I support the advisory panel’s recommendation to reclassify the transvaginal mesh surgical products. Hopefully, their decision will help to protect the countless number of women who have suffered from transvaginal mesh complications ...
Dallas, Texas (PRWEB) September 16, 2011
On September 8th, 2011 an advisory panel announced it backed the U.S. Food & Drug Administration's (FDA) decision to call for more clinical studies and the reclassification of transvaginal mesh to the highest-risk, Class III medical device products. The Schmidt Firm, LLP, a law firm actively handling transvaginal mesh lawsuits throughout the country supports the panel’s findings.
Michael E. Schmidt, Managing Partner of The Schmidt Firm, LLP has noticed an alarming number of inquiries to the firm related to transvaginal mesh complications. Mr. Schmidt stated, “I support the advisory panel’s recommendation to reclassify the transvaginal mesh surgical products. Hopefully, their decision will help to protect the countless number of women who have suffered from transvaginal mesh complications after undergoing surgery for pelvic organ prolapse.”
After reviewing clinical research, listening to patient testimony, and hearing the opinions of FDA officials, the Obstetrics and Gynecology Devices Panel determined to back FDA recommendations of increased regulation and study of mesh products inserted transvaginally in pelvic organ prolapse (POP) repair. While there was not a formal vote, the majority of panelists showed their support of the regulation change.
The new regulations would reclassify transvaginal mesh as a Class III product.
Currently, transvaginal mesh products used for POP repairs are labeled Class II products, regulated under the 510(k) process. Under this approval process, new products need only demonstrate they are “substantially equivalent” to existing products on the market. The devices are cleared after only in vitro bench and animal testings — meaning, they can be cleared without undergoing clinical studies on people.
Without sufficient clinical study, the Class II label puts POP patients at serious risk of complications including erosion, pain, dyspareunia, infection, urinary problems, bleeding, organ perforation, recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage and emotional problems. Some of these complications can require multiple corrective surgeries.
Class III is the highest-risk category of medical devices and mandates premarket approval study, including obligatory clinical trials on people in well-designed studies to prove a product’s safety and effectiveness.
For products already on the market —they should undergo postmarket study, the advisory panel said.
In a July 13, 2011 Safety Communication, the FDA announced it had received 1,503 reports of complications associated with transvaginal mesh POP repairs, on top of an additional 1,000 prior to 2008. The FDA warned the complications were not rare and transvaginal mesh procedures showed no benefit over other traditional non-mesh POP repairs. Transvaginal mesh procedures introduce patients to risks not present in traditional non-mesh surgeries, the FDA said.
Based upon their own findings, the FDA made a recommendation prior to the committee’s meeting that POP transvaginal mesh products be reclassified as highest-risk and undergo further study to solidify safety and effectiveness. To ensure the safety of patients, the September 8th advisory panel agreed and is backing FDA plans for premarket and postmarket study.
In 2010, the FDA said, there were at least 100,000 POP repairs that used surgical mesh. 75,000 of these were transvaginal mesh procedures.
Mesh products in POP repair are made by several manufacturers including Johnson & Johnson, C.R. Bard and Boston Scientific Corp.
To date, over 500 lawsuits have been filed against two manufacturers of POP transvaginal mesh, Johnson & Johnson and C.R. Bard, according to a recent Bloomberg article.
The Schmidt Firm, LLP has been recognized as one of the nation’s leading plaintiff’s law firms and represents individuals nationwide who have been injured by transvaginal mesh.
To learn more about transvaginal mesh complications or your legal rights in filing a transvaginal mesh lawsuit, the law firm suggests that you visit their website: http://www.schmidtlaw.com/transvaginal-mesh or call them toll free by dialing (866) 920-0753.