Johnson & Johnson continued to sell vaginal mesh implants for nine months after federal safety regulators told the company to stop marketing the device. According to a Bloomberg report, the U.S. Food and Drug Administration (FDA), which had received numerous consumer complaints about adverse effects, told the health-care products maker in a letter dated August 24, 2007 to stop selling Gynecare Prolift until the agency decided if the device was “substantially equivalent” to other products on the market. In its letter, FDA officials cited the potentially high risk for organ perforation when surgeons insert the mesh vaginally to shore up weakened pelvic tissues.
The letter prohibited J & J from marketing the device until they provided adequate information and got FDA approval. Selling the device would be a violation of federal law, the letter stated. The FDA cleared the device in May 2008. But, in the interim, J & J continued to market and sell the products.
Life-Changing Side Effects
Now, the company faces more than 1,400 vaginal mesh lawsuits from women who allege a variety of painful side effects including organ perforation, pain, scarring and even nerve damage. Nearly 300,000 in the United States were implanted with these mesh devices in 2010. J & J had started selling Prolift in 2005 without filing a new application after determining on its own that the device was substantially similar to Gynemesh, which was already cleared by FDA. However, FDA officials disagreed with J & J’s interpretation and required that the company file a new application.
Lack of Studies and Testing
This information comes to light even as the U.S. Senate is looking at making changes to the FDA’s device review system, which allows medical devices to be sold without human testing if there are other “substantially similar” products already in the market. Transvaginal mesh implants are among several medical devices that have found their way into the market and into people’s bodies without safety studies or testing. In January, the FDA ordered J&J, Murray Hill, New Jersey-based C.R. Bard Inc. and other manufacturers to study organ damage and complications related to these defective products. The agency received 123 complaints about Prolift from 2005 to May 15, 2008, when the device was cleared.
Justice for Victims
It is absolutely outrageous that this industry giant thought that it could get away with violating federal law. Thanks to the lawsuits that have been filed by thousands of women, these facts are now coming to light. The FDA letter was recently unsealed in court at the request of plaintiffs’ attorneys. This also seriously questions the FDA’s ability to enforce the law. One expert quoted in the Bloomberg news report compares the FDA to “a sheriff packing a water pistol.”
These mesh implant products have left thousands of women all over the country with life-changing and irreversible side effects. This account highlights yet another instance of how the safety and health of consumers are compromised by reckless manufacturers who are unwilling to put consumer safety above profits. If you have been affected by these defective products are looking for more information about pursuing your legal rights, please click here.