In 2008 there was a recall of 25,000 X-Stop devices due to a risk of the implant’s wing assembly breaking on insertion. Another event logged in the FDA’s Medical Devices database, in 2009, reports an adverse reaction in one patient and the subsequent removal of the two X-Stops with a laminectomy performed in order to stabilize the patient’s condition. The patient had numerous complications prior to the device being implanted and it appears that the adverse reaction remains unattributed directly to the X-Stop. Degenerative changes in the spine such as a possible fracture and disc damage corresponded to the patient’s condition prior to surgery. No other adverse reactions are listed in the FDA’s records although other concerns about the device have been noted in the medical literature.
Many trials have found the implant to be highly effective in treatment for spinal stenosis in a significant number of patients, although there are a number of concerns which prevent some patients from undergoing this procedure including:
- allergy to titanium or titanium alloy
- ankylosing spondylitis, spondylolisthesis, fractures of the spinal process or pars interarticularis, or scoliosis
- widespread stenosis of several spinal levels
- cauda equina syndrome with bowel or bladder dysfunction
- severe osteoporosis
- previous laminectomy or spinal anatomical abnormality
Those with spondylolisthesis have an extremely high likelihood of having to have secondary surgery (58% in a study by Verhoof, et al, 2008), and symptom-relief appears to only last in the short term, with a third of patients experiencing no relief at all.
Review of the XStop System
A review of the X-Stop Interspinous Process Decompression System by Barbagallo (et al, 2009) looked at complications arising from the treatment and concluded that careful attention needs paying to each individual patient’s anatomy before assessing the appropriateness of the procedure. In their review they noted the lack of data about complications with this device, and highlighted some key areas of concern including features of the spinous process (SP) and interspinous areas in patients which can lead to SP fractures, and device dislocations. Facet joint hypertrophy, a posterior V-shaped interspinous area, limited accessibility of the space between the base and the apex of the SP, and significantly smaller interspinous distances all increased the likelihood of an unsatisfactory outcome using the X-Stop in Barbagallo’s (et al, 2008) review.
Complications form XStop Procedures
Possible complications that may arise include spinous process fracture, the need for additional surgery, incorrect positioning of the implant which may then increase pain, failure of the device to relieve symptoms, allergic reaction to the titanium, and mechanical failure of the implant, along with the potential for the device to simply fail to alleviate symptoms of lumbar spinal stenosis. Some patients may require a further back surgery to relieve their symptoms if the X-Stop fails to provide the desired results. Discussing the treatment with an experienced surgeon is highly recommended for patients considering having the X-Stop implant as it may be that their anatomy and condition precludes them from the treatment or increases the risk of failure using this procedure, with laminectomy a better option in their circumstances.
General Surgical Risks
General risks of surgery exist, and those undergoing the procedure using a general anaesthetic should note the potential for adverse reaction to the anaesthetic, respiratory complication, and cardiovascular issues. Thrombophlebitis is also more likely when having a surgical procedure under general anaesthetic. If local anaesthetic is used then the patient may experience some pain and discomfort during the procedure itself, which they should alert their surgeon to as further medication may be available to numb the pain. Blood clots, infection, bruising, and bleeding are also risks with any type of surgery, however minimally invasive. In rare circumstances the patient may suffer paralysis, stroke, heart attack, or death, but risks are minimized by the brevity of the X-Stop procedure, the use of local anaesthetic, and the lesser degree of trauma inflicted on the body’s tissues.
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