Physicians have a duty to their patients to provide all information available, including risks and benefits, about medical devices and surgical procedures. It is of the utmost importance to keep patients safe and make sure medical devices will not result in the emergence of serious, unwanted side effects.
Reuters reported that a bone growth product from Medtronic Inc., may not be as safe to use as previously stated. A review published in the Annals of Internal Medicine shows that this body implant produces a small increase in cancer risk and that initial data focused more on favorable results instead of a full review of side effects.
Doctors wrote in the piece that surgeons should reserve the Medtronic product for special cases and select patients and should explain the full list of risks associated with the bone growth implant. This product is meant to alleviate the chronic pain associated with spinal infusion surgeries. Previous to the invention of this implant, bone harvesting was used to heal the body section undergoing spine infusion surgery. This product allowed bone healing without the need to harvest skeletal parts of the body.
Two years ago, the Department of Justice and the U.S. Senate began an investigation of the bone growth device. The company Medtronic agreed to two independent reviews of clinical trial data. It was found that the device slightly increased patients’ risk of cancer and worked no better than bone that was harvested from a patient’s body.
“The findings reinforced what we know about the product in the sense that the studies concluded equivalence, and in some cases superiority, to iliac crest bone harvesting,” Chris O’Connell, president of Medtronic’s Restorative Therapies Group, told the news source. “It’s really up to the physician to interpret the data.”
In March of 2012, Medtronic was tied up in a shareholder lawsuit accusing the company of not revealing that the product’s major sales came from off-label uses. Medtronic officials paid $85 million to settle the lawsuit.
As with all devices and procedures, spinal surgeons will need to look into the background of this device and procedure before speaking to patients about new types of surgeries.