05242017Headline:

Omaha, Nebraska

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Craig Kelley
Craig Kelley
Attorney • (800) 642-1242

SynchroMed Medication Pumps

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SynchroMed implantable medication pumps are utilized for patients whom it benefits to have pain drugs directly delivered to cerebral spinal fluid when they have pain conditions that are intractable, or when they experience severe spasticity symptoms not alleviated by prescribed oral medications. Such medication delivery also has the purpose of helping patients receive the medication without the fatigue side effects that occur with oral or injected medications that have to travel throughout the body. While this might sound like a fairly noninvasive way to experience pain relief, there have been dangerous problems with the pump manufactured by Minneapolis-based Medtronic.

The most dangerous condition suffered by use of the SynchroMed pain pump involves a condition termed, catheter tip inflammatory mass lesion formation (granuloma), which occurs when this intrathecal granuloma forms around the catheter tip within the spinal canal. The results can, at the milder spectrum, be that patients will experience less pain relief. At the severe end of the results spectrum, patients can experience neurological dysfunction, muscle weakness, or paralysis. Death has also occurred (fourteen reported deaths as of June 27, 2013). While studies estimate that the incidence of this unwanted side effect of the SynchroMed pain pump is around three percent, one cannot think this is positive when it is also estimated that the percentage is expected to get larger and larger as the use of pain pumps is increasing and the time the pain pumps remain implanted is also increasing.

It is not comforting to be told that so far physicians and pain pump manufacturers are not sure why the dangerous complications of the implanted SynchroMed is occurring. Besides Medtronic, pain pumps are also manufactured by Johnson & Johnson (IsoMed) and other companies (InSet Technologies). It is also thought that many of the granuloma cases are not reported, so the current number of cases could be higher than estimated. The drugs that the Federal Drug Administration has approved for use with the pain pumps is limited to Morphine, Ziconotide (Prialt, Elan), and Baclofen. The first two drugs are used for pain and the Baclofen is used for spasticity. Morphine may be the drug most likely to cause granuloma with the pumps. However, physicians often utilize the pain pumps with compound infusions and so one must add the drugs, Hydromorphone, Clonidine, Bupivacaine, Fentanyl, and Sufentanil to the list, among others individually customized by individual physicians.

While the FDA and Medtronic have been fairly active in trying to warn physicians and patients regarding the best uses for, and dangers of, the pain pumps, the fact is they are still approved, still being used frequently, and still have the potential of being dangerous. If you or a loved one has experienced complications with the use of any of the pain pumps, call Inserra & Kelley for caring, expert advice on patient rights and options.