Virginia Beach, VA Medical Malpractice Lawyer Report: Lawsuits Multiply over Vaginal Mesh

By John Cooper, Virginia Beach Defective Products Attorney

The vast number of lawsuits currently being brought over injuries caused by vaginal mesh products, raises new questions over a fast track approval process a which allows products to go onto the market with minimal testing.

Litigation moved forward on Jan. 26, 2012 when Derek H. Potts, a medical malpractice attorney, appeared at a hearing in Miami, FL that may plot the course of many transvaginal surgical mesh lawsuits being brought across the USA.

The hearing concerned motions that Potts and other lawyers filed in November, 2011 with the U.S. Judicial Panel on Multidistrict Litigation (JPML) representing women who say they suffered injuries after being implanted with vaginal mesh which is used for the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP).

The plaintiffs are asking the panel to create separate multidistrict litigation cases against three different manufacturers of mesh: American Medical Systems, Inc., Boston Scientific Corp. and Ethicon, Inc.

See this video about transvaginal mesh.

They say coordinating the actions will lead to more consistency. They are also asking that cases be transferred to the U.S. District Court for the Southern District of West Virginia.

As a Viginia Beach, VA medical malpractice attorney, I’m appalled at the scale of this apparent safety lapse in the regulatory system.
In October 2008, the U.S. Food and Drug Administration issued a notice about transvaginal surgical mesh.

“Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement,” the FDA said in a statement.

“The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.”

Ominously an update was issued in July, 2011 in which the FDA said “serious complications associated with surgical mesh,” are “not rare.”

But should the FDA share some of the blame? These vaginal mesh products were approved through the FDA’s controversial 510(k) fast-track approval process; the only requirement is that a product should be substantially equivalent to a device that has already been approved for sale. This approval process was also used for DePuy hip transplants – another device that had led to intense suffering for patients and many lawsuits.

Yet the 510 (k) regulator process is more than 35 years old and has come under fire for years. Surely it’s time to look again at a system that makes patients guinea pigs due to the lack of testing.

Recently the FDA sent out a letter to product makers calling for the new post-marketing studies on transvaginal mesh. This seems somewhat late in the day, although I would welcome it if eventually heralds the beginning of tighter regulations.
The mesh is used to treat pelvic organ prolapse, a common medical condition which occurs when organs drop and push against the walls of the vagina. Childbirth and surgery can cause the condition.

It’s a fairly common procedure. In 2010 alone, there were at least 100,000 surgeries that used surgical mesh implants.
Alarmingly the FDA is now saying the risk of using mesh implants is greater than other surgical options and there is no evidence of a greater clinical benefit.
This raises the fundamental and worrying question as to why these devices ever went on the market in the first place.
DM

The Norfolk and Virginia Beach based personal injury law firm, Cooper Hurley, handles car, truck, and motorcycle injuries as well as brain injury, wrongful death, railroad workers’ injuries (FELA) mesothelioma and medical malpractice. John Cooper and Jim Hurley have over 40 years of combined experience in handling auto injury accident claims. Attorney John Cooper has been named to Virginia “Super Lawyers” since 2010 and has been a member since 2011 of the Multimillion-dollar Advocates Roundtable. Cooper Hurley represents people hurt in accidents in Norfolk, Virginia Beach, Portsmouth, Suffolk, Chesapeake, Hampton, Newport News and throughout VA, and always put the best interests of the our clients first. The firm is recognized by other lawyers as “AV” by Martindale-Hubbell, a national attorney rating service, for our top level of legal skill and highest ethical standards. If you need help or advice about a serious injury, please call us (757) 455 -0077. For a free consultation with a specialized Hampton Roads, Virginia personal injury lawyer contact us through this website