It appears J & J sold the vaginal mesh to unsuspecting doctors and victims even after they were ordered tp stop. So many women call us daily with so much pain and agony. These poor women were victims of a manudfacturer whi apparently put profits over people. There is nothing a fine or slap on the wrist can do to bring a womend life back to normal. We are reaching out to you. If you have not added your name to the vaginal mesh lawsuits you must now. We must obtain justice. See article below
J&J Sold Vaginal Mesh Implant After Sales Halt Ordered
By David Voreacos and Alex Nussbaum on June 26, 2012
Johnson & Johnson (JNJ) (JNJ), the biggest health-care products maker, continued to sell a vaginal mesh implant for nine months after U.S. regulators told the company to stop marketing the device, according to court records.
The U.S. Food and Drug Administration told J&J in a letter on Aug. 24, 2007, to halt Gynecare Prolift sales until the agency decided whether the device was “substantially equivalent” to other products on the market. The FDA cited the “potential high risk for organ perforation” when surgeons insert the mesh vaginally to support weakened pelvic tissue.
“You may not market this device until you have provided adequate information” on 16 potential deficiencies and received FDA approval, the agency told New Brunswick, New Jersey-based J&J in the letter. “If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug and Cosmetic Act.”
The FDA cleared the device in May 2008 without ordering sanctions, after nine months of negotiations with J&J’s Ethicon unit. The company faces more than 1,400 lawsuits by women who say the mesh caused organ perforation, pain, scarring and nerve damage. Lawyers for the women say the device’s approval history could increase J&J’s cost to resolve the litigation.
“If a company knows the FDA tells them, ‘Don’t sell a device,’ they’re supposed to not sell it,” Adam Slater, an attorney suing on behalf of 150 women, said in a phone interview. “It’s egregious that J&J was selling the device without clearance.”
The 2007 letter was part of a group of documents filed under seal in state court in Atlantic City, New Jersey, and made public in May at the request of Slater, a partner at Mazie Slater Katz & Freeman LLC in Roseland, New Jersey. Lawsuits also are pending in federal court in Charleston, West Virginia.
J&J began selling (JNJ) the Prolift in 2005 without filing a new application after determining on its own that it was substantially similar to the Gynemesh, a company device already approved by the FDA, said Matthew Johnson, a J&J spokesman, in an e-mail. The device maker relied on FDA guidance for when companies must submit new applications, Johnson said.
The FDA disagreed with J&J’s interpretation and required a new application that prompted questions in the August 2007 letter, Morgan Liscinsky, an agency spokeswoman, said in an e-mail.
J&J faced no sanctions because the FDA determined that the company applied the guidance in good faith and it “promptly complied” when the agency required a new application, Liscinsky said.
Sanctions for selling products without approval may include fines, injunctions against a company or senior managers and the seizure of illegally marketed devices, Liscinsky said.
The August 2007 letter was “only one part of an extended dialogue with FDA in 2007-08, and it is out of context,” Johnson said in the e-mail. “Throughout this process, our actions were responsible, appropriate and consistent with FDA regulations.”
Henry G. Garrard III, a lawyer who represents women suing in federal court in Charleston, said the FDA’s failure to take additional steps to halt Prolift sales or to sanction J&J raises questions about the agency’s power to protect patients.
“Companies know the FDA has little enforcement ability and scarce resources,” Garrard, of Blasingame, Burch, Garrard & Ashley PC in Athens, Georgia, said in a phone interview.
“Every woman in America who has been implanted with these devices absolutely should be outraged,” he said. “They should be mad at the company because the company knew they could get away with it.”
Surgeons thread mesh implants through vaginal incisions and use the devices to treat incontinence or pelvic organ prolapse, a condition in which weakened muscles fail to support organs. Almost 300,000 were used in U.S. women in 2010, the FDA estimated last year.
An FDA database of reported malfunctions, deaths and serious injuries shows the agency received 123 complaints about the Prolift from 2005 to May 15, 2008, when the device won clearance. The company said in a September 2007 letter to regulators that reported problems accounted for less than 0.5 percent of sales for both Gynemesh and Prolift.
An agency report in July found a fivefold jump in deaths, injuries or malfunctions tied to prolapse mesh inserted vaginally. In January, the FDA ordered J&J, Murray Hill, New Jersey-based C.R. Bard Inc. (BCR) (BCR) and other manufacturers to study organ damage and complications related to the products.
J & J has just removed the Gynacare of the market for four of the devices and changed the labeling for a fifth. They claim this not to be a recall and for financial reasons only. The vaginal mesh helpline can only say “how very interesting indeed”.
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