Transvaginal Mesh Recall
Many of the thousands of women who have suffered serious injuries and complications from procedures intended to correct pelvic organ prolapse or stress urinary incontinence are exploring their legal options and seeking information about whether a large-scale transvaginal mesh recall has been issued.
Widespread reports of severe harm stemming from mesh implants have resulted in the filing of thousands of lawsuits across the country, and the sheer volume of adverse event reports associated with such products has caught the attention of the media and regulators alike.
The product liability lawyers of The Sanders Firm understand the devastating nature of the damage transvaginal mesh devices have caused countless women, and we are committed to pursuing justice and fair compensation for the victims we represent.
History of transvaginal mesh complications
Upon their introduction to the market in the late 90s, transvaginal mesh devices were touted as a low-risk method of achieving relief from stress urinary incontinence and pelvic organ prolapse, conditions often developing in the aftermath of childbirth. However, within a few short years, thousands of women began to suffer serious, often life-altering complications, now believed to be linked to the mesh devices.
Some of the most common vaginal mesh injuries reported include:
- Dangerous infections
- Mesh erosion through to the vaginal tissue
- Severe bleeding
- Perforation of the organs
- Pain during intercourse
- Ongoing urinary problems
Many women injured as a result of their vaginal mesh implants were forced to undergo risky, painful revision surgeries requiring extended recovery periods and expense. It should come as no surprise that many victims of transvaginal mesh side effects and complications have since decided to seek compensation through the courts.
Attorneys at The Sanders Firm believe that every woman who has been injured by a defective medical device should have the opportunity to pursue justice, and we have built a lengthy track record of securing substantial settlements and verdicts for our clients.
Manufacturer-initiated transvaginal mesh recalls
Though complaints and lawsuits alleging serious harm stemming from transvaginal mesh products have been mounting for years, the U.S. Food and Drug Administration has yet to issue any sort of large-scale recall of the devices. However, several manufacturers have initiated recalls of their own on certain products and others have simply stopped selling others, once questions about their safety began to emerge.
Noteworthy transvaginal mesh recalls and market withdrawals include:
- Boston Scientific’s decision to recall its ProtoGen mesh implant in 1999
- A 2012 decision by Johnson & Johnson’s Ethicon subsidiary to stop selling four distinct Gynecare mesh products and to update labeling on products slated to remain on the market
- C.R. Bard’s 2012 decision to cease production of the Avaulta Plus implant, first approved in 2008
- Mentor Corporation’s decision to replace its ObTape sling with a new product in 2006
These voluntary recalls and market adjustments were the direct result of the large number of allegations, adverse events and consumer concerns over the safety of mesh devices, and they lend support to plaintiffs who believe that defective design, testing and a lack of proper warnings caused them to suffer life-changing, possibly permanent harm.
At The Sanders Firm, our mission is not simply to obtain maximum compensation for our clients, but also to hold negligent device manufacturers accountable for the danger to which they subjected the public at large.
FDA and watchdog groups sound alarm bells
While it is true that the FDA has yet to issue a far-reaching recall pertaining to transvaginal mesh products that is not to say that the agency has not sounded the alarm about serious concerns about their safety. In 2008, the FDA issued a Public Health Notification discussing serious complications linked to surgical mesh. In 2011, that FDA communication was updated to reflect the agency’s position that potentially dangerous complications stemming from mesh implantation were not rare and that the health benefits to patients of receiving the mesh may not outweigh the risk.
The FDA recommended that:
- Healthcare providers be vigilant in watching for adverse events after implantation
- Doctors inform patients of the permanent nature of the surgery and the risk of mesh complications
- Healthcare providers choose mesh implantation only after a thorough balancing of the risks and benefits
- Patients seek additional information from their doctor before agreeing to a mesh implantation procedure
In August of 2011, consumer watchdog group Public Citizen called for a universal recall of all mesh products constructed of non-absorbable synthetic material used to repair pelvic organ prolapse. The group asserted that the FDA has a duty to remove such products from the market because they do not offer substantial benefits to patients, but rather pose the risk of devastating, permanent damage.
Current status of TVM litigation
Transvaginal mesh lawsuits continue to be filed at a rapid rate, with well over 50,000 already underway. In order to consolidate the litigation and create efficiencies in the discovery process for cases with similar fact patterns, seven multidistrict litigations (MDLs) have been established in the U.S. District Court for the Southern District of West Virginia in order to handle cases filed in federal court.
Lawsuits continue to be filed throughout the country in both state and federal courts, with no signs of slowing. In 2012, a California jury awarded $5.5 million to a plaintiff who suffered injuries caused by the Avaulta Plus device manufactured by C.R. Bard. March of 2013 saw an $11 million award in the first Ethicon mesh lawsuit to a patient who was harmed by implantation of a Gynecare Prolift device. C.R. Bard also lost the initial federal Avaulta mesh trial and was required to pay the plaintiff $2 million in compensation.
The Sanders Firm has represented the victims of defective medical devices for over 45 years and have the resources, experience and sophistication necessary for success.
Product liability lawyers you can count on
At The Sanders Firm, we understand the feelings of anger and mistrust that can result when a medical device causes serious harm. We also know that product liability cases of this type are often extremely complex matters that require a high level of sophistication and technical expertise. Throughout their careers, our attorneys have worked to establish and maintain an unrivaled network of medical experts, researchers, case investigators and support staff, all of whom play an important role in the service we provide. These resources, combined with our commitment to giving each client the personalized, compassionate attention they deserve, are what set us apart from our competitors.
If you have questions about a transvaginal mesh recall or have suffered harm as a result of an implantation procedure, you owe it to yourself and your family members to explore all of your legal options for filing a personal injury lawsuit. For a no-obligation, confidential consultation, contact us day or night at 1-888-743-1031.
- Public Citizen, Surgical Mesh in Pelvic Repair Procedures Should Be Recalled, Public Citizen Tells FDA, http://www.citizen.org/pressroom/pressroomdirect.cfm?ID=3405
- U.S. Food and Drug Administration, FDA Safety Communication: UDPATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm
- NJ.com, Jury says Johnson & Johnson must pay $1.2M over defective vaginal-mesh implant, http://www.nj.com/business/index.ssf/2014/04/post_285.html