Medical Device Manufacturer Medtronic Recall of Devices in 2011
Medical device manufacturer Medtronic had to recall many devices in 2011.
The following is a list of Medtronic items recalled in 2011:
- Kappa pacemakers
- Sigma pacemakers
- MiniMed Paradigm insulin pumps
- SynchroMed EL implantable pain medication pump
- SynchroMed II implantable pain medication pump
There are also recalls on some of their products that are not implanted via surgery. Infuse bone growth stimulant is their latest product in question. Infuse is a bone morphogenic protein-2, or BMP-2 that was approved by the FDA in 2002 for use in spinal lumbar fusion surgery. The FDA later gave approval for Infuse in a couple of types of dental surgery. Many doctors have used Infuse in off-label use, meaning they utilized it in a manner outside of the FDA approved uses. The FDA issued a statement in 2008 against off-label use of Infuse. The news for Medtronic and Infuse only gets worse.
In November 2011, Medtronic paid a Yale researcher and cardiologist to conduct “an unbiased third party” appraisal of patient data related to Infuse use. Lawsuits are mounting due to complications being blamed on the use of Infuse. These complications are:
- Inflammatory reactions (allergic reactions to the protein resulting in pain, swelling)
- Unintended/uncontrolled bone growth
- Radiating leg pain
The Yale research is being done as damage control for research done by at least 13 Orthopedic surgeons who submitted reports to Spine Journal that grossly under reported the rates of complications with Infuse use. These surgeons were also generously compensated for their “research” to the tune of many millions of dollars apiece. A Senate committee is currently investigating the journal reports and payments made to “researchers” of Infuse. The same Senate committee is also investigating five other medical device producers. A congressional committee is investigating Medtronic’s marketing practices. The US Department of Justice is investigating the off-label use of Infuse. Also, a class-action law suit status has been approved for shareholders of Infuse that have lost money due to poor everything associated with Infuse. One can only hope the patients Infuse was used on and their families also gain justice from this debacle.