Medtronic the manufacturer of Infuse is accused of manipulating information about it’s product.
Infuse acts as the scaffold in a surgical bone grafting procedure. Infuse is a two part system consisting of a protein found in the body, and a sponge manufactured from a cow type 1 collagen. The sponge releases the protein over time to aid in new bone growth. The sponge is then absorbed by the body and replaced by bone.
Infuse was approved by the FDA (Food and Drug Administration) in 2002 for one singularly specific type of spinal surgery – An anterior approach lumbar fusion of one level of the spine between the L5 and S1 vertebrae. However, some surgeons have used Infuse for unapproved procedures called, “Off-Label” procedures.
Patients who received Infuse in “Off-Label” procedures have suffered adverse effects, including:
- Sterility
- Retrograde ejaculation
- Uncontrolled bone growth at or near the site of the surgery
- Ongoing or chronic radiating pain in the legs or arms
- Uro-genital injuries in male patients
- Increased risk of cancer
- Acute severe neck swelling – resulting in permanent injury or even death
In a report by Reuters News Service:
“There were questionable ties between Medtronic and physician consultants who tested and reviewed the company’s product, the U.S. Senate Finance Committee said in the report, which concludes a 16-month investigation covering 5,000 documents relating to 13 studies of Infuse.
“Medtronic paid about $210 million dollars in royalties and consulting fees to the authors of company-sponsored studies between November 1996 and December 2012.
“Those sponsored studies failed to mention complications from the product, including male sterility, an increased risk of cancer, infections, bone dissolution and worsened back and leg pain.”
Although, “Medtronic vigorously disagrees with any suggestion that the company improperly influenced or authored any of the peer-reviewed published manuscripts discussed in the report.”
It is alleged that Medtronic has either fraudulently or negligently misrepresented the benefits and risks of Infuse, and that Medtronic improperly and illegally promoted and marketed Infuse for “Off-Label” use.
If you feel you are the victim of “Off-Label” use of Infuse, we can help. Contact The Maher Law Firm and/or Frank Eidson to discuss your potential Infuse Lawsuit with an experienced attorney.
