Cauda Equina Syndrome, Extremely Serious Medical Condition, Potentially Linked to Medtronic Infuse

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Cauda Equina, Extremely Serious Medical Condition, Potentially Linked to Medtronic InfuseOverview: Cauda equina syndrome is a very serious medical condition caused by the compression of nerves at the end of the spinal cord. Patients who have cauda equina syndrome often need immediate surgical treatment in order to prevent complications such as incontinence and potentially permanent paralysis of the legs. Reports submitted to the U.S. Food and Drug Administration (FDA) and information presented at the Annual 2012 meeting of the American Academy of Orthopaedic Surgeons 2012 have possibly linked cauda equina to Medtronic Infuse bone graft.

  • Cauda equina syndrome is an emergency medical condition where the nerves at the end of the spinal cord are compressed
  • If left untreated, CES can lead to incontinence and permanent  paralysis of the legs
  • Cauda equine syndrome may be linked to Medtronic Infuse, a controversial bone growth product

Product: Medtronic Infuse Bone Graft

Manufacturer: Medtronic, Inc.

Side Effects & Complications

  • Cancer
  • Difficulty breathing, swallowing
  • Uncontrolled bone growth
  • Nerve injury
  • Male sterility
  • Retrograde ejaculation

Causes of Cauda Equina: Potential Link to Medtronic Infuse

Cauda equina syndrome tends to occur more often in adults than in children. According to WebMD, the most common cause of CES is a ruptured disc in the lumbar area. The condition can also be caused by narrowing of the spinal canal (stenosis), a spinal lesion or tumor, infection, inflammation, hemorrhage  or fracture of the spine, or as a complication from a severe lumbar spine injury.

There may also be a potential link between cauda equina syndrome and Medtronic Infuse, particularly when BMP-2 (the genetically engineered protein used in the product) drips into the spinal column or nerves, when too much BMP-2 is used, or when too much water is added to the BMP powder when it is reconstituted before surgery. In the AAOS 2012 Annual Meeting, one doctor presented a case study of a 57-year old woman who developed cauda equina syndrome after her surgeon used Medtronic Infuse. The FDA’s MAUDE Adverse Event Report System also cites the case of a patient who developed CES following treatment with Infuse.

Medtronic Infuse has become a highly controversial product due to reports that the company paid doctors to hide serious side effects such as male sterility and cancer. A recent Senate report showing that Medtronic had helped write and edit positive Infuse studies has only refueled the issue. Dr. Harlan Krumolz, professor of medicine at Yale University, has been commissioned as an independent researcher to study the side effects associated with Infuse. When told of the latest Senate report, he stated that “This sounds eerily familiar to many of the transgressions we’ve read about from the pharmaceutical industry,” He went on to say that “It paints a picture of a company very heavily involved in the science; marketing contaminating the science; and the medical profession and researchers being complicit…It’s no wonder the public has lost confidence in the drug and device industries.” according to MedPage Today.

What are the Symptoms of Cauda Equina Syndrome?

Cauda equina syndrome can be difficult to diagnose, because symptoms can vary between patients and come on slowly. CES symptoms can also appear similar to other conditions. If you experience any of these symptoms, seek medical attention immediately:

  • Severe pain in the lower back
  • Pain, numbness or weakness in one or both legs
  • Loss or altered sensations in the legs, buttocks, inner thighs, backs of your legs or feet that gets increasingly worse (saddle anesthesia)
  • Bladder or bowel dysfunction, incontinence or trouble with elimination
  • Sudden onset of sexual dysfunction