Complications Spur FDA Probe of Medtronic Marketing Practices

It’s proponents call it a miracle medical device that promotes bone growth while helping patients avoid the pain of bone grafts. Detractors cite the 280 complaints to the FDA concerning side effects with Medtronic’s Infuse Bone Graft, some of which have been life threatening.
Once again, the focus is one the marketing practices of Medtronic. Critics have pointed out that doctors have the ability to employ drugs as well as medical devices for uses that are considered off-label. However, medical device manufacturers and pharmaceutical companies do not have a right to market their products for such off-label uses. Herein lies the controversy with Medtronic’s Infuse Bone Graft. Critics are accusing Medtronic of promoting the medical device for uses other than what it has been approved for.
Senator Charles Grassley is concerned that medical device companies and pharmaceutical companies are crossing the line in subtle ways. Grassley has vowed that his committee will investigate if Medtronic has attempted to entice doctors to use its Infuse Bone Graft product.
This is an ongoing issue with consumer safety implications. The medical device industry is a $189 billion industry and companies seek to increase profits. If they have to skirt the law to do so, it appears most will take their chances. This isn’t a good sign for the consumer.