Embattled medical device giant Medtronic Inc is feeling the heat again, as reported on www.devicespace.com. This time it is alleged that the company has encouraged off-label use of its Infuse bone graft resulting in a personal injury lawsuit after the material has apparently caused bone growth in or around the spinal cord. This again draws attention to the whole subject of off-label use of medical devices. The product is designed and FDA approved for anterior approach spinal fusion, yet has seemingly found its way into other approaches and areas of the spine for which it is not approved. We’ve all seen and had these discussions before….. just take a look at this link on Spineblogger and you’ll see all views, from corporate consiracy theory to FDA incompetence to technical incompetence. The fundamental question of whether a surgeon can extend the application of a seemingly successful material into areas for which it is not specifically approved is a thorny one. The issue here is whether the company actually promoted its use, which no doubt will come out in due course. The essence of the article follows, with the full article on devicespace being found by clicking here.
Wendy R. Fleishman of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, announced that Jennifer English of Lake Worth, Florida, filed a personal injury lawsuit against Medtronic, Inc. In August 2007, English, a physical therapist, was implanted with Medtronic’s Infuse Bone Graft (“Infuse”) during a posterior-approach lumbar spine surgery, a type of surgery for which the Food and Drug Administration has not approved Infuse. English charges that Infuse caused her to develop ectopic, or uncontrolled, bone growth in her spine, compressing nerves and leading to chronic and ongoing severe pain.
“The complaint alleges that Medtronic fraudulently misrepresented the risks and benefits of Infuse and improperly promoted and marketed Infuse for non-FDA approved uses,” stated attorney Fleishman. “When Infuse is implanted in off-label surgeries, medical research shows that it can cause uncontrolled bone growth into or around the spinal cord, often leading to intractable pain and difficult and dangerous revision surgeries to remove unwanted bone.”
English has been forced to undergo two revision surgeries so far to remove the excessive bone growth, including an emergency surgery. She suffers continuous pain in her back and legs from ordinary everyday activities, such as sitting or standing for extended periods of time.
Source: www.devicespace.com
published: September 21, 2011 in: Medtronic, Regulatory, USA