Medtronic Infuse Cancer Side Effects. Research has indicated that there may be a strong association with Medtronic Inc.’s Infuse Bone Graft product, and cancer, specifically:
- Prostate Cancer
- Breast Cancer
- Pancreatic Cancer
Recently, reports have also raised questions about Medtronic’s handling of clinical trial data that may indicate patients implanted with Infuse face a higher risk of prostate, breast, pancreatic and other cancers.
The defective drug lawyers at Parker Waichman LLP are investigating the association between Medtronic Infuse Bone Graft and cancer. If you or a loved one received Infuse during spinal surgery, and were later diagnosed with cancer, especially breast, pancreatic or prostate cancer, filing a Medtronic Infuse cancer lawsuit may enable you to obtain compensation for your medical bills, lost wages, pain and suffering, emotional distress and other damages.
If you believe Medtronic Infuse could have caused you to developed cancer, we urge you to contact our Medtronic Infuse cancer lawyers today.
Medtronic Infuse Cancer Side Effects
Medtronic’s Infuse product is a bioengineered bone-growth protein used in spinal surgery called recombinant human Bone Morphogenetic Protein (rhBMP-2). This protein occurs naturally in the human body, and is known to stimulate bone growth.
When it was first approved by the U.S. Food & Drug Administration (FDA) in 2002, Infuse was hailed as a major advance in spine surgery. However, since that time serious questions have been raised about its safety, and Infuse is now the subject of numerous regulatory investigations.
The possibility that rhBMP-2 might promote cancer has been a concern ever since it was brought to market because it is a growth factor that causes cells to proliferate.
Infuse is approved for use in a type of spine surgery called anterior approach lumbar fusion, and two types of dental procedures. However, Infuse is widely used off-label in other spine procedures, especially cervical (neck) spine surgery, as well as in lateral approach (through the side of the body) or posterior approach (through the back of the body) spinal procedures.
In July 2008, the FDA warned that Infuse bone graft and similar products had caused serious, sometimes life-threatening, complications when they were used off-label in cervical spine (neck) surgeries. Patients reported difficulty swallowing, breathing and speaking.
Infuse’s possible association with cancer came to the fore in November 2011, when a study conducted by long-time Infuse critic, Dr. Eugene Carragee, found that within in a year of implantation, cancer risks more than doubled in Infuse patients.
At three years after implantation, the increase cancer risk grew to nearly five-fold. The study cited a number of cancers, including prostate cancer, pancreatic cancer and breast Cancer.
Carragee’s study, which was presented at the annual North American Spine Society meeting in Chicago, involved an analysis of pooled clinical trial data from Infuse, and a high-dose version of the same protein, called Amplify, which was also developed by Medtronic.
The FDA refused to approve Amplify in early 2011 because of concern over cancer risks. According to Carragee, the analysis of the Amplify trial found 20 cancer events in the rhBMP-2 group, compared with and 5 in the control group.
Three patients in the rhBMP-2 group had multiple cancers, whereas none in the control group did. Three patients in the rhBMP-2 group died of cancer, whereas only 1 in the control group did.
In an interview with The New York Times, Carragee pointed out that the Amplify findings could be important for Infuse patients, many of whom received Infuse in off-label procedures. Such procedures often require Infuses doses that are significantly above the recommended dosages, ones that approach or exceed the amount of rhBMP-2 found in a dose of Amplify, he said.
Did Medtronic Conceal rhBMP-2 Cancer Data?
During his presentation in November 2011, Carragee noted that the industry-sponsored studies upon which his analysis was based neglected to discuss the association between rhBMP-2 and cancer. An investigative report published by the Milwaukee Journal-Sentinel and MedPage Today in October 2011 also raised serious questions about the omission of cancer data in the Amplify clinical trial when it was published in the Journal of Bone and Joint Surgery in 2009.
The investigation found when the study’s authors were preparing to publish their article, they discovered that the number of cancer cases among patients treated with rBMP2 had crossed the threshold for statistical significance.
However, this information was left out of the article’s discussion section in the final submitted manuscript. Cancer was only addressed in a single line in a table the accompanied the article, and even then, many worrisome cancers were omitted.
The Journal-Sentinal /MedPage investigation also revealed:
- The published paper reported there were eight patients who were diagnosed with cancer 24 months after being treated with Amplify, compared with two patients who got the standard treatment. That number of cases fell just below what would have been considedred “statistically significant.” However, records submitted to the FDA indicated there were really 9 cases of cancer reported among Amplify patients, which would have made the risk significant.
- An analysis of cancer cases reported at 3 years conducted at the behest of the Journal-Sentinel and MedPage found that 12 Amplify patients had developed the disease, verses just three in the control group. Medtronic’s researchers did not conduct a three-year analysis when they published the study.
- In the 2009 published paper, the authors concluded there was no significant difference in serious complications between those patients got rhBMP-2 and those who did not. However, the data was presented differently to the FDA when Medtronic applied for approval of Amplify. At that time, there was a “full airing of the cancer question in more than 1,000 pages of FDA records,” the Journal-Sentinel and MedPage reported. The cancer findings ultimately caused the agency to reject Amplify.
- FDA records also indicated that a separate analysis of all of 18 of Medtronic’s clinical trials using rhBMP-2 showed a trend toward high cancer rates, the Journal-Sentinel and MedPage said. That analysis found that 2.4% of BMP-2 patients got cancer, compared with 1.4% who did not get BMP-2. In four, high-dose clinical trials of BMP-2, 3.6% patients developed cancer.
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