Transvaginal Mesh Manufacturers: Our law firm is currently accepting new transvaginal mesh claims against the following manufacturers: Johnson & Johnson, Bard, American Medical Systems or AMS, and Boston Scientific. See below “Products & Manufacturer List” for a list of the aforementioned manufacturers brand name transvaginal mesh products.
Why You Should Choose Schmidt & Clark, LLP
Our Experience – Defective Medical Device Litigation
“Our firm has significant experience in the area of defective medical devices and mesh related injuries.”
In addition to our national representation of numerous consumers injured by other forms of defective mesh products, our attorneys are actively involved in the investigation regarding the use of transvaginal mesh and vaginal mesh products.
We are able to draw upon the pool of experience gained in other mesh and products liability litigation to appropriately investigate, evaluate, and pursue potential transvaginal mesh injury claims.
What’s the Problem?
Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with vaginal mesh devices used to repair POP and SUI. These devices are usually placed transvaginally utilizing tools for minimally invasive placement.
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.
Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.
Specific characteristics of patients at increased risk for complications have not been determined. Contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.
FDA Video: Serious Complications with Surgical Mesh for Gynecologic Surgery
In February 2009, the U.S Food & Drug Administration released the video below, which warns of serious complications associated with the surgical mesh used to treat pelvic organ prolapse and stress urinary incontinence.
Transvaginal Mesh Complications
- erosion through vaginal epithelium
- pain, including dyspareunia
- urinary problems
- recurrence of prolapse and/or incontinence
- bowel, bladder, and blood vessel perforation
- vaginal scarring
- mesh erosion
Vaginal Mesh Recalls
To date, there has been a total of three recalls for vaginal mesh devices. Back in 1999, Boston Scientific pulled its ProteGen brand vaginal mesh off the market amid safety concerns. The ProteGen was a groundbreaking device due to the fact that it was not only the first surgical mesh designed exclusively for transvaginal applications, but it also paved the way for a huge number of other shoddy products to reach the U.S. market.
Within a year of the ProteGen gaining approval from the FDA, several other major manufacturers copied the design and released transvaginal mesh products of their own. Due to the similarities between these devices and the ProteGen, all of them were rushed to market via the FDA’s controversial 510(k) clearance loophole, which approves products without clinical testing. And while the ProteGen was recalled after three years on the market, the vaginal mesh devices created in its image have yet to be recalled.
Then in June 2012, Johnson & Johnson’s Ethicon division recalled the following brands of transvaginal mesh after more than 1,000 lawsuits had been filed against the manufacturer:
- Gynecare Prolift Kit
- Gynecare Prolift + M Kit
- Gynecare TVT Secure
- Gynecare Prosima Pelvic Floor Repair System Kit
A month after the J&J Gynecare recall, C.R. Bard stopped selling its Avaulta Plus line of vaginal mesh products after a California jury awarded a patient $5.5 million after being injured by one of the devices.
J&J to Pay $344 Million Over Transvaginal Mesh Marketing
Johnson & Johnson has been ordered to pay $344 million for misrepresenting the risks of transvaginal mesh implants to consumers in California, according to Bloomberg. The suit accused J&J and its Ethicon unit of “deceptively marketing their pelvic mesh products” for years without fully disclosing the risks of the devices, misleading users in violation of state consumer-protection laws. California is the first of the states that sued J&J to get its case to trial. Officials in Washington last year agreed to a $10 million settlement the day before the trial was to begin.
Pelvic Mesh Victim Awarded $41 Million in Philadelphia Lawsuit Against J&J Ethicon
Johnson & Johnson’s Ethicon unit has been slammed with a $41 million penalty in a lawsuit filed by a woman who claimed severe complications from the company’s pelvic mesh. The Philadelphia jury ruled that Ethicon’s Gynemesh, Prolift and TVT-O meshes were defectively designed, and that the company was negligent in manufacturing the devices, according to Law360.
Judge Affirms $13.7 Million Transvaginal Mesh Award
The Philadelphia judge presiding over a transvaginal mesh lawsuit that resulted in a $13.7 million judgment affirmed the award on appeal. The lawsuit was filed by Plaintiff Sharon Carlino, who alleged Ethicon’s mid-urethral sling failed because it was negligently designed, and that its failure caused her to suffer permanent pain during sex (dyspareunia).
Delaware Woman Awarded $100M in Transvaginal Mesh Lawsuit
A jury has ordered Boston Scientific to pay a record $100 million to a Delaware woman who was left permanently injured after being implanted with a transvaginal mesh sling. Newark resident Deborah Barba was awarded $25 million in compensatory and $75 million in punitive damages yesterday following a 2-week trial in Superior Court in Wilmington. The verdict is the largest ever against Boston Scientific over its transvaginal mesh products.
