Overview: Parker Waichman LLP, a national personal injury firm, is warning spinal fusion patients about Medtronic Infuse Bone Graft. In a press release issued today, the firm said that patients should contact their surgeons to find out if the product was used. Medtronic Infuse is an artificial bone graft that has been linked to a number of complications, including cancer, male sterility and nerve damage. The product came under fire when Medtronic was accused of promoting off-label use and paying doctors to hide these side effects.
- Parker Waichman advises spinal fusion patients to contact their surgeons to find out whether or not they used Medtronic Infuse
- Medtronic infuse is approved to stimulate bone growth in the lower spine, but it has been used in the cervical and other unapproved areas; the FDA has warned that this off-label use can result in fatal complications
- Last June, the Spine Journal dedicated an entire issue to exposing the side effects associated with this product, suggesting that industry-sponsored research underestimates serious complications
Product: Medtronic Infuse Bone Graft
Manufacturer: Medtronic, Inc.
Side Effects & Complications
- Difficulty breathing, swallowing
- Uncontrolled bone growth
- Nerve injury
- Male sterility
- Retrograde ejaculation
Medtronic Infuse and Off-Label Use
In July 2002, the U.S. Food and Drug Administration (FDA) approved Medtronic Infuse to stimulate bone growth in a procedure known as anterior approach lumbar fusion. This type of surgery operates on the lower regions of the spine and is performed through the front of the body. Any other method is considered “off-label” use, which is illegal for companies to promote, but not for physicians to perform.
According to Parker Waichman’s press release, approximately three-quarters of the 200 Infuse complaints received by the FDA involved off-label procedures. In 2008, the agency warned that using Infuse in the cervical spine was associated with life-threatening complications such as swelling of the neck and throat tissue, which may compress the airway and neurological structures.
There have also been shareholder lawsuits alleging that Medtronic paid doctors to use Infuse off-label. Medtronic settled one such suit in March for $85 million.
Spine Journal Study
Last June, the Spine Journal published an entire issue analyzing the side effects linked to Medtronic Infuse. Lead author and Editor-in-chief Eugene Carragee found that the bone growth product was associated with male sterility, retrograde ejaculation and other complications. Furthermore, researchers indicated that the Medtronic doctors downplayed these side effects in their own research.
High Doses Linked to Cancer
Last fall, Dr. Carragee presented research findings suggesting a link between rhBMP-2, the protein used in Infuse, and cancer. He investigated a high-dose version of Infuse known as Amplify, and found that the risk of cancer was two and a half times more likely after one year and five times more likely after three years.