Medtronic has been accused of paying off doctors and hiding dangerous Infuse Bone Graft side effects from consumers. Due to these allegations, lawsuits have been filed against Medtronic by Infuse bone graft patients across the nation.

What is an Infuse Bone Graft?

The Infuse Bone Graft  consists of two primary parts, a protein that promotes bone growth and a delivery system for the protein. The protein used in Infuse  is known as rhBMP-2. It is a genetically engineered version of a naturally occurring protein that promotes healing and new bone growth in all humans. The Infuse bone graft delivery system is a sponge made out of bovine collagen. The device is designed to release the growth hormone over time and serves as a structural frame for new bone growth.

The Infuse Bone Graft device is meant to eliminate the need for an additional bone harvesting surgery for patients undergoing spinal surgery. Traditionally, bone is harvested from a patient’s hip. This harvesting surgery can be painful and can cause various additional complications. The majority of grafts are used to alleviate back pain in a procedure known as spinal fusion, where individual damaged vertebrae are fused together to form one solid bone, eliminating nerve irritation in the spine.

Medtronic’s Infuse Bone Graft system was approved by the FDA for spinal surgeries in 2002. Medtronic is an industry leader in bone graft and bone re-growth devices.  Since 2002, Infuse has also been approved for use in tibial fractures and dental procedures.

Overview of Medtronic Infuse Bone Graft Lawsuits

In 2012, Medtronic underwent a year long investigation by the US Senate Finance Committee. The investigation looked into whether Medtronic had falsely advertised its products and whether Medtronic had given kickbacks to medical professionals to promote the sales of its products. The investigation found that large consulting fees had been given to researchers who were looking into the effectiveness of the drug. Although it is illegal for a drug or device manufacturer to market their products for non-FDA approved (off label) uses, it is not illegal for doctors to use products in off label ways. Many of the lawsuits filed allege that Medtronic paid doctors to promote Infuse Bone Graft for off label uses and hid various dangerous side effects from consumers.

Patients bringing Medtronic Infuse Bone Graft lawsuits have suffered various injuries due to both off label and traditional uses of the device. These complications and injuries include difficulty breathing and speaking, serious chronic pain, excessive bone growth, nerve damage, male sterility, and death.

Infuse Bone Graft lawsuits have been filed in both state and federal court. Plaintiffs filing suit are direct victims of the bone growth device and family members of loved ones who have died due to complications associated with the Infuse Bone Graft. For many victims, these lawsuits may help pay extensive medical bills and serve as an attempt to compensate for the pain and suffering they experienced due to the device complications. Many people hope that lawsuits such as these will help keep pharmaceutical companies honest and encourage them to disclose known side effects of drugs and medical devices as soon as they are discovered.