Ethicon Mesh Bellwether Trial Delayed
Product liability lawsuits involving vaginal mesh slings manufactured by Ethicon Inc. have been delayed, after the judge presiding over the multidistrict litigation (MDL) postponed the next pending bellwether trial until the new year. No reason was given for the delay, but the judge also issued a second order the same day requesting a joint status conference for all litigation involving transvaginal mesh products on Jan. 29, 2015.
Transvaginal Mesh Products & Manufacturer List
Johnson & Johnson
- Ethicon TVT
- Gynecare TVT
- Gynemesh PS
- Prolene Polypropylene Mesh Patch
- Avaulta Plus™ BioSynthetic Support System
- Avaulta Solo™ Synthetic Support System
- Faslata® Allograft
- Pelvicol® Tissue
- PelviSoft® Biomesh
- Pelvitex™ Polypropylene Mesh
American Medical Systems or AMS
- Advantage™ Sling System
- Obtryx® Curved Single
- Obtryx® Mesh Sling
- Prefyx Mid U™ Mesh Sling System
- Prefyx PPS™ System
Transvaginal Mesh Litigation
As of Jan. 2015, more than 60,000 transvaginal mesh lawsuits have been filed in state and federal courts throughout the U.S. Among them:
- Approximately 10,000 cases involving C.R. Bard;
- Approximately 18,000 cases involving American Medical Systems;
- Approximately 14,000 cases involving Boston Scientific;
- Approximately 22,000 cases involving Ethicon;
- Approximately 1,700 cases involving Coloplast;
- Approximately 300 cases involving Cook Medical, and
- Approximately 100 cases involving Neomedic.
To date, American Medical Systems is the only company to offer large-scale settlements. In 2014, Endo International Plc, owner of AMS, agreed to pay about $1.3 billion to resolve lawsuits. In most cases, these settlements involve women who have undergone 1 revision surgery or no revisions to repair injuries allegedly caused by the mesh. Women who have undergone 2 or more revision surgeries have not been included in the settlements.
Covidien Settles 11,000 Mesh Lawsuits
Medtronic’s Covidien unit has agreed to settle over 11,000 lawsuits related to its transvaginal mesh implants after a judge urged companies facing litigation to resolve cases with plaintiffs rather than taking them to trial, according to Reuters.
NEJM Study Finds Transvaginal Mesh Complication Risk High
A new study has confirmed prior research indicating that the use of vaginal mesh to treat pelvic organ prolapse carries the risk of serious complications including bladder perforation and pelvic hemorrhaging. These findings come just months after a number of doctors publicly expressed concerns about the risks associated with vaginal mesh surgery.
According to a study published in the New England Journal of Medicine (NEJM), transvaginal mesh devices are more effective at treating pelvic organ prolapse (POP) than conventional surgical procedures, but carry the risk of developing a number of extremely serious complications after surgery.
The study involved 389 women being treated for POP. 200 were implanted with vaginal mesh devices and 189 were treated with colporrhaphy, a more traditional form of vaginal wall repair that involves surgical intervention of a defect in the wall of the vagina. Of these, approximately 3.5% of women implanted with surgical mesh suffered from a bladder perforation during the surgery, compared to only about 0.5% of the women who received colporrhaphy. The rate of urinary incontinence was more than 12% for women who received a mesh device compared with only 6.3% for a colporrhaphy. The study also found that 3.2% of the women who received the mesh required revision surgery to correct problems with the device. According to the study’s authors, “As compared with anterior colporrhaphy, use of a standardized, trocar-guided mesh kit for cystocele repair resulted in higher short-term rates of successful treatment but also in higher rates of surgical complications and postoperative adverse events.”
These new findings confirm what many in the medical community have suspected for some time. In November 2010, a letter from Dr. Anne M. Weber of Pennsylvania published in the American Journal of Obstetrics & Gynecology suggested that there is a lack of specific scientific information on vaginal mesh health risks. Weber told the journal that the lack of information made it impossible for patients to give informed consent and suggested all vaginal mesh surgery be considered experimental.
Study Investigates Transvaginal Mesh Complications After POP Repair
According to the results of a study presented at the 28th annual European Association of Urology Congress, age and other risk factors seem to play a large part in contributing to a woman’s risk of developing complications following surgery for pelvic organ prolapse (POP). Younger women, those with less severe cases of POP, and those who underwent concomitant hysterectomies were more likely to develop complications than women without these risk factors. The new research comes as thousands of women around the country are filing transvaginal mesh lawsuits, alleging that the products are dangerous and inherently defective, and carry a risk of severe and debilitating health problems.
The new study, which was conducted by Russian scientists, involved a cohort of 677 test subjects treated at six different medical centers who underwent transvaginal mesh repair for POP from 2006 to 2010. Of the cohort, 152 women (17.3%) were found to have intra-operative, early postoperative and mesh-related complications. Specifically, transvaginal mesh complications included:
- Significant pelvic hematomas (5.5%)
- Vaginal hematomas (5.5%)
- Perineal hematomas (2.5%)
- Bleeding during surgery and losing over 500 cc of blood (2.2%)
- Bladder injury (1.6%)
- Rectal damage (0.7%)
There were also two cases of urethral injury and one case of urethral trauma reported in the test subjects.
