Surgical mesh is a common medical product used to repair conditions in which body organs need extra support because the muscles and ligaments supporting internal organs weaken, causing the organs to sag inside the body cavity. Surgical mesh is used to create a kind of sling or hammock to keep the organs in their proper place. In women, it can be used to treat pelvic organ prolapse and stress urinary incontinence.
Unfortunately, this surgical solution is flawed. Over the past three years, the U.S. Food and Drug Administration (FDA) received nearly 4,000 reports of serious and severe complications associated with surgical mesh used to treat pelvic organ prolapse and SUI, including 3 fatalities. The most frequent complications include:
- Erosion through inner wall of the vagina;
- Mesh contraction, leading to vaginal shortening and pain;
- Urinary problems;
- Recurrence of prolapse and/or incontinence.
There were also reports of surgical complications when the insertion of the mesh perforated bowel, bladder, or blood vessels. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including painful sexual intercourse.
Now, according to an article in The New York Times, some of the dangerous products will no longer be available. Johnson & Johnson’s Ethicon division has decided to stop selling four types of mesh implants: Gynecare TVT Secur system, Gynecare Prosima, Gynecare Prolift, and Gynecare Prolift+M.
“This is very good news for women because it takes several products off the market that have harmed a lot of women,” said Diana Zuckerman, president of the National Research Center for Women and Families, a public health advocacy group. However, she said, “the bad news is that there are many other surgical meshes still on the market that are just as dangerous.”
And the products won’t be removed from market immediately, but phased out over the next three to nine months. That means more women will be put at risk before these brands of mesh are gone for good. And to add insult to injury, Johnson & Johnson is positioning this move to stop selling these brands of mesh as a response to “changing market dynamics,” not to safety or efficacy concerns. However, according to The New York Times:
In 2008, the Food and Drug Administration warned that use of the implants was associated with complications but that the problems were rare. But between 2008 and 2010, the agency reported a fivefold increase in reports related to the use of the devices. In January, the F.D.A. ordered makers of the implants to study their risks in patients.
Under the law, women who have been seriously injured by surgical mesh complications have the right to seek compensation for their losses and suffering from Johnson & Johnson, or any other company that manufactures the products.
If you or someone you care about has had surgery using transvaginal mesh to correct pelvic organ prolapse or urinary incontinence, you have the right to seek compensation for your losses and for your suffering. If you believe you have been seriously injured by transvaginal mesh, HensonFuerst Attorneys may be able to help. Someone is available 24 hours a day, 7 days a week to take your call, at 1-800-4-LAWMED; or contact us via our website at www.hensonfuerst.com.
Life Doesn’t Wait, and neither should you. If you have questions, HensonFuerst has answers.
To read the full article in The New York Times, click here: Johnson & Johnson Unit to Halt Urinary Implants
We also have a YouTube video about the dangers of transvaginal surgical mesh (although it was created before this latest move by J&J): Dangers of Transvaginal Surgical Mesh