If you had a transvaginal mesh (TVM) implant, also known as a pelvic mesh implant or bladder sling, and are suffering from painful, serious side effects after one or more revision surgeries, you are not alone. Complications involving transvaginal mesh devices have been reported in tens of thousands of women in relation to nine different transvaginal mesh manufacturers, including Boston Scientific, C.R. Bard, Inc., Covidien and Johnson & Johnson subsidiary Ethicon, Inc.
FDA ORDERS CEASE OF ALL SALES OF TVM/PELVIC MESH PRODUCTS
April 16, 2019
Declaring that it “has not received sufficient evidence to assure that the probable benefits of [TVM] devices outweigh their probable risks,” the U.S. Food and Drug Administration announced today that it has ordered all manufacturers of surgical transvaginal mesh repair products to halt all sales of the devices in the U.S.
The FDA concluded that the devices “do not have reasonable assurance of safety and effectiveness,” giving manufacturers 10 days to submit plans on how they intend to withdraw the products from the market. Read the FDA’s full statement. Read the FDA’s full statement.
Transvaginal Mesh Side Effects
Pelvic mesh devices are surgically implanted for the correction of pelvic organ prolapse (POP) or stress urinary incontinence (SUI). Many injuries and side effects have been associated with defective pelvic mesh products.
In particular, severe health complications have required one or more surgeries to repair or remove mesh.
Contact medical attorneys Fidelma Fitzpatrick or Jonathan Orent by email or call 1.800.768.4026 to learn if you may have a case related to side effects from a pelvic mesh, transvaginal mesh or bladder sling implant.
Our Leadership Roles in Pelvic Mesh Lawsuits
Motley Rice co-founder Joe Rice negotiated, with co-counsel, the original AMS settlement that subsequent settlements with the manufacturer have been modeled from. Medical attorneys Fidelma Fitzpatrick and Jonathan Orent serve as co-liaison counsel in the In re Bard Litigation in New Jersey state court, as well as state court liaison counsel in Massachusetts. Fidelma also serves as co-lead counsel in In re American Medical Systems, Inc. Pelvic Repair Systems Product Liability Litigation and as state court liaison counsel in Delaware. Medical attorney Fred Thompson serves as co-lead coordinating counsel for the pelvic mesh lawsuits consolidated in the U.S. District Court for the Southern District of West Virginia and as a liaison in the Bard Avaulta multidistrict litigation in West Virginia federal court.
Transvaginal Mesh Lawsuits Background
While surgical mesh has been used since the 1950s to repair abdominal hernias, gynecologists began using surgical mesh to treat POP and SUI in the 1990s. The first surgical mesh specifically designed for SUI was approved by the FDA in 1996. In 2002, it approved the first surgical mesh specifically for use in POP. Between 2005 and 2010, nearly 4,000 injuries were reported to the FDA in connection with transvaginal/pelvic mesh devices.
In January 2016, the FDA announced the reclassification of transvaginal mesh used to surgically repair POP from a moderate-risk device to a high-risk device. In its announcement, the FDA stated it was giving all manufacturers of current mesh on the market 30 months to submit proof that their devices are safe and effective as proven by clinical trials. For new POP mesh, the FDA now requires the manufacturer to submit a premarket approval application with data demonstrating the effectiveness and safety of the devices before it receives FDA approval and is released to the medical market. The FDA later determined in April 2019, however, that the manufacturers failed to meet premarket standards by providing sufficient evidence that showed the safety and efficacy of the devices. As a result, the agency ordered that all manufacturers cease sales of TVM devices. Read more.
In April 2014, Motley Rice co-founding member Joe Rice announced that an Agreement in Principle had been reached with TVM manufacturer American Medical Systems and parent company Endo International Plc on behalf of approximately 6,000 women who used AMS’s transvaginal mesh device. Read more.
In February 2013, a New Jersey jury awarded $3.5 million in compensatory damages to the plaintiffs in a transvaginal mesh lawsuit against Johnson & Johnson due to alleged problems with its Ethicon Gynecare Prolift device. Read more.
In June 2012, Chief Judge Joseph Goodwin and Magistrate Judge Mary Stanley (U.S. District Court for the Southern District of West Virginia) were notified by letter that Ethicon was voluntarily recalling four Pelvic Floor Repair Systems. Read the full notification letter.
In September 2011, the FDA issued a recall of certain transvaginal mesh devices. An FDA advisory panel also met to discuss the safety of medical drugs and devices, including transvaginal mesh, and recommended tougher premarket testing of vaginal mesh products and the reclassification of the devices to a Class III—the highest-risk category for medical devices—without recalling existing products.
The FDA warned patients and healthcare providers in July 2011 of the risks associated with the use of transvaginal mesh and recommended they consider alternatives for treating POP and SUI; conditions that may occur after childbirth and pregnancy. Manufacturer market data from 2010 indicates that approximately 100,000 women underwent surgery using mesh to repair POP while more than 200,000 SUI surgeries were performed transvaginally with mesh.
In October 2008, the FDA issued a public health notification alerting healthcare providers and the public about the increasing number of serious health issues associated with transvaginal mesh.
Motley Rice LLC, a South Carolina Limited Liability Company, is engaged in the New Jersey practice of law through Motley Rice New Jersey LLC. Esther Berezofsky is the attorney responsible for New Jersey practice.