Overview: Infuse, a synthetic bone growth product manufactured by Medtronic, is associated with a male sterility, cancer, excess bone growth and other serious complications. The risk of side effects is especially high when the product is used for unapproved or “off-label” purposes, which account for most Infuse procedures. Medtronic has been in the midst of controversy over the product, particularly following reports showing that the company manipulated studies to portray Infuse in a positive light.
- Medtronic Infuse is linked to serious side effects such as male sterility, cancer and excess bone growth
- A report by the US Senate Finance Committee shows that 11 studies were edited by Medtronic employees; none of the studies mentioned side effects
- Dr. Harlan Krumholz, professor of medicine at Yale University is leading a review of Infuse; Dr. Krumholz states that published studies are often biased and is advocating for neutral, truly independent research not influenced by the industry
Product: Medtronic Infuse Bone Graft
Manufacturer: Medtronic, Inc.
Side Effects & Complications
- Difficulty breathing, swallowing
- Uncontrolled bone growth
- Nerve injury
- Male sterility
- Retrograde ejaculation
Infuse Linked to Serious Complications
In June 2011, the Spine Journal dedicated an entire issue to the side effects seen in Medtronic Infuse patients. The research was conducted by a group of spine experts led by Dr. Eugene Carragee, who is editor in chief of the journal and chief of the Spine Surgery Division at Stanford University Medical School. According to the publication, Infuse was associated with cancer, retrograde ejaculation and male sterility, back and leg pain, infection, swelling of the neck and throat and difficulty breathing. The authors expressed concerns about industry-funded research, point out the fact that none of Medtronic’s studies on Infuse mentioned these side effects.
Recent evidence also suggests that Medtronic Infuse may lead to Cauda equine syndrome when the wrong amount of water or BMP (the synthetic protein used to stimulate bone growth) powder are mixed together. Cauda equine syndrome is when nerves at the base of the spine are compressed; it is a surgical emergency and it untreated it can cause permanent loss of bowel and bladder control and leg paralysis.
Senate Report Shows Medtronic-Funded Studies are Biased
Late last year, the United States Senate Finance Committee issued a report showing that Medtronic employees helped write and edit 11 studies promoting the use of Infuse. The so-called ghostwriting is considered a breach of integrity, as research is supposed to be unbiased and transparent. Dr. Harlan Krumholz, a professor of medicine at Yale University, told Bloomberg “Sometimes what you are reading about in a study may not be everything…We have to change the way this kind of science has been conducted.” Dr. Krumholz is leading the Yale review of Infuse