Product liability lawsuits alleging that vaginal mesh devices implanted in women are defective and that manufacturers failed to warn about their dangers are shaping up into a widespread mass tort against makers Johnson & Johnson, C.R. Bard and others.
Did you experience mesh erosion or other mesh complications following pelvic organ prolapse surgery? Find out if you can seek compensation for your injuries by contacting our office with details of your mesh complications.
The Food and Drug Administration wrote J&J , C.R. Bard and 31 other manufacturers, telling them to conduct three years of trials on safety and effectiveness of the mesh implants, the agency’s William Maisel said in an October telephone interview. An FDA report in July found a fivefold jump in deaths, injuries or malfunctions tied to the products.
Almost 300,000 synthetic meshes were implanted in U.S. women in 2010 to treat incontinence or shore up pelvic muscles, the agency estimates. The devices’ alleged failures have spurred more than 650 lawsuits against manufacturers and heightened scrutiny of the FDA program that cleared the products for sale without human testing.
An advisory panel recommended the FDA reclassify mesh used for pelvic organ prolapse, a condition in which weakened muscles fail to support internal organs, as “high-risk” devices that require human testing. The FDA hasn’t made a decision yet, Maisel said. The agency isn’t likely to heed the call of some patient advocates for a complete recall, he added.
Currently, there are already hundreds of cases around the country and plaintiffs’ lawyers say the number of calls they are receiving has picked up dramatically since the Food and Drug Administration issued an alert questioning the products’ safety and efficacy.
In one case, plaintiff and her husband allege that after the wife received the APOGEE synthetic mesh implant in June 2006, she was unable to sit, lie down or walk for extended periods of time, and required two additional surgeries that left her with “gross deformities” of the vagina and inability to control her bowel functions, perform household tasks or stay employed. The couple seeks compensatory and punitive damages against the manufacturer, American Medical Systems Inc.
The lawsuits allege that the mesh products, made of the plastic polypropylene or bovine material, are incompatible with placement in a woman’s pelvic area and result in various complications, including eroding, migrating, adhering or poking through various organs.
The Mesh is a Problem: What You Can Do
The estimated number of vaginal mesh implants in women across the country is in the hundreds of thousands. Women complain that the implants cause substantial pain, that they can’t stand up or sit down, can’t have sex and a nasty brown discharge comes out of places it should not.
Other complaints are that the products, both polypropylene and those made of bovine material, are incompatible with the pH and bacterial environment in the vagina, causing a vicious cycle of infection and inflammation.
A California woman in a bellweather case set for trial in February alleges that she underwent nine surgeries to try to remove a C.R. Bard vaginal mesh product, according to her attorney.
Plaintiffs’ spouses also have loss of consortium claims based on “debilitating pain during intercourse, making marital relations difficult if not impossible.”
Another criticism is that evidently the vaginal mesh is inserted in a blind procedure, where doctors cannot see where they are anchoring the device.
For patient safety, the FDA and the manufacturers should have done clinical trials to test this product.
Potentially individuals may be able to seek compensation for medical bills, pain and suffering and other damages resulting from their mesh problems. There is a time limit for filing vaginal mesh lawsuits, so do not hesitate to contact us today.
Call 856-845-0011 and ask to speak with Attorney Jon Ivans or Attorney Jeffrey Puff.