Transvaginal Mesh Attorneys
04/03/2014 – A Texas jury has ordered Johnson & Johnson (J&J) to pay $1.2 million in compensatory damages to a woman who alleged one of the company’s vaginal-mesh implants was defectively designed. Lawyers argued that the TVT-O mesh sling implanted in Linda Batiste caused pelvic pain as the device eroded. This is reported to be the first verdict against J&J involving these devices.
Johnson & Johnson Discontinues Sales of Vaginal Mesh Implants
Johnson & Johnson’s Ethicon plans to stop sales of four vaginal mesh implant products worldwide due to the large number of women suing them for mesh-related health complications. More than 600 women have come forth claiming the implants have caused organ damage, malfunctions, and other injuries known to result in death.
Back in January, the Food and Drug Administration (FDA) ordered J&J, along with 30 other vaginal mesh implant manufacturers, to study internal injuries linked to these products, which were expected to remedy incontinence and hold up weakened pelvic muscles. In March, the FDA determined that J&J, based in New Brunswick, New Jersey, had sold the Gynecare Prolift implant for three years without proper consent.
The Gynecare Prolift was introduced by Ethicon in March 2005 as an “innovative and effective surgical option” for women with prolapse issues. The FDA found out about the Prolift in 2007 after J&J tried to obtain approval for a related product. The FDA disagreed with the company’s statement that it could advertise the Prolift with no approval because of its close similarity to the approved Gynecare Gynemesh.
Matthew Johnson, a company spokesman, clearly stated that the company’s decision to discontinue these mesh implants is not derived from safety concerns, but rather from factors such as the “availability of other treatment options for women.” They expect all sales to cease within the first few months of 2013. Ethicon has asked the FDA for permission to continue selling a fifth product, Gynecare Gynemesh, with revisions to the product’s labeling and solely for abdominal implantations.
The attorneys at Robinson Calcagnie Robinson, Inc. are representing women who have suffered injuries or complications related to the use of transvaginal mesh and pelvic sling implants. If you or someone you love has been injured as the result of a vaginal mesh or pelvic sling implant, please contact us immediately for a free and confidential case evaluation.
Transvaginal Mesh MDL Judge Joseph Goodwin Appoints Karen Barth Menzies to Plaintiffs’ Steering Committee (PSC)
On April 13, 2012, Judge Joseph Goodwin, appointed the attorneys who will represent transvaginal mesh and pelvic sling implant product liability cases filed in federal courts throughout the country. The cases have been consolidated in a multidistrict litigation (MDL). An MDL is a process that consolidates similar cases before a single judge in order to make the litigation process more efficient by avoiding the duplication of evidence gathering and preventing inconsistent rulings.
Karen Barth Menzies of Robinson Calcagnie, Inc., was among a select group attorneys appointed to the Plaintiffs’ Steering Committee (PSC) who will oversee the entire litigation process and guide the plaintiffs’ side of the litigation.
If you or a loved one received a vaginal mesh or pelvic sling implant and have suffered an injury or side effect related to the implant, please contact us for a free and confidential evaluation of your case.
FDA Issues a Warning Concerning Transvaginal Mesh Products
For many women suffering from pelvic organ prolapse (POP), a condition in which the bladder, uterus, rectum or vagina slip out of place, or stress urinary incontinence (SUI), the implantation of a transvaginal mesh device was assumed to be a welcome relief to treat their condition. Instead, the implantation of the faulty devices left many women experiencing life-altering side effects and devastating complications.
In October of 2008, the FDA released a warning discussing the potential complications that can arise from the use of mesh repair products used to treat POP and SUI. Today, the use of these transvaginal mesh products to repair POP or to treat SUI is controversial, as other safer, more effective surgical methods are available.
Complications associated with the use of transvaginal mesh products are well documented and include:
- erosion through the vaginal epithelium
- permanent nerve damage
- scarring of vaginal tissue
- pelvic pain and discomfort
- urinary problems
- pain during sex
- recurrence of the prolapse and/or incontinence
- bowel, bladder, and blood vessel perforation during the surgical procedure
Women who are affected by these side effects may need additional surgery to remove the vaginal mesh product, and as a result of such complications, many women report chronic discomfort and a reduced quality of life.
Further Action by the FDA Indicates the Lack of Efficacy and Safety of the Transvaginal Mesh Products
In July 2011, due to numerous reports of injury by women who have used the transvaginal mesh products, the FDA took the unusual step of updating its warning regarding the use of the products, reiterating to doctors and patients that the use of the mesh repair systems can put patients at a greater risk of mesh complications than patients who select other surgical options.
In September 2011, the FDA held public hearings regarding the transvaginal mesh products. As a result, the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee of the FDA made several recommendations. Notably, in regards to mesh products for POP repair, the Committee concluded: (1) the safety of the products in POP repair has not been well-established (2) the products may not be more effective than traditional repair methods (3) the risk-benefits of transvaginal mesh devices are not well-established and (4) that studies are necessary to evaluate the use of surgical mesh for POP repair. As for transvaginal mesh products, the Advisory Committee suggested that the devices be reclassified, requiring the disclosure of more patient information such as labeling and informed consent, mandatory registration of mesh devices used in procedures, as well as heightened surgical training, education, and credentialing.
Lawsuits Filed: Contact Robinson Calcagnie, Inc. for a Free Review of Your Potential Legal Claim
The side effects of the transvaginal mesh products can seriously decrease the quality of life. As a result, a number of lawsuits have been filed against the manufacturers of the products including: Johnson & Johnson/Ethicon, Inc.; American Medical Systems; Boston Scientific; C.R. Bard; Coloplast; Caldera Medical; and others, as it is possible that these manufacturers designed a defective mesh product and failed to warn doctors and patients of the potential side effects.
If you have experienced any of the side effects associated with transvaginal mesh products, you may be entitled to compensation for your medical bills and pain and suffering. Do not hesitate to contact our attorneys at Robinson Calcagnie, Inc. for a free consultation to determine whether you are eligible to participate in a lawsuit against the makers of these defective mesh products.