Transvaginal Mesh Makers in Deeper Trouble

August 17, 2012, 10:30AM. By Jane Mundy

Dallas, TXHow do women with transvaginal mesh implants react when they discover that the faulty medical device was cleared by the FDA without ordering sanctions? It must be especially egregious to those women who had a vaginal mesh implant made by Ethicon, a subsidiary of Johnson & Johnson.

“I am just so angry about getting implanted with this transvaginal mesh,” says victim and patient advocate Lana Keeton. “I am an educated woman and I am aware of the issues surrounding TVM, but I believe they are being kept under wraps because of the huge liability—for doctors, hospitals and insurers.”

And the transvaginal mesh manufacturers.

The largest healthcare company was told by the FDA (8/24/07) to stop selling its Gynecare Prolift until the agency decided whether the device was "substantially equivalent" to other products on the market. The FDA’s doubts were clear: the device had a "potential high risk for organ perforation". Despite the letter telling J&J it will be in violation of the Federal Food, Drug and Cosmetic Act, the company went ahead and sold its transvaginal mesh for the next nine months.

Re. Edward Markey introduced a bill in February that would allow the FDA to reject faulty vaginal mesh, but he did not get enough support to adopt this amendment to the Senate Bill. The Sound Devices Act was introduced because of complications caused by vaginal implants products and hip replacements. (It will be tried again when the bill moves to the Senate floor).

Markey introduced legislation to close the loophole in the flawed 510 (k) process, which allows a new device to be marketed based on its similarity to an earlier product—even if that earlier product was pulled from the market for causing serious harm to patients.

According to Markey’s website, the SOUND Devices Act:

• Provides FDA the ability to reject a device application based on a predicate that has been recalled or is in the process of being removed from the market for major safety problems;
• Requires companies to inform FDA if any products in their new device’s “predicate lineage” have caused serious harm and to explain how theirs avoids past mistakes;
• Instructs FDA to maintain a publicly accessibly database that companies can use to determine whether a device can be used as a predicate;
• Strengthens reporting requirements so that companies and the public can easily determine why a recall occurred (information that is often missing in the case of voluntary recalls);
• Calls for FDA to review the safety of high-risk devices if a product in their “predicate lineage” is recalled due to major safety problems.

Johnson & Johnson Lawsuit

Meanwhile, at the end of July 2012, Atlantic County Superior Court judge Carol Higbee ordered J&J’s new CEO, Alex Gorsky, to provide a videotaped deposition regarding the upcoming Ethicon transvaginal mesh lawsuits pending before a New Jersey Superior Court, where more than 1,000 transvaginal mesh cases have been filed. As well, extensive electronic searches of executives’ computers have been ordered.

(It won’t be Gorsky’s first time he has testified in court. In January 2009 he testified in a court case alleging that J&J marketed its drug Risperdal for off-label uses. The Department of Justice fined J&J $1.1 billion after it determined the company hid the dangers of the drug and marketed it illegally.)

“We look forward to questioning the most senior J & J executives in order to find out what was known at the highest levels, and to gain an understanding for why these pelvic mesh products have been marketed to patients and physicians despite the company’s knowledge of serious safety problems from the outset,” said attorney Adam Slater, who filed the first New Jersey case in 2008, claiming these products are defective.

Ethicon still markets vaginal mesh products as “safe, effective and reliable”, despite thousands of reports from women who have suffered irreversible and life-threatening injuries from its products.