Ethicon Makes Allegedly Dangerous Transvaginal and Hernia Mesh
Johnson & Johnson’s Ethicon division makes a number of transvaginal mesh devices, which are used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Women who are implanted with these products are told that they will get relief for their conditions, but many say that the mesh only made their lives worse.
One of the most common complaints, for instance, regards mesh erosion; this is when the mesh moves and cuts through the vaginal and pelvic tissues, causing immense pain. Surgery is performed to remove the mesh, but in some cases, scar tissue has already formed around the mesh, making it extremely difficult to remove. Some women needed multiple surgeries and still have not found relief.
In addition to vaginal mesh lawsuits, the mesh lawyers at Parker Waichman are also offering free legal consultations to individuals who suffered injuries associated with the use of Ethicon’s Physiomesh, used for laparoscopic (minimally invasive) ventral hernia repair.
Johnson & Johnson’s Ethicon Unit Stops Selling Four Transvaginal Mesh Devices
On June 4, 2012, it was revealed that Johnson & Johnson’s Ethicon division would stop 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 it had asked the U.S. Food and Drug Administration (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 Johnson & Johnson
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.
Thousands of cases have been filed in the U.S. District Court for the Southern District of West Virginia over transvaginal mesh implants. So far, there are five multidistrict litigations (MDLs) pending in that court against Ethicon/Johnson & Johnson, Boston Scientific, C.R. Bard, American Medical Systems, and Coloplast over their pelvic mesh implants. Alleged injuries in these lawsuits similarly include:
- Additional surgery and multiple revision surgeries
- Emotional distress
- Loss of ability to have sexual relations spousal loss of consortium
- Loss of quality of life
- Lost wages
- Out-of-pocket medical, surgical and hospital expenses
- Pain and suffering
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.
Safety Issues with Transvaginal Mesh
Transvaginal mesh is approved to treat POP and SUI. In 2008, the FDA released a Safety Communication warning that complications 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 compared to non-mesh methods. In fact, using transvaginal mesh for POP may actually pose greater risks, the alert stated.
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
- Painful sexual intercourse
- 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
An expert advisory group convened by the FDA in September 2011 also expressed some concerns about the safety of transvaginal mesh.
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 (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. Many 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.
A majority of the Obstetrics and Gynecology Medical Device advisory panel agreed that the safety, effectiveness, and benefits of transvaginal mesh devices in POP repair are not well established and needs to be followed up in the long term. The agency proposed reclassification of mesh devices that were used for POP repair to Class 3 from Class 2. This meant that surgical mesh designed for POP repair could no longer be approved via the FDA’s lax 510(k) route, and manufacturers would need to conduct clinical tests to prove that their devices are safe and effective. This also meant that transvaginal mesh manufactured by Johnson & Johnson and other companies had not been clinically tested before being sold and implanted in thousands of women.
In January 2016, the FDA announced that transvaginal mesh would be reclassified as Class 3, meaning the devices must go through the stricter premarket approval, and submit clinical data to show safety and efficacy. The order only applies to transvaginal mesh devices marketed for POP repair, and not for SUI or other uses. “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, according to the FDA announcement. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued post-market surveillance measures.”
Ethicon Recalls Physiomesh, Used for Hernias, Due to High Reoperation Rates
The recall of the Ethicon Physiomesh was issued because, compared to other mesh devices used for hernia repair, data showed that patients implemented with the Physiomesh Flexible Composite Mesh experienced higher rates of recurrence/reoperation. Ethicon informed healthcare providers of the issue in a May 25, 2016 “Urgent Field Safety Notice”.
Unpublished data from two large independent hernia registries, one in Denmark and the other in Germany, showed that the Ethicon Physiomesh Flexible Composite Mesh had higher recurrence/reoperation rates compared to the average rates of comparator mesh devices.
Ethicon could not pinpoint a specific cause for the higher rates of reoperation with the Physiomesh, attributing the finding to several different factors. “Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors.” the letter states. “Consequently, Ethicon [has] not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and [has] decided to recall Ethicon Physiomesh composite mesh from the global market,”
“Ethicon will not return the Ethicon Physiomesh composite mesh product to the market worldwide.” the company indicated.
Parker Waichman mesh attorneys note that the Physiomesh contains polypropylene in its base layer, the same material used in transvaginal mesh implants.
Legal Help for Women Suffering from Ethicon Transvaginal Mesh Complications
Our firm is representing numerous women in lawsuits over transvaginal and hernia mesh implants, including Ethicon transvaginal mesh and hernia mesh products. To find out more about pursuing a lawsuit or to get free legal advice from one of our attorneys, please fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529) today.
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