Transvaginal mesh (also known as vaginal mesh) products have been linked to over 1,000 reported serious, life-threatening side effects or adverse events within the last three years.
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.
Update: Pelvic Mesh Victim Awarded $41 Million in Philadelphia Lawsuit Against J&J Ethicon
February 1, 2019 – 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.
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.
Free Transvaginal Mesh Lawsuit Review: 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 product, you should contact us immediately. You may be entitled to compensation for your injuries and we can help.
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.
Read the Full Transcript: Serious Complications with Surgical Mesh for Gynecologic Surgery
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.
Judge Affirms $13.7 Million Transvaginal Mesh Award
January 11, 2017 – 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
May 29, 2015 – 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. Click here to learn more.
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. Click here to learn more.
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 Lawsuit Update
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. Settlements notwithstanding, Covidien still faces legal battles over its transvaginal mesh products. Two of the company’s subsidiaries supplied mesh to another device maker, and Covidien is compensating that manufacturer in some cases, it said in a regulatory filing. However, the company that received the mesh products should also pay Covidien in some cases for marketing the products, it added. Click here to learn more.
- 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 Complicatiions: 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. Click here to read more.
- 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. Click here to learn more.
- 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. Click here to read more.
Do I Have a Transvaginal Mesh Lawsuit or Vaginal 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 product, you should contact us immediately. You may be entitled to compensation for your injuries and we can help.