It seems that Medtronic’s InFuse spinal graft helps back injury stabilize but may contribute to a condition in which semen goes into the bladder after ejaculation instead of leaving the body through the urethra and can lead to eventual infertility.
A malfunctioning bladder sphincter, leading to retrograde ejaculation, may be a result of the autonomic nervous system or the operation of the prostate. It is a common complication of transurethral resection of the prostate, a procedure in which prostate tissue is removed, slice by slice, through a resectoscope passed along the urethra. It can also be caused by a retroperitoneal lymph node dissection for testicular cancer if nerve pathways to the bladder sphincter are damaged with the resulting retrograde ejaculation being either temporary or permanent.
The Infuse product contains a genetically engineered protein that can stimulate bone growth. It attracts the body’s own bone-building cells to the site and over time, new bone is formed. Bone grows where the InFuse Bone Graft is placed, for predictable bone growth results. It is used in spinal, oral, and dental graft procedures, and is an alternative to procedures like autologous grafting, where bone is taken from elsewhere in the patient’s body.
The new study by Stanford University researchers included about 230 men who had a common type of spinal fusion procedure. Out of 69 men who received an InFuse graft, five experienced retrograde ejaculation. Out of 174 patients who were treated with other bone grafts, only one experienced retrograde ejaculation. Three of the six cases cleared up within a year, including the one in the man who did not receive an InFuse graft.
InFuse has been linked to a variety of other complications since it was approved. Medtronic’s website lists “sexual dysfunction” as one possible risk associated with spinal surgery but does not connect it specifically to Infuse.
In mid-November 2008, Medtronic disclosed that the Department of Justice, (DOJ) was investigating the off-label use of a Medtronic implant. The off-label use investigation was believed to center around the InFuse Bone Graft being used in cervical spine (neck) surgeries. The active ingredient in the InFuse Bone Graft is rhBMP, which is a protein that may be causing various potentially lethal side effects to patients within hours or days of surgery, including swelling of neck and throat tissue that can result in suffocation. Use of the InFuse Bone Graft or rhBMP in the cervical spine surgeries is clearly off-label.
The FDA has received 280 reports of side effects involving the InFuse and about three-quarters of those reports involved off-label use of the InFuse Bone Graft.
The government typically investigates claims of off-label use involving medical devices and pharmaceutical drugs because the government, through insurance programs like Medicare and Medicaid, purchases such health care products. Off-label use of the InFuse Bone Graft would likely not be covered by Medicare and any claims submitted for reimbursement to Medicaid or Medicare might require a representation that the device was used for its intended purpose and not for any off-label purpose. Because the InFuse Bone Graft is not approved for cervical spine surgery, use for that purpose would be considered off-label.
Male infertility accounts for 40-50% of all infertility in humans.
Sources: The Spine Journal,
Written by Sy Kraft