Parker Waichman LLP, a national law firm, is warning spinal fusion patients about complications associated with Medtronic Infuse Bone Graft. The law firm is also currently investigating potential lawsuit claims that involve Medtronic Infuse Bone Growth side effects, including overgrown bone, male sterility, retrograde ejaculation, the need for revision surgery, and cancer.
Parker Waichman LLP is advising patients who underwent spinal fusion surgeries to contact their surgeons to determine if Medtronic Inc.’s Infuse Bone Graft product—also known as rhBMP2—was used in their procedure. According to the firm, the U.S. Food & Drug Administration (FDA) issued a safety alert in 2008 warning that Infuse Bone Graft had been associated with serious complications when used in cervical spine fusions, including excessive swelling in the neck, compressed airways, difficulty breathing, problems swallowing, and nerve damage. Parker Waichman LLP is now investigating potential claims involving a number of potential Medtronic Infuse side effects, including:
- Ectopic or uncontrolled bone growth
- Ongoing or chronic radiating pain in the legs or arms
- Male sterility
- Retrograde ejaculation
- Nerve injuries causing severe and chronic pain
According to Parker Waichman LLP, Medtronic Inc.’s Infuse Bone Graft is made from a genetically engineered material called rhBMP-2 (recombinant human Bone Morphogenetic Protein-2), which stimulates bone growth. Infuse was approved by the FDA for use in only one type of spine surgery called anterior approach lumbar fusion, and two types of dental surgeries. The Wall Street Journal reported in September 2008 that at least three-quarters of the roughly 200 Infuse adverse events reported to the FDA at that time involved uses not approved by the agency. According to the FDA, the cervical spine fusion surgeries cited in its 2008 alert involved off-label Infuse procedures.
In addition to the injuries noted in the FDA’s alert, Infuse has been linked to a number of other serious side effects. A May 2011 New York Times report indicated that a study conducted by Stanford University surgeon Dr. Eugene J. Carragee revealed that men treated with Infuse developed sterility-related complications at a far higher rate than men who received a traditional bone graft. In November 2011, the Times also reported that another analysis conducted by Dr. Carragee found that the high doses of Infuse often needed in off-label procedures could be associated with increased cancer risks.
As we’ve written, Medtronic has faced charges that it downplayed the rate of some serious side effects in some of its sponsored research for Infuse. In fact, last year, the Spine Journal raised serious questions about the validity of research used to gain FDA approval of Infuse. According to a critical analysis of 13 Medtronic-sponsored clinical trials for Infuse published by the Journal, the studies failed to report serious complications, including cancer, retrograde ejaculation, sterility in men, infections, bone dissolution, and worsened back and leg pain, in patients treated with Infuse.