Vaginal Mesh Products Still Under Fire
by Rob Jenner
on January 5, 2012
Common sense would require that a product that permanently goes inside the human body be tested on humans before being allowed to hit the road in the suitcases of medical device salespeople. That’s not what happened with vaginal surgical mesh. And women are paying the price.
Reports of injuries and deaths from vaginal mesh products used to treat urinary incontinence and pelvic prolapse have skyrocketed. Recently, the FDA ordered manufacturers to figure out why. Until researchers come up with answers, device makers should be held accountable and doctors need to level with their patients about vaginal mesh risks.
Last week the FDA ordered Johnson & Johnson and C.R. Bard Inc., two companies that make vaginal mesh products, to gather three years of data about organ damage, infection and painful sex linked to mesh implants.
The order comes six months after the FDA reported it had found a fivefold jump in deaths, injuries and malfunctions related to the products. That’s too long.
Vaginal Mesh Implant Can Lead to Severe Complications
According to the agency, almost 300,000 synthetic meshes were implanted in U.S. women in 2010 alone. So far, more than 650 lawsuits have been filed against manufacturers by women who suffered severe complications after getting the implants. One of the most common complications is that the mesh erodes the organs around it, causing pain, bleeding, bladder perforation, infection and even death.
On top of this, the FDA points out that no studies about the use of these mesh products have shown that mesh provided any benefit over older, more traditional treatments in many cases. An FDA advisory panel also has recommended that mesh products be labeled as “high risk,” which would require that they be tested in humans before being allowed on the market.
Bottom Line: Test, Then Market
So here we have a product that was never tested on humans, was marketed and distributed to gynecologists for use in treating hundreds of thousands of women, and has shown a huge rate of severe complications and death. And the government is calling for another study!
The studying ought to be done before the suffering and dying. Device makers should pull these products off the market until they have more data about how safe they are. Doctors, meanwhile, need to tell their patients about the risks involved in mesh products and the availability of safer alternatives.
What You Can Do If You’ve Been Harmed
If you are considering using a vaginal or pelvic mesh product, research the alternatives and talk to your medical professional about risks. If you underwent surgery and had mesh implanted, be sure to alert your doctor to any symptoms, such as pain and bleeding.
If you believe you have been harmed by a pelvic mesh product, call an experienced attorney who can walk you through your legal options.
Additional Transvaginal/Sling/Vaginal Mesh Product Resources:
Robert Jenner brings to the My Advocates medical and legal team more than 26 years experience representing injured consumers nation-wide against the manufacturers of dangerous prescription drugs, defective medical devices, tainted blood products, and other unsafe products. Mr. Jenner has been honored by his peers for inclusion in “The Best Lawyers in America” and “Maryland’s Super Lawyers”(named in Top 50). READ FULL BIO