Complications linked directly to transvaginal mesh placement for POP repair included:
- 32 incidents of mesh erosion (4.8%)
- Dyspareunia and pain (2.4%)
Additionally, the study participants reported a variety of other transvaginal mesh complications including:
- protrusion into the bladder
- mesh shrinkage
- pelvic abscess
- development of fistulas
Is the FDA’s 510(k) Approval Process a Giant Loophole?
Since 1976, all medical devices must be approved by the FDA before they can be legally marketed to the public. It is the fond belief that FDA approval is a ringing endorsement of a product’s safety, a guarantee that the device has been tested and re-tested by professionals. Unfortunately, this belief is far from accurate.
The FDA’s 510(K) approval process requires little safety information and only some information concerning the products’ efficacy. Once approved, the FDA may or may not require additional studies to be performed. Unfortunately, adverse event reporting for devices has never been very good. In fact, most medical devices currently on the market have not been tested rigorously enough to determine the potential for harmful or fatal events.
According to a recent report published in the British Medical Journal, running large scale clinical trials before the FDA approves everything is impractical, which makes the post-marketing monitoring even more important. Post-approval performance is especially vital for devices because they are less likely than drugs to be supported by clinical studies before being placed on the market. According to the report, these studies are not conducted or are “conducted so poorly as to be meaningless.”
Solutions to the Problem
The authors of the British Medical Journal study suggest that manufacturers be required to submit relevant data about their devices and provide a website where they can report when a device has been removed or deactivated. Another recommendation in the report is that the FDA should appoint an independent review board to determine whether adverse outcomes could be due to the product in question.
Bill Seeks to Close Controversial FDA 510(K) Loophole
House Democrats have overwhelmingly supported the notion that federal health regulators should have the authority to block medical devices that are based on past products with safety issues from entering the market. A bill introduced earlier this month would close the FDA’s 510(k) loophole that lets manufacturers win swift approval for devices like the much-beleaguered transvaginal mesh implants made by Johnson & Johnson and C.R. Bard Inc. The proposed legislation would require companies to explain why their products are different from recalled versions.
The controversy surrounding the FDA’s 510(k) approval process was sparked last year after the administration issued a public health alert for vaginal mesh implants, which had been reported to cause hundreds of women severe internal injuries. Vaginal mesh products were cleared for use on the U.S. market through 510(k), which lets technologies earn approval without human testing if the FDA determines them to be similar to other existing products. In October 2011, Bloomberg News published an article reporting that the approval of a number of mesh implants could be traced back to a Boston Scientific device that was recalled for safety issues in 1999.
“If an automobile is recalled for a major safety problem, we wouldn’t allow future models to repeat this same flaw, and the same should be true for the medical devices used in our bodies,” Massachusetts Rep. Edward Markey said in the statement. The bill would ensure “that devices do not mimic the mistakes made by other products.”
Current laws state that the FDA must approve a product for sale on the U.S. market if it is ‘substantially equivalent’ to a previously-approved device known as a predicate. The new legislation would allow the administration to deny the approval if the predicate device was recalled from the market, or if it was in the process of being recalled. The bill would also require the FDA to determine whether any have recalls in their ‘device lineage.’ A comprehensive report on these issues would be required to be submitted to Congress within 36 months of enacting the legislation.
Transvaginal mesh products were implanted in approximately 300,000 women a year to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Last month, the FDA ordered manufacturers of these devices to conduct more in-depth studies on the safety of their products.
- FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence
- New England Journal of Medicine (NEJM) Study on Transvaginal Mesh Complications: A new study published in the NEJM has confirmed that the use of surgical mesh to treat pelvic organ prolapse (POP) carries the risk of serious side effects including bladder perforation and pelvic hemorrhaging.
- Transvaginal Mesh FDA Warning: The FDA has issued an updated safety communication warning that surgical placement of transvaginal mesh to repair POP may expose patients to a greater risk of side effects than other treatment options. In addition to the increased risk of side effects, the FDA stated that vaginal mesh offers no greater clinical value or improved quality of life over other surgical methods.
- Public Citizen Calls on FDA to Recall Vaginal Mesh: In response to a high number of reports linking vaginal mesh products to erosion, pain, bleeding and urinary incontinence, the watchdog group Public Citizen has called on the FDA to recall the controversial devices.
Do I Have a Transvaginal Mesh Lawsuit?
The Medical Device & Products Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in transvaginal mesh and vaginal mesh lawsuits. We are handling individual litigation nationwide and currently accepting new transvaginal mesh complication cases in all 50 states.
If you or a loved one have been injured or suspect that you may have complications directly linked to the placement of a transvaginal mesh or vaginal mesh implant, you should contact us immediately. You may be entitled to compensation for your injuries and we can help.