Parker Waichman LLP

Medtronic Infuse Associated with Higher Rate of Cancers than First Believed

Higher Rate of Cancers Noted In Lawsuits. Dr. Eugene Carragee, a Stanford University School of Medicine professor and editor of The Spine Journal. has raised more questions about Medtronic Inc.’s Infuse bone growth product. According to Carragee, Infuse may be more strongly associated with cancer than previously thought. In June, a Spine Journal article authored by […]

Medtronic-Infuse

Higher Rate of Cancers Noted In Lawsuits. Dr. Eugene Carragee, a Stanford University School of Medicine professor and editor of The Spine Journal. has raised more questions about Medtronic Inc.’s Infuse bone growth product. According to Carragee, Infuse may be more strongly associated with cancer than previously thought.

In June, a Spine Journal article authored by Carragee reported that Medtronic-paid surgeons had failed to report serious complications from Infuse, including cancer, sterility in men, infections, bone dissolution and worsened back and leg pain.

The article said complications occurred in 10 to 50 percent of patients who got the product in 13 Medtronic-funded clinical trials between 2000 and 2010.

Medtronic clinical trial raised serious concerns

Yesterday, during a presentation at North American Spine Society meeting in Chicago on Thursday, Carragee said a new analysis he performed of another Medtronic clinical trial raised serious concerns about a cancer risk posed by rhBMP-2, the bone growth protein found in Infuse.

According to Carragee, his analysis of a Medtronic-funded study that involved 239 patients who got the company’s Amplify product and 224 who got a conventional graft of their own hip bone indicated a strong connection between the protein and cancer.

At roughly three-year follow-up, 5% of those who got Amplify were diagnosed with a new cancer, compared with 1.3% who got the hip bone graft. After two to three years of follow-up, Amplify patients were four to five times more likely to develop at least one new malignancy.

Like Infuse, Amplify is made with rhBMP-2, but at higher dose.  In March, the U.S.  Food & Drug Administration (FDA) declined to approve Amplify because of cancer concerns.  However, when the Amplify study analyzed by Carragee was published in 2009, the text never mentioned the cancer cases, and they were only noted in an accompanying table.

The authors – who had received millions in royalties for other Medtronic products – claimed they weren’t statistically significant, something Carragee disputes. By his reckoning, patients who received rhBMP-2 were three to five times more likely to develop cancer within a few years of implantation.

cancer findings could have serious implications

In an interview with The New York Times, Carragee said the cancer findings could have serious implications for people receiving Infuse.  Doctors often administered Infuse off-label at levels significantly above the recommended dosages, ones that approach or exceed the amount of rhBMP-2 found in a dose of Amplify, he said. Carragee also voiced particular concern about the use of Infuse in certain patients like smokers or those with genetic factors that put them at higher risk for cancer, the Times said.

Need Legal Help Regarding Medtronic Infuse?

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness , Value
Edith Barrow
2 years ago
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness , Value I would like to thank Ms. Tina Morace for all her work on my claim. She was always effective and diligent during the process and I was always in the loop. Again, thank you and I recommend Parker/Waichman, LLP for all your legal needs...
Pamela Felts
3 years ago
5 Star Reviews 150
I am satisfied with the service I received from Parker Waichman LLP, I am submitting a review of the excellent service that I received from Ms. Benita Rollis. I depended on her expertise regarding legal matters. She was very attentive to my concerns and answered any questions that I had. Ms. Rollis has great customer service skills that includes a positive attitude and patience . She is a valuable asset to Parker Waichman LLP. Sincerely, Ms. Angela Jones
Angela Jones
3 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard, Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375