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What are the Risks of Having a Drug Pump Implanted?

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Updated September 18, 2008

Question: What are the Risks of Having a Drug Pump Implanted?
Every type of invasive pain management treatment, including implantable drug pumps, carries certain risks.
Answer:

Risks may be due to the anatomy being targeted, or the way in which the device or medication does its work, once inside the body.

Risks that come with implantable drug pumps are often caused by problems with the catheter. Between 1% to 5% of patients who have had the pump put in develop inflammatory granuloma, which is an infection at the tip of the catheter. Inflammatory granuloma is serious and requires immediate medical attention.

Other problems, often requiring a second surgical procedure, include kinking, obstruction, coiling and/or breaking of the catheter. One research study found that 25% of patients with implanted intrathecal drug pumps experience catheter-related problems.

Another area of risk with implantable drug pumps relates to the medication itself. The use of narcotics such as morphine is not only associated with the development of inflammatory granuloma, but also with respiratory depression, urinary retention and deep infection. Addiction to the narcotics is possible, although not as much as when they are taken orally.

Research
Surgeons routinely give their patients interventional pain medicine (for example, the drug pump) after an operation to control pain. The use of implanted drug delivery pumps for cancer pain is also very well established. Because of this, the risks associated with the procedure are known. While doctors seem eager to apply current knowledge about the drug pump to cases of chronic spine pain, the evidence that it relieves non-cancer non-surgical pain over the long term is lacking. Just the same, chronic back pain is now the most common use for implantable drug delivery systems.

So, the use of drug pumps for cancer and post-op pain takes place in a realm where doctors are skilled, and knowledge gleaned from medical research is abundant. But making the transition to treatment targeting ongoing neuropathic pain can be challenging. Studies can only leverage the development of implantable drug delivery up to a point, as there are many ethical and practical problems that occur when experiments that involve patients who are in a lot of pain are set up. So far, though, studies have shown that using a combination of medications in the pump, and carefully screening and selecting patients is probably the best way to walk the fine line between attaining the desired pain relief and avoiding side effects.

Sources:

Dr. Sudhir Diwan, Director Pain Medicine Fellowship Program and Director of the Division of Pain Medicine at Weil-Cornell Medical College of Cornell University. Telephone Interview. May 2008.

Jurisidictional Determinations. US Food and Drug Administration website.

Intercenter Agreements. US food and Drug Administration website.

Gould, H., III, MD, PhD, Understanding Pain: What it is, Why it Happens and How It's Managed. American Academy of Neurology. 2007. New York.

Berner, B. Dinh, S. (eds)Electronically Controlled Drug Delivery Boca Raton: CRC Press 1998.

Lipov, E., MD. Ch. 34. Intrathecal Drug Therapy in Chronic Low Back Pain. Low Back Pain: Diagnosis and Treatament. ASIPP Publishing. Physicians. Paducah, KY. 2002.

Brunton, L., Parker, K., Blumenthal, D., Buxton, I. Goodman & Gilman’s Manual of Pharmacology and Therapeutics. McGraw-Hill 2008 New York.

Jain, K., MD. Drug Delivery Systems, Humana Press. 2008, Totowa, NJ.

Deer, T., MD. Catheter tip-associated granuloma: inflammatory mass with intrathecal drug delivery.

Markman, J., MD., Philip, A., MD. Interventional Approaches to Pain Management. Anesthesiology Clinics. Dec 2007. Volume 25, Issue 4. Saunders, An Imprint of Elsevier.

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