Monica (not her real name) spent thousands of dollars and many hours with the chiropractor and physiotherapist before her lower back pain became unbearable - the pain was shooting down her legs from the L4 and L5, due to degenerative disc disease. She found a surgeon with a solid reputation, or so she thought, and underwent an eight-hour surgery using the Infuse bone graft.
“After three months I returned to work,” says Monica. “The pain was gone so in that regard I thought the surgery was successful, but there was still some weakness in my leg and I could feel a shooting pain a few times a day, which I could live with. But my mobility was affected - and that was something new. I couldn’t bend down to reach the bottom shelf of my closet; I could only bend to a certain point and couldn’t go any further.”
Monica hadn’t been referred to physical therapy so instead she went swimming at the YWCA and she walked a lot. This wasn’t easy having two children and a full-time job but she went religiously every day. But by Christmas Eve the back pain had worsened. She had more x-rays and went back to the surgeon for the one-year follow-up.
“He studied the x-ray and said everything was fine,” says Monica. “I asked him why I had so much pain if everything was fine. He just told me to continue exercising. By the fall of 2013, I called him again - something was very wrong. I insisted on getting a CAT Scan and an MRI but couldn’t get the results from my surgeon. He conveniently was unavailable for several months, even though my husband kept calling.
“Out of desperation I went to a pain management doctor, on my doctor’s advice. He gave me injections and read the CAT Scan and MRI reports - that is how we found out the bones hadn’t fused. When my husband finally reached the surgeon, he admitted it hadn’t fused and I needed revision surgery.
“We were furious. And it gets worse. My husband called the surgeon again. ‘Also the results indicate further damage to lower level,’ said my husband. ‘I don’t see that,’ said the surgeon.
“When I was on winter break I couldn’t take the pain anymore and got a second opinion. This surgeon was appalled. ‘In all my years of practice I can tell you that this type of back surgery you had was way too radical; I have only seen that surgery performed twice, when absolutely necessary,’ he said, adding that my surgery should have only taken two hours. He then showed me the device he uses, and it isn’t Medtronic.”
Monica wants to sue the surgeon for medical malpractice and she has also filed a claim against Medtronic.
In 2002, the FDA approved Medtronic for limited use. Monica had fusion of L4 and L5, which would have been off-label. Hundreds of Medtronic lawsuits have been filed, all alleging off-label marketing of the Infuse device. Almost 1,000 more cases are in the investigation stages.
READ MORE MEDTRONIC INFUSE BONE GRAFT LEGAL NEWS
In another Medtronic lawsuit, the plaintiff is suing both Medtronic and her surgeon, arguing that she was not told until after the procedure that the Medtronic device was used in ways not intended on the label; in other words the procedure was performed “off-label” and not approved by the FDA.