By Lisa Merolla for Body1
The Food and Drug Administration is reconsidering the safety of Menaflex, a collagen implant used for meniscus
repair, after finding its approval process was tainted by outside political pressure.
On September 24, the FDA said Menaflex had been cleared for use despite being rejected twice by scientific reviewers. The device, manufactured by the New Jersey-based ReGen Biologics Inc., was approved in December 2008.
Four New Jersey Congressmen played a key role in pushing the approval through, the FDA said. The lawmakers – Senators Robert Menendez and Frank L. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman – had lobbied then-FDA commissioner for its clearance after receiving political donations from ReGen.
Handling a Meniscus Injury:
Symptoms of a meniscus injury include pain and swelling of the knee. Patients sometimes report a “popping” of the knee, or the sensation of it “giving way.”
The first step for most knee injuries is RICE: rest, ice, compression and elevation. Drugs like ibuprofen and aspirin can help as well.
If you suspect a meniscus injury, call your doctor immediately to discuss your best treatment option.
For a persistent meniscus injury, your doctor may recommend arthroscopy surgery to repair the tear. Other surgical options include meniscal transplantation or scaffolding.
If you are interested in following the availability of the Menaflex device, you can track it here.
The FDA said this “constitutes a clear deviation from the principles of integrity” in their report analyzing the Menaflex review process. According to the report, the FDA should reevaluate Menaflex’s safety and take steps to protect future scientific recommendations from political lobbying. This is the first time the FDA has publicly questioned one of its approval procedures.
So far, 30 patients in the United States have received the Menaflex device, as well as nearly 3,000 in Europe. Doctors surgically implant the C-shaped pad into the knee to repair injuries to a patient’s medial meniscus, the rubbery cartilage that cushions the knee. Menaflex, which costs approximately $3,000, is supposed to serve as a scaffold to guide new tissue growth.
ReGen countered the FDA report, saying that Menaflex is safe for use. The company said the FDA focused its review on the agency’s internal approval procedure, not the safety of Menaflex. “ReGen stands behind Menaflex and believes that the scientific evidence for its collagen scaffold is solid,” Gerald E. Bisbee Jr., the chairman and chief executive officer of the company, said in a press release.
The company pointed to a July 2008 study published in The Journal of Bone and Joint Surgery that followed 75 patients who had received a collagen meniscus implant. The study concluded that the implants helped to safely replace lost meniscus tissue in patients with a chronic injury. Some of the study’s researchers were funded by grants from ReGen.
In a conference call with reporters, Joshua Sharfstein, the FDA’s principal deputy commissioner, told patients who have already received Menaflex not to panic. They should wait for the FDA to review the device before making any decisions.