Pain Pump Adverse Events Extend Far Beyond Shoulder Surgeries
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The controversy and litigation over local anesthetic infusion pumps—pain pumps—has to date largely been focused on shoulder surgeries and chondrolysis. There is a perception that these devices were intended by their manufacturers for use primarily in the shoulder. I have seen some complaints and discovery documents from plaintiffs lawyers even refer to these devices as “shoulder pain pumps.”
In fact, these devices have been and continue to be routinely used in surgeries throughout the body. What hasn’t received sufficient attention is the fact that numerous adverse events involving types of surgery other than to the shoulder have been reported for many years, including prior to the problem of chondrolysis in the shoulder being identified with these devices.
In 2004, two FDA researchers published a journal article, Local Anesthetic Infusion Pump Systems Adverse Events Reported to the Food and Drug Administration. They summarized 40 injuries reported to the FDA that followed the use of pain pumps at a variety of surgical sites including orthopedic, gastrointestinal, and podiatric. The complications encountered with the pain pumps included tissue necrosis, surgical wound infection, and cellulitis. 45% of the surgeries were orthopedic, typically total knee replacements. 20% were for podiatric surgeries, including bunionectomies, plantar fasciotiomies, and others.
All of the reports that specified the local anesthetic involved Bupivacaine (most common trade name—Marcaine) with or without adrenaline. The consequences of these adverse events were typically severe and required intervention and additional medical and surgical treatment. The authors’ review of the literature found little had been written to support a causal link between pain pumps and the complications that had been reported to the FDA. Therefore, the authors’ conclusion was tentative and stated the reports may represent sentinel events, i.e., an early warning that is representative of a widespread problem, or alternatively, these may be isolated incidents.
The FDA Medical Device adverse event database shows that at least 60 additional adverse events involving tissue necrosis and other wound-healing complications and pain pumps manufactured by I-Flow Corporation (the largest manufacturer of pain pumps) alone have been reported to the FDA since December 2003, the end-point of the article’s scope. It seems likely these events are not isolated and indicate a serious problem with these devices, beyond their likely relationship to chondrolysis in shoulder surgeries. There is a substantial body of evidence that Bupivacaine, even without epinephrine, causes severe damage to a variety of human tissue including muscle, subcutaneous skin, as well as cartilage.
Prior to the advent of pain pumps, local anesthetics were typically used in relatively small amounts to provide nerve blocks or in the margins of surgical wounds to provide pain relief. Even if harm to tissues occurred it likely went unnoticed because cells damaged by local anesthetics typically regenerate and surgical pain and dressings may have masked such harm. Pain pumps infuse much larger volumes of these drugs, which appears to be especially problematic in certain areas of the body such as joint spaces--shoulder and knee--and the foot.
I believe pain pump manufacturers have improperly relied on the dose and concentration recommendations made by the makers of Bupivacaine for past uses, without adequate research to support its safe use when continuously infused in larger volumes. Even when pain pump manufacturers have been confronted with evidence of adverse events involving their products, they have failed to adequately warn surgeons and the public of these risks. It is likely that hundreds of patients, if not more, have suffered injuries, many life-altering, as a result.
