Johnson & Johnson’s Ethicon division recently announced it will not continue to market four vaginal mesh implants that have been the subject of lawsuits for having caused serious internal injuries. In response, Congressman Edward J. Markey (D-Mass.), praised the corporation’s wise choice.
“Johnson & Johnson’s decision to stop marketing the mesh implant that caused massive internal injuries to thousands of women is a welcome announcement,” writes Markey, senior member of the Energy and Commerce Committee.1
The June 4 letter from Ethicon to the FDA names four meshes: Gynecare TVT Secur™ System, Gynecare Prosima™ Pelvic Floor Repair System, Gynecare Prolift™ Pelvic Floor Repair System, and Gynecare Prolift+M™ Pelvic Floor Repair System.2
Concerning Ethicon’s letter, Matthew Johnson, a J&J spokesman, is quoted in a Bloomberg report: “The move wasn’t a recall and J&J remains confident in the safety and effectiveness of the devices. The company won’t withdraw the Prolift before its ‘planned discontinuation’ of the mesh products over the next 3 to 9 months.”3
Johnson wrote: “J&J began selling 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.”3
A more profound problem
Congressman Markey stresses that there is a deeper problem: a loophole in the FDA approval process for medical devices. Under the current 510(k) process, a device does not need to undergo clinical testing in humans before being sold. Instead, the FDA clears the device based on its similarity to a product already on the market, known as a “predicate.” Once a device has been cleared by showing that it is substantially equivalent to another product, it can become a predicate for future devices. The problem arises when a predicate has been removed from the market because its use places patients at risk.1
“The FDA approves more than two dozen medical devices per year based on a previous product that has since been recalled even though these devices are five times more likely to be recalled themselves,” reports Markey.
Legislation to help the FDA reject a device
In February, Markey, with Henry A. Waxman (D-Calif), Jan Schakowsky (D-Ill.), and Rosa DeLauro (D-Conn.), introduced H.R. 3847, the Safety Of Untested and New Devices Act of 2012 (SOUND Devices Act). This bill will allow the FDA to reject a device if it is based on an earlier product that has been recalled for causing serious harm to patients.
“This legislation fixes a glaring loophole in that regulatory framework. It gives FDA authority to deny clearance if the predicate on which the clearance is based was voluntarily recalled because it was unsafe due to an intrinsic flaw in its design or technology,” writes Rep. Waxman.4
We want to hear from you! Tell us what you think.