What is the safety record of the Menaflex device?
The Menaflex has a strong, well-documented safety record. Members of the FDA Panel who recommended the Menaflex noted throughout their review that the risks associated with use of the device appeared to be low. The device has been used safely and effectively in more than 2,500 patients in Europe. From the multicenter clinical trial, the “explant” rate—i.e. the percentage of patients who had to have the device removed—was 4 percent, which is lower than most FDA-cleared surgical meshes. The rate of serious adverse events related to the device was 6.2 percent, also low in comparison with surgical meshes currently in use. The rate of serious adverse events among the patients who received the device was comparable to rates for patients who received a partial meniscectomy (the current standard of care for meniscus damage) without the device. Examples of serious adverse events include pain, swelling, stiffness, fever, infection, instability, and reduced mobility.
