CHARLESTON, W. Va--(BUSINESS WIRE)--Johnson and Johnson (JNJ), and its subsidiary, Ethicon, Inc., are going on trial this week in the US District Court for the Southern District of West Virginia, facing charges that one of its pelvic mesh devices, the TVT-O, was defective and that the company was negligent and fraudulent in its representation of the product.
We Are Mesh Survivors, a coalition of women hurt by pelvic mesh and their supporters, will provide coverage of this landmark trial from the courtroom in Charleston, West Virginia. Jane Akre, National News Editor of Mesh News Desk, will be sitting in on the proceedings and providing daily reports at MeshMedicalDeviceNewsDesk.com.
To coincide with the start of the trial, We Are Mesh Survivors is releasing a report by the Corporate Action Network entitled, Putting Women at Risk, The Case Against Pelvic Mesh. “The report documents Johnson & Johnson’s irresponsible actions from the very first time it brought mesh devices to the marketplace in the late 1990s by skirting the already insufficient regulatory approval process to today’s court proceedings,” said Mark Fleischman, Executive Director of the Corporate Action Network, the corporate accountability group that produced the report. “The report also covers the company’s refusal to respond to increasing evidence of the devices’ dangers to the women who received them.”
The We Are Mesh Survivors coalition will also meet with members of Congress this week to ask them to support Congressional efforts to investigate the regulation, oversight, and marketing process of pelvic mesh. This mobilization follows last month’s mass submission of comments on an FDA proposal to reclassify pelvic mesh for the treatment of pelvic organ prolapse (POP) as a class-III, ‘high-risk’ device. Mesh survivors submitted hundreds of comments and the proposal is awaiting a final decision.
Pelvic mesh is a medical device originally designed for hernia repair that was repurposed for use in women suffering from conditions including pelvic organ prolapse (POP) and stress urinary incontinence (SUI). However, the device was never tested by the US Food and Drug Administration (FDA) for this use. Nonetheless, some of the world's largest medical device manufacturers, led by J&J, have sold millions of these devices to be implanted in women throughout the country.
Nearly 100,000 individual lawsuits have been filed against mesh manufacturers in the United States as a result of these injuries. In its most recent quarterly report, Johnson & Johnson admits that it alone faces 33,000 pending lawsuits over its pelvic mesh devices.
“This trial is critically important to women and their families from across the US who have needlessly suffered from injuries related to pelvic mesh implants,” stated Akre. “The largest manufacturers of these devices have known for years about these potentially serious complications. However, they have continued to manufacture, market, sell – and most importantly – profit from these products.”
“We will be closely monitoring this case and will document testimony provided by the plaintiffs, J&J, and any medical experts with involvement,” Akre continued. “The more the general public is made aware of this case and the complications related to mesh, the better informed – and better protected – consumers will be in the future. Women and their physicians should be fully informed of all the potential issues before any decision is made for using pelvic mesh implants.”
We Are Mesh Survivors is a coalition of synthetic vaginal mesh implant survivors and survivor groups that have united to demand justice for those who have suffered and to demand that existing products be pulled from the market until their safety can be demonstrated. Mesh survivors have been hurt by defective, dangerous products pushed to market by corporations looking to make as much money as quickly as possible with little regard for safety. Together, We Are Mesh Survivors will make sure the world knows what has been done to them and stop it from happening to others.