New York, New York (PRWEB) March 09, 2012
Parker Waichman LLP, a national law firm representing plaintiffs in medical device lawsuits, announces that it has filed three federal complaints on behalf of women allegedly injured as a result of transvaginal mesh products. The lawsuits include a complaint filed in the U.S. District Court, Eastern District of Tennessee on behalf of a woman from that state allegedly injured by tranasvaginal mesh devices manufactured by American Medical Systems, including the Perigee System with IntePro Lite, the Apogee System with IntePro Lite, and MiniArc Sling (Case No. 3:12-cv-00067). A lawsuit filed in the U.S. District Court, Northern District of Georgia, Gainesville Division, alleges that a Plaintiff from Georgia sustained serious injuries as result of Boston Scientific Corp.'s Obtryx Transobturator Mid-Uretheral Sling System (Case No. 2:12-cv-00034-RWS). A third complaint filed on behalf of an Arizona woman in the U.S. District Court, District of Arizona, alleges the Plaintiff sustained injuries as a result of the Gynecare Prolift device marketed by Ethcion, Inc., a division of Johnson & Johnson (Case No. 2:12-cv-00274-MEA).
According to the complaints, all of the women named in the lawsuits were implanted with transvaginal mesh products during surgical procedures to treat pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI). All three lawsuits allege that because of having the devices implanted in their bodies, each experienced significant mental and physical pain and suffering, has sustained permanent injury, permanent and substantial physical deformity, and loss of bodily organ system, and has undergone or will undergo corrective surgery or surgeries.
The manufacturers of the transvaginal mesh devices named in the complaints all sought U.S. approval for the products via the Food & Drug Administration's (FDA) 510(k) clearance protocols, which do not require a formal review of the safety and efficacy of a medical device if it is deemed “substantially equivalent” to other predicate devices marketed prior to May 28, 1976, according to the lawsuits.
All three complaints allege that, because of numerous defects, the named transvaginal mesh devices create an unreasonable risk of injury and other adverse health consequences for patients, including, but not necessarily limited to, vaginal erosion, infection, extrusion, perforation, chronic pain and/or abscess. Among other allegations, all the lawsuits claim that the named Defendants were on notice of numerous bodily injuries caused by the products, and based thereon, knew or should have known that the devices caused an unreasonably high rate of vaginal erosion, infection, extrusion, perforation, chronic pain and/or abscess in women implanted with them.
"The injuries suffered by these three plaintiffs are typical of the kinds of complaints we're hearing every day from women who have received transvaginal mesh implants during surgeries to repair POP and SUI," said Gary P. Falkowitz, a lawyer with Parker Waichman LLP. "These complications are life-changing, and in many instances, the victims of transvaginal mesh injuries will never be able to recover their previous quality of life."
About Transvaginal Mesh Products
In October 2008, the FDA announced that it had began a review of transvaginal mesh products, after receiving more than 1,000 reports of complications related to the use of the devices in the surgical repair of POP and SUI. In July 2011, the FDA announced that it had received an additional 1,503 reports of transvaginal mesh complications associated with POP repairs and an additional 1,371 reports associated with SUI repairs. The most common side effects reported to the FDA included erosion through the vaginal tissue, pain, infection, bleeding, pain during intercourse, organ perforation during placement, and urinary problems. The FDA also emphasized that POP transvaginal mesh complications are not rare, a change from the position it took in 2008. fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm]
On September 8 and 9, 2011, the FDA's Obstetrics and Gynecology Devices Advisory Panel met to discuss the safety of transvaginal mesh devices in POP repair. Though no formal vote was taken, the majority of outside medical experts on the panel backed the FDA's proposal to reclassify transvaginal mesh devices as high risk, which would make such devices ineligible for the agency's 510(k) protocols. In January 2012, the FDA directed the makers of transvaginal mesh products, including American Medical Systems, Boston Scientific and Johnson & Johnson, to conduct post-market safety studies of their products in order to enable the agency to better understand the safety and effectiveness profiles of these devices. [fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm]
Parker Waichman LLP continues to offer free lawsuit consultations to victims of transvaginal mesh injuries. If you or a loved one experienced complications following POP and SUI surgery with transvaginal mesh, please visit the firm's transvaginal mesh injury page at yourlawyer.com.
Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
For more information regarding transvaginal mesh lawsuits and Parker Waichman LLP, please visit: yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Contact: Parker Waichman LLP