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 now many say that the mesh only made their lives worse.
One of the most common complaints regards mesh erosion; this is when the mesh moves and cuts through the vaginal and pelvic tissues, it causes immense pain. Surgery is then performed to remove the mesh, but in some cases, scar tissue has already formed around the mesh. This makes it extremely difficult to remove. Some women needed multiple surgeries and still have not found relief.
In addition to vaginal mesh lawsuits, the top 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. We can help you decide whether you have good grounds for a Ethicon mesh lawsuit.
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 still 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 Transvaginal Mesh Case Against Johnson & Johnson
In February 2013, Johnson & Johnson and Ethicon lost the first of some 4,000 Gynecare Prolift cases that went to trial. After the Ethicon mesh 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 Johnson & Johnson.
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 not only Ethicon/Johnson & Johnson, but also manufacturers Boston Scientific, C.R. Bard, American Medical Systems, and Coloplast over their pelvic mesh implants. Alleged injuries in these pelvic mesh lawsuit actions 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
Ethicon Mesh Lawsuit Update: J&J to Settle Vaginal Mesh Lawsuits for $120 Million
In January 2016, Johnson &Johnson agreed to settle a large number of transvaginal mesh lawsuits through a series Ethicon mesh settlements. 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. However, the Johnson & Johnson Ethicon mesh settlement resolves only 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 individually or through an Ethicon mesh class action 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. Several Ethicon mesh lawsuit settlements are likely to ensue. Ethicon mesh settlements in 2019 were awarded and other cases continue to settle to this day.
Safety Issues with Transvaginal Mesh
Transvaginal mesh was approved to treat POP and SUI. In 2008, the FDA released a safety warning that complications with pelvic mesh were rare, but serious. In 2011, the FDA pivoted and released an update on this announcement, indicating that complications associated with transvaginal mesh were “not rare.” Additionally, the FDA cautioned that transvaginal mesh does not appear to have clear benefits for POP repair when compared with non-mesh methods. In fact, using transvaginal mesh for POP may actually pose greater risks, the alert warned.
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 uncovered at an Ethicon mesh trial 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 Section 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.
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 III, 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 III from Class II. This meant that surgical mesh designed for POP repair could no longer be approved via the FDA’s easier 510(k) route and that manufacturers would now need to conduct clinical tests to prove that their devices are safe and effective. This also confirmed that transvaginal mesh manufactured by Johnson & Johnson and other companies had not been clinically tested to FDA the stricter standards before being sold and implanted in thousands of women.
In January 2016, the FDA announced that transvaginal mesh would be reclassified as Class III, meaning the devices would now be required to go through the stricter FDA standards for premarket approval, and submit clinical data to show safety and efficacy.
Ethicon Recalls Physiomesh
The recall of Ethicon Physiomesh was issued because, compared to other mesh devices used for hernia repair, data showed that patients implemented with Physiomesh Flexible Composite Mesh experienced higher rates of recurrence/reoperation. Ethicon informed healthcare providers of the issue on May 25, 2016.
Unpublished data from two large independent hernia registries, one in Denmark and the other in Germany, showed that Ethicon Physiomesh Flexible Composite Mesh had higher recurrence/reoperation rates compared to the average rates of comparative mesh devices.
Ethicon could not pinpoint a specific cause for the higher rates of reoperation with Physiomesh, but instead attributed the finding to several different factors. Parker Waichman mesh attorneys note that Physiomesh contains polypropylene in its base layer, the same material used in transvaginal mesh implants and a possible cause of the high rates of reoperation.
Legal Help for Those Suffering for 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 learn more about pursuing an Ethicon mesh 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.