal bleeding
- Vaginal pain
- Vaginal scarring and shortening
One of the major complaints cited in vaginal mesh personal injury lawsuits is that transvaginal mesh implants were approved without any clinical testing for safety or efficacy. Pelvic mesh was approved through the 510(k), a regulatory route that allows manufacturers to gain approval without clinical testing if they can show that their products are "substantially equivalent" to a previously approved product (also known as a so-called "predicate" device).
In light of injury reports and mounting litigation over transvaginal mesh implants, many have criticized the fact that device makers were allowed to gain approval through lax regulations and say that transvaginal mesh should have been a Class 3, or "high risk" device, which is not allowed to go through 510(k) regulatory clearance.
FDA Proposes Upgrade to Transvaginal Mesh Device Classification, Pre-Market Device Approval
The FDA issued two proposed orders in April 2014 that were meant to address the health risks often seen when surgical mesh is used in the transvaginal repair of POP. If the agency's proposed orders are finalized, a re-classification of surgical mesh and the surgical instruments used in transvaginal repair of POP would be upgraded and the makers of these devices would be required to submit pre-market approval (PMA) applications to the FDA for safety and efficacy evaluation.
According to William Maisel, MD, MPH, deputy director of science and chief scientist at the FDA's Center for Devices and Radiological Health, "The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products." Dr. Maisel added, "If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair."
The re-classification involves the mesh used in transvaginal repair of POP being changed from Class II (moderate risk) to Class III (high risk) and a re-classification of urogynecologic mesh instrumentation being changed from Class I (low risk) to Class II, as well as the establishment of special controls for surgical instrumentation when used with urogynecologic mesh.
The PMA change would mean that the devices would not longer be able to be cleared through the FDA's 510(k) process and would be required to undergo pre-market approval, which would empower the agency to conduct safety and efficacy evaluations on the surgical mesh used in transvaginal POP repair. The 501(k) process has drawn increasing criticism due to the release of a number of controversial medical devices, including transvaginally implanted pelvic mesh.
FDA Issues Final Orders Over Transvaginal Mesh
On January 4, 2016, the FDA issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair POP transvaginally or vaginally. The agency issued one order to reclassify these medical devices from class II to class III. The second order mandates manufacturers to submit a PMA application to support the safety and efficacy of surgical mesh for POP transvaginal repair. Both orders will mandate manufacturers to address safety concerns, such as severe pelvic pain and organ perforation, through a rigorous PMA pathway to demonstrate safety and efficacy. The actions apply only to mesh devices marketed for the transvaginal repair of POP. These orders do not apply to surgical mesh for other indications such as SUI or abdominal repair of POP.
"These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse," said William Maisel, M.D., M.P.H., deputy director of science and chief scientist for the FDA's Center for Devices and Radiological Health. "We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures."
The makers of surgical mesh to treat POP transvaginally have 30 months-as mandated by federal law-to submit a PMA for devices that are already on the market. Those manufacturers of new devices will have to submit a PMA before the devices may be approved for marketing. Manufacturers may choose to submit a PMA prior to the 30-month deadline.
Transvaginal Mesh Lawsuits
Thousands of cases have been filed in the U.S. District Court for the Southern District of West Virginia over transvaginal mesh implants. Five multidistrict litigations (MDLs) were pending in that court against Ethicon/Johnson & Johnson, Boston Scientific, C.R. Bard, American Medical Systems, and Coloplast over their pelvic mesh implants. Several manufacturers of transvaginal mesh (TVM) and sling devices have been involved in lawsuits, specifically:
- American Medical Systems: sold under the names Elevate, Perigee and Apogee
- Boston Scientific: sold under the names Advantage Transvaginal Mid-Urethral Sling System, Pinnacle Posterior Pelvic Floor Repair Kit, Obtryx Transobturator Mid-Urethral Sling System, Polyform Synthetic Mesh, Prefyx Mid U Mesh Sling System, Prefyx PPS System, Uphold Vaginal Support System
- C.R. Bard, Inc.: sold under the names Avaulta, Pelvisoft BioMesh, Pelivicol Acellular Collagen Matrix, Pelvitext, and Pelvilace
- Johnson & Johnson/Ethicon: sold under the names Gynecare, Gynemesh, Gynecare Prolift, Gynecare Prolift + M, Gynecare Prosima, and Gynecare TVT
Victims of vaginal mesh implant and sling failures who file a transvaginal mesh lawsuit may be compensated for the following:
- Additional surgery and multiple revision surgeries
- Emotional distress
- Loss of ability to have sexual relations, loss of consortium on behalf of spouse
- Loss of quality of life
- Lost wages
- Out-of-pocket medical, surgical, and hospital expenses
- Pain and suffering
As increasing evidence emerges about safety issues with transvaginal mesh devices, it is expected that the litigation surrounding these products will continue to grow.
Johnson & Johnson Unit, Mentor Corp., Reaches Settlement in Pelvic Mesh Case
Mentor Corp., a unit of Johnson & Johnson, accused of making defective pelvic mesh implants that cause painful infections has reached a settlement just weeks before a bellwether trial was scheduled to begin, on November 30, 2015.
Law360 reported that Mentor Corp. filed settlement documents in Georgia federal court in early November 2015, settling a case involving the company's ObTape vaginal sling. Mentor Corp. was accused of making defective pelvic mesh implants that cause painful infections and other complications.
