Vaginal Mesh Lawsuit Update – $5.5 Million Jury Awarded Verdict: This week’s news that a groundbreaking vaginal mesh lawsuit verdict had been reached in California came on the heels of a recent nationwide recall by Johnson & Johnson (J&J) of its Gynecare line of surgical mesh. A Kern County jury awarded $5.5 million in damages to a woman who suffered incontinence and chronic pain after being implanted with an Avaulta Plus vaginal mesh device, which was manufactured by C. R. Bard. Click here to learn more.
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.
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.
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
- 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.