Transvaginal Mesh Problems Reaching Epidemic Proportions
This is Michael Brady Lynch, lead trial attorney for The Michael Brady Lynch Firm.
Every week I am contacted by more and more women who are seeking help because of complications stemming from the implantation of a transvaginal mesh. Many of my clients are sadly unaware that problems with transvaginal mesh implants are not new and that the use of transvaginal mesh has a long and troubled history.
Although problems with transvaginal mesh implants have been well-known in the medical and legal communities for many years, public acknowledgment of the problems of transvaginal mesh first began in October 2008, those vaginal mesh complications when the FDA issued a health alert cautioning doctors about the risks associated with transvaginal mesh. At those vaginal mesh complications “rare.” The FDA advisory was followed by a rise in transvaginal mesh lawsuits due to increased public awareness of the health problems caused by vaginal mesh. After the FDA advisory, the FDA received over 2,800 reports of complications associated with transvaginal mesh procedures between 2008 and 2010. In July 2011, the FDA issued a specific warning regarding the high incidence of complications associated with transvaginal mesh when used for the treatment of pelvic organ prolapse (POP).
It is important to understand that the problems with transvaginal mesh implants are across the board and not limited to use for treatment of pelvic organ prolapse. Furthermore, the FDA has confirmed that transvaginal mesh complications are not limited to a single brand of vaginal mesh. In September 2011, an advisory panel recommended that transvaginal mesh be reclassified as high risk so that mesh manufacturers such as Boston Scientific and Ethicon, for example, would be forced to undergo rigorous testing in order to receive FDA approval. A partial list of manufacturers and products which have come under the scrutinity of the FDA include:
|American Medical Systems||Elevate, Apogee, Perigee|
|Boston Scientific||Pinnacle, Uphold|
|C.R. Bard, Inc.||Avaulta, Pelvisoft BioMesh, Pelvilace, Pelvitex, Pelivicol Acellular Collagen Matrix|
|Caldera Medical||Ascend Anterior, Ascend Posterior|
|Johnson & Johnson/Ethicon||Gynecare Prolift, Gynecare Prosima, Gynecare TVT, ObTape|
As part of its ongoing safety review, in January 2012 the FDA reached out to 35 vaginal mesh manufacturers and requested data on the safety and effectiveness of vaginal mesh implants. As expected, the cooperation from transvaginal mesh manufatcuers was less than enthusistsic. The FDA also mandated that manufacturers conduct safety studies on transvaginal surgical mesh implants, but these studies have been slow in coming and suffer from all the traditional drawbacks of self-critical analysis.
Trial lawyers like myself and a number of consumer watchdog groups have been very public in voicing the strong opinion that a transvaginal mesh recall is long overdue.
This is not to say that everyone that has a transvaginal mesh implant will suffer complications or be a candidate for a lawsuit. Although everyone implanted with a synthetic transvaginal mesh may have a theoretical legal claim, claims without specific damages are disfavored by courts and are typically not worth the expense and emotional burden of pursuing litigation. At The Michael Brady Lynch Firm, we carefully screen for cases in which the patient suffered either:
- Diagnosed organ damage due to adhesions to the bladder or urethra, or due to perforations of the bowel. Interstitial cystitis and fistulas are common terms used by physicians. Sometimes organ damage can be diagnosed if the patient had to be hospitalized after their mesh, tape or sling was implanted. Often, if organ damage has occurred, the patient’s treating doctor will recommend mesh removal, replacement or repair surgery, and sometimes tissue reconstruction surgery.
- Ongoing severe symptoms such as:
- the mesh eroding or sticking through the bladder, bowel or vagina,
- unexplained infection or recurring infections,
- pain during intercourse (“dyspareunia”)
- vaginal scarring, or erosion or sloughing of vaginal tissue,
- recurrence of vaginal prolapse, uterine prolapse, or,
- urinary problems like incontinence.
On the legal front, thousands of cases have been consolidated into the multidistrict litigation (MDL) in the U.S. District Court of West Virginia. The five companies involved are American Medical Systems, Boston Scientific Corp., Johnson & Johnson’s Ethicon, C.R. Bard and Coloplast. Trials of numerous cases are scheduled in both the MDL and various state jurisdictions throughout 2013.
Regardless of the manufacturer, the transvaginal mesh lawyers at The Michael Brady Lynch Firm are investigating potential claims for women who have received any type of surgical mesh or bladder sling to repair pelvic organ prolapse. If you or a loved one has suffered complications after implantation of a vaginal mesh product, please contact The Michael Brady Lynch Firm for a no-cost, confidential evaluation of your case.
About the Firm: The Michael Brady Lynch Firm is a trial firm with a focus on pharmaceutical mass tort cases involving SSRI and Anti-Seizure Medication Birth Defects such as Lexapro, Zoloft, Effexor, Prozac, Celexa, Paxil, Depakote and Topamax, as well as Pradaxa Internal Bleeding, Propecia sexual dysfunction, Actos Bladder Cancer and Fosamax Femur Fractures, and medical device cases including DePuy Hip and Transvaginal Mesh cases. Contact us today if you or someone you know has experienced side effects involving these products.