Sales of Four Pelvic Mesh Products Being Dropped Following More than 600 Lawsuits by Injured Women
By Dean I Weitzman, Esq. on June 12th, 2012
When you go into a hospital for surgery, you expect to go home in better condition than when you arrived.
Sadly, that’s not always the case because sometimes the very products that are supposed to help you in surgery can end up harming you.
That’s apparently the case with pelvic mesh products that are used to treat medical problems in women, according to a story by The Associated Press (AP).
In some cases, surgical mesh products that were surgically implanted in women to treat a condition known as pelvic organ prolapse – when the cervix, uterus, bladder or other reproductive organs slip down into the vagina due to the weakening of pelvic muscles – caused higher rates of pain, bleeding and infection than surgery involving traditional stitches, according to a U.S. Food and Drug Administration (FDA) report, the AP story stated.
Now consumer goods manufacturer Johnson & Johnson (J&J) said it will stop selling four types of surgical mesh implant products over the next nine months, AP reported. The mesh products “have been linked to injuries and triggered hundreds of lawsuits,” the story said.
J&J said the products are safe and that it isn’t recalling the products, but is just ceasing sales of them, according to the AP. About 75,000 women had this kind of surgery last year, according to the story.
Thirty to fifty percent of women may experience pelvic organ prolapse (POP) in their lifetimes, with two percent developing symptoms, the FDA reported.
Last July, however, the FDA issued a “safety communication” that reiterated warnings about “serious complications associated with surgical mesh placed through the vagina” to treat the problem. The FDA “identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern.”
The FDA alert also updated an earlier FDA advisory which was issued back in 2008, the agency said. The complications from surgical mesh being used to treat POP “are not rare,” the FDA stated (emphasis added by the FDA).
In a list of recommendations for health care providers, the FDA suggests that they obtain “specialized training for each mesh placement technique, and be aware of the risks of surgical mesh.” The agency also recommends that doctors are “vigilant for potential adverse events from the mesh, especially erosion and infection, as well as “for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.”
Another key, the FDA recommends, is that doctors should “recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications.”
The FDA also recommends that patients who suffer adverse effects from the use of the surgical mesh promptly report their case to the agency through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
”There are clear risks associated with the transvaginal placement of mesh to treat POP,” Dr. William Maisel, deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health, said in a statement last year. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications.”
In 2010, there were at least 100,000 POP repairs that used surgical mesh, according to the FDA. About 75,000 of these were transvaginal procedures.
J&J is being sued by more than 600 women in connection with internal injuries they say were caused by the pelvic mesh, according to a story in BusinessWeek. “The FDA in March said New Brunswick, New Jersey-based J&J had sold one of the implants, the Gynecare Prolift, for three years without proper regulatory approval,” BusinessWeek reported. “That followed the agency’s order in January that J&J and 30 other makers of vaginal mesh implants study organ damage and other health complications blamed on the products, which are used to treat incontinence and shore up weakened pelvic muscles.”
Lawsuits have also been filed against other makers of pelvic mesh products, including C.R. Bard Inc. of Murray Hill, N.J., and Endo Health Solutions Inc. of Chadds Ford, Pa., BusinessWeek reports.
The FDA has received “more than 1,500 reports of complications related to the mesh from 2008 to 2010, including cases where the it eroded into the vagina or caused bleeding and infection,” according to a story by Reuters. “The rate of problems was five times the rate reported from 2005 to 2007.”
The controversy and health implications involving surgical pelvic mesh are real and are still evolving, but patients who have been affected and seriously injured can protect their rights by consulting an experienced, compassionate and expert personal injury attorney to learn about the legal options that exist for them.
We here at MyPhillyLawyer have deep experience with medical malpractice cases and can help you obtain the monetary damages that you are entitled to as compensation for your injuries and pain and suffering.
When Winning Matters Most, call MyPhillyLawyer.