In the ObTape cases, Mentor faces claims of negligence, fraudulent concealment, breaches of express and implied warranties, and failure to warn. The woman in the settled case was implanted with the ObTape device in 2004. By 2011, she alleged to have suffered infections, abscesses, and scarring that required multiple surgeries, according to Law360.
This case was one of hundreds brought against Mentor that were consolidated in a multidistrict litigation (MDL). Mentor settled another proposed bellwether case in July 2013 shortly before trial.
A bellwether trial is one in which the claims are similar to claims made in a number of other cases. To manage the large caseload, the parties choose a group of plaintiffs to represent all of the plaintiffs. The representative cases are sent to trial first; the results of the bellwether cases may indicate trends in the litigation. Bellwether cases often provide the basis for reaching a settlement in other cases.
Johnson & Johnson Unit, Ethicon Division, Transvaginal Mesh
Johnson & Johnson's Ethicon division makes a number of transvaginal mesh devices, which are used to treat POP and SUI. Many women allege that the mesh only made their lives worse. One of the most common complaints involves the mesh allegedly moving and cutting through the vaginal and pelvic tissues, causing immense pain. Surgery is performed to remove the mesh; however, in some cases, scar tissue has formed around the mesh, making it extremely difficult to remove. Some women have required multiple surgeries and still have found no relief.
Johnson & Johnson's Ethicon Unit Stops Selling Four Transvaginal Mesh Devices
On June 4, 2012, Johnson & Johnson's Ethicon division stopped selling four types of transvaginal mesh implants. In a letter filed with the U.S. District Court for the Southern District of West Virginia, the company indicated that it had asked the FDA for approval to stop selling the following devices:
- Gynecare TVT Secur system
- Gynecare Prosima
- Gynecare Prolift
- Gynecare Prolift + M
There is overwhelming evidence suggesting that transvaginal mesh devices are unsafe. For example, the FDA has reported a five-fold increase in injury reports related to the implants between 2008 and 2010. Despite the growing evidence, however, Ethicon and Johnson & Johnson claim that the decision to stop selling the mesh products had to do with commercial viability and not safety issues.
Jury Awards Woman $11.1 Million in Ethicon Vaginal Mesh Case Against J&J
In February 2013, Johnson & Johnson and Ethicon lost the first of some 4,000 Gynecare Prolift cases to go to trial. The jury awarded the plaintiff a total of $11.1 million; $3.35 million in compensation for her injuries, and $7.76 million in punitive damages against J&J.
J&J to Settle Vaginal Mesh Lawsuits for $120 Million
For the first time, in January 2016, J&J agreed to settle a large number of transvaginal mesh lawsuits. The company agreed to pay $120 million to resolve 2,000 to 3,000 vaginal mesh lawsuits alleging that the mesh inserts are defective and led to severe injuries. The vaginal mesh settlement only resolves a fraction of the 46,000 lawsuits filed, as of January 2016.
Plaintiffs in the vaginal mesh lawsuits against Ethicon have similar allegations. Alleged injuries include mesh erosion, in which the mesh moved through the tissues of the vagina, leading to organ damage, pain, bleeding, painful sex, difficult urination, and other complications. Many women suing over vaginal mesh side effects also allege that they underwent several surgeries to treat their injuries, often without success.
Other manufacturers, including C.R. Bard and Boston Scientific, are also being sued over transvaginal mesh implants. Litigation began mounting in 2011, and now more than 100,000 mesh lawsuits have been filed.
C.R. Bard Transvaginal Mesh Litigation Involves Covidien Subsidiaries
Transvaginal mesh device maker, C.R. Bard, has been supplied with pelvic mesh products manufactured by two Dublin, Ireland-based Covidien subsidiaries.
In its July 2014 filing with the U.S. Securities and Exchange Commission (SEC), Covidien indicated that it had taken a $180 million charge against third-quarter earnings to cover costs associated with pelvic mesh litigation. According to reports, the charge followed discussions with plaintiffs' attorneys regarding possible settlements. Covidien also indicated that it intends on indemnifying Bard from certain claims and will cover the losses. According to the SEC filing, "The litigation includes a federal multi-district litigation in the United States District Court for the Northern District of West Virginia and cases in various state courts and jurisdictions outside the United States."
In fact, C.R. Bard has been named in federal litigation in which some 65,000 product liability lawsuits have been consolidated in a West Virginia federal court. Covidien is also named as one of the defendants in the cases filed against Bard in the multidistrict litigation (MDL). Bard faces 9,234 cases in federal court and 200 claims against Bard are being prepared for trial in 2015; this does not include other lawsuits filed nationwide in state courts. Three federal cases were chosen as bellwethers. In one case, the plaintiff was awarded $2 million in actual and punitive damages, the second case was settled prior to trial, and the third case was dropped by the plaintiff before trial.
In a February 2014 filing, Covidien indicated that more than 5,600 lawsuits were pending over products that fall under Covidien jurisdiction and, in its third-quarter company report, indicated it is prepared for purchase by Medtronic, Inc.
Lawsuits similarly allege design and manufacturing defects, failure to warn, breach of warranty, fraud, violations of state consumer protection laws, and loss of consortium. Women also allege various injuries including, severe chronic pain, infections, mesh migration and erosion, and nerve damage, among other complaints.
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