The Medtronic Infuse Bone Graft is a medical device used to treat certain medical complications. However, the Medtronic Infuse Bone Graft has been linked to several adverse medical risks. In addition to the risks associated with the Infuse bone graft, Medtronic has been accused of paying consultants to release favorable reports about the Infuse Bone Graft.
U.S. Senate and Finance Committee Investigation into Medtronic Reports
In June 2011, the U.S. Senate and Finance Committee started looking into Medtronic's fabricated reports about the Infuse bone graft. They further began investigating whether Medtronic failed to release information regarding the adverse risks associated with the use of their product. In October of 2012, the Senate and Finance Committee concluded that Medtronic played a role in “shaping 13 key studies of InFuse, which helped turn the bone graft into an $800-million a year product.” Moreover, Medtronic allegedly “failed to mention serious risks of InFuse including male sterility, infection and increased back and leg pain.”
Medtronic disagrees with the Senate Finance and Committee’s findings and denies that they “improperly influenced or authored any of the peer-reviewed published manuscripts discussed in the report, or that Medtronic intended to under-report adverse events.”
What is the Medtronic Infuse Bone Graft?
The Medtronic Infuse Bone Graft is a medical device marketed by Medtronic. The FDA approved it in 2002 to treat the following:
- Medical complications involving the lumbar spine (lower spine)
- Medical complications involving oral and dental procedures
- To treat degenerative disc disease
- To treat certain fractures to the tibia (the bone connecting the knee to the ankle)
Additional Information About the Medtronic Infuse Bone Graft:
- Medtronic Infuse Bone Graft was approved by the FDA in 2002 to treat only certain medical complications. However, medical professionals were using the Medtronic Infuse Bone Graft in cervical spine operations which was not approved by the FDA. In July 2008, the FDA issued a warning about the risks involved when the product is used off-label, meaning not used for its approved purposes.
- Numerous patients who underwent treatment with the Medtronic Infuse Bone Graft reportedly experienced adverse medical complications.
Common Adverse Risks Associated with Medtronic Infuse Bone Graft:
- Retrograde ejaculation
- Respiratory complications, including difficulty breathing, swallowing, and respiratory depression
- Nerve damage
- Wrongful death
- Chronic pain
- Difficulty speaking
To learn more about Medtronic Infuse Bone Grafts, visit our Frequently Asked Question’s page.
How Can a Medtronic Infuse Bone Graft Lawyer Help?
If you or a loved one has suffered side effects caused by the Medtronic Infuse Bone Graft, you may be entitled to compensation for your injuries. You should consult with a Medtronic Infuse Bone Graft attorney to determine whether you have a valid legal claim. Most of the attorneys at LawInfo.com offer free initial consultations.
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