Pain pumps have become a routine part of many surgical procedures, including plastic surgery. When performing an operation that’s somewhat invasive and disruptive to internal tissues, such as abdominoplasty and breast reduction, surgeons will often finish up by attaching a temporary pain pump to ease the patient’s recovery from plastic surgery. These pumps bathe the surgical site with a continuous flow of pain medication, greatly reducing discomfort for most patients.
Now, the U.S. Food and Drug Administration has made a proactive move you should be aware of if you’re planning plastic surgery or another procedure that might involve a pump for automatic medication purposes.
These devices are termed “infusion pumps” by the FDA, as their use is wider than just as post-surgical pain medication systems. Infusion pumps also deliver insulin for diabetics, chemotherapy for cancer patients and antibiotics for people with serious infections. Noting what it describes as “numerous reports of adverse effects…including serious injuries and deaths” over a period of a few years, the FDA recently launched an “Infusion Pump Improvement Initiative.”
What’s especially notable is that normally the FDA responds to problems with medical devices on a case-by-case basis. But a large number of problems with infusion pumps during the period 2005 through 2009 prompted the FDA to take more aggressive action than usual.
During that four-year period, the agency noted 56,000 reports of “adverse events” with infusion pumps. Manufacturers issued recalls for the devices 87 times during that same time frame to address safety concerns. The majority of the recalls were deemed “Class II,” meaning that use of the device could result in temporary or reversible effects, not likely in serious health consequences. But 14 orders were “Class I” recalls, in which serious health consequences or even death could result from the use of the infusion pumps.
Many different manufacturers were involved, not just one or two.