Medtronic's Bone Graft, InFuse, Causes Retrograde EjaculationJul 5, 2013
Retrograde ejaculation is a potential side effect associated with the Medtronic bone graft InFuse.
When ejaculate is forced backwards into the bladder—this would occur because the bladder neck is unable to appropriately react—and not through the urethra and out of the penis, which is the typical route, retrograde ejaculation has occurred. When working properly, the bladder neck tightens to prevent ejaculate from entering the bladder and also holds urine in the bladder until urination.
Retrograde ejaculation is seen in males diagnosed with diabetes and who suffer from diabetic neuropathy, following specific surgeries, or as a result of some mood disorder medications. Retrograde ejaculation is also a known side effect of Medtronic’s InFuse bone graft product.
Symptoms of retrograde ejaculation include:
- Cloudy urine following orgasms, a result of semen backing into the bladder and the urine containing semen
- Dry orgasms in which little or no semen is released out of the penis during ejaculation
- Male infertility
A synthetic, or genetically engineered, recombinant human Bone Morphogenetic Protein (rhBMP-2)—InFuse was approved by the U.S. Food & Drug Administration (FDA) in 2002 to stimulate spine growth in patients suffering from lower spinal degenerative disease. InFuse is approved for use in one type of spinal surgery and some dental procedures and is not approved for use on the upper, or cervical spine, where it is now widely used in off-label procedures. In fact, the agency released a July 1, 2008 notification warning that InFuse had been associated with serious complications when used in cervical spinal fusions.
InFuse side effects include:
- Retrograde ejaculation
- Male infertility, sterility
- Uncontrolled bone growth
- Bone dissolution
- Gastrointestinal Problems
- Excessive swelling in the neck
- Compressed airways
- Difficulty swallowing, breathing, and/or speaking
- Nerve injuries and nerve damage
- Cauda Equina Syndrome (“Horse Tail” Syndrome)
- Pain, chronic pain
- Swelling of the neck resulting in injury or death
- Increased cancer risks
- Worsened back and leg pain
InFuse has been the focus of growing controversy over Medtronic’s marketing practices, which many have viewed as questionable, and with issues related to how approval for InFuse was based on Medtronic-funded research. Medtronic has been accused of touting Infuse off label and of downplaying the device’s risks while overstating its benefits. As a result, there has been a Senate probe, the FDA warning, and two recently released independent studies.
Senate investigators charged that Medtronic deliberately manipulated studies to downplay adverse reaction data associated with InFuse, while promoting its off label uses. The U.S. Senate Finance Committee also found issues with most of the initial Medtronic-supported InFuse research used to promote the product and a special 2011 publication of The Spine Journal was devoted to reports that critiqued research conducted by surgeons who received millions of dollars from Medtronic. The journal accused Medtronic of not reporting serious complications associated with InFuse.
The two independent and recently published studies found that InFuse is no better than traditional, patient-harvested bone grafting and is also associated with serious risks, including increased cancer risks.