Medtronic, Inc has announced that they are going to increase its monitoring of the company’s medical devices after they are implanted in order to catch potential safety problems earlier.
Omar Ishrak, the CEO of Medtronic, Inc. states, ” it was the responsibility of companies to monitor devices for safety problems after they are approved rather than relying on irregular reports from doctors or patients, as they do now.” Ishrak believes that the FDA does not have the capability to adequately monitor every medical device in the market and so companies should shoulder some of the monitoring responsibility.
Medtronic is the world’s largest stand-alone medical device maker. Last year several research studies called into question the safety of their Infuse Bone Graft product, and serious concerns were raised about the way Medtronic Infuse side effects were reported in clinical trials for the bone graft. Some of these complications include:
- Difficulty breathing, swallowing
- Uncontrolled bone growth
- Nerve injury
- Male sterility
- Retrograde ejaculation
Reuters reported that consumer groups have urged the U.S. Food and Drug Administration to impose more rigorous testing of devices before they are approved to avoid safety failures, including issues with metal-on-metal hip implants and surgical mesh.