“Pain pumps” may be prescribed for patients with severe chronic pain. Intrathecal pumps are an alternative method of taking pain medication available to patients who have trouble getting relief from the traditional pain management techniques. However, there may be a number of intrathecal pain pump side effects.
About Intrathecal Pain Pumps
First introduced in the 1940s, intrathecal medication began primarily as a way to treat pain in cancer patients by surgically inserting a catheter into the spine to inject medicine directly into the cerebrospinal fluid. This process was refined to be less intrusive in the 1970s, and by the 1990s intrathecal pain pumps were battery powered and programmable to the patient’s specific needs.
By using a pain pump, medications such as morphine are administered in smaller doses with similar effectiveness.
Eligibility and Frequency of Intrathecal Pump Use
Intrathecal pumps are not a go-to solution for pain relief. The surgical precision and intensity of injecting medication into the cerebrospinal fluid make an intrathecal pump more of a last-resort measure for managing severe pain.
Most users of intrathecal pumps are those who have suffered severe side effects from oral, intravenous, and transdermal (skin patches) methods of pain relief or those for whom relief can’t be achieved with even a high dosage of opioids. Patients will need to return for frequent refills of medications and check-ups to ensure that the catheter has not moved or become less effective. Additionally means that the patient must be psychologically evaluated to determine whether they are willing or capable of making this commitment. Often patients must have a dire condition with immense pain to qualify for intrathecal pump implantation.
Potential Intrathecal Pain Pump Side Effects
Though intrathecal pumps are highly effective and life-extending tools, they are not without their fair share of risks. As with any surgery, there is the risk of infection or bleeding that can occur as a result of poor healing or poor sanitization post-op. Additionally, since the catheter is inserted into the spine, there is the risk of loss of bowel or bladder control, paralysis, or infection of the spinal cord. Complications following the surgery could include a catheter leak, tear, or kink over time. Pumps can stop unexpectedly, or lose effectiveness due to catheter disconnection. There is also the risk of the catheter or pump moving within the body or wearing through the skin through the course of daily life.
YourLawyer Investigating Intrathecal Pain Pumps
YourLawyer is investigating into the potential risks and damages that are occurring in the course of these operations to protect consumers and make sure that surgeons and manufacturers are continuing to maintain best practices in their line of work.
What are Intrathecal Pumps?
Intrathecal pain pumps are surgically implanted electronic devices that administer doses of anesthetic drugs to manage pain in patients with severe chronic pain, often due to cancer or other dire medical conditions. By making a small incision in the lower back, typically the lumbar region, a programmable catheter is inserted into the intrathecal space between spinal bones to deliver pain medication directly into the cerebrospinal fluid which travels between the spine and the brain.
By injecting medication directly into the cerebrospinal fluid instead of taking the drug orally, patients can mitigate many of the side effects of the oral medicine and can experience the same level of relief from a much smaller dosage. In fact, according to Mayfield Clinic, intrathecal injection requires only 1/300 the amount of medication to receive the same amount of pain management in most patients. Intrathecal pumps have improved the lives of many people for nearly 80 years, allowing them to live and die free of pain. Unfortunately, this procedure can also have many dangerous repercussions.
An Overview of Intrathecal Pumps
Intrathecal pumps are a serious commitment of both time and resources. Patients will require refills of their medication and follow-up treatment to ensure normality for the duration that the pump is implanted. Many patients who receive an intrathecal pump have a severe illness or injury such as:
- Failed back surgery
- Severe nerve pain
- Cerebral palsy
- Multiple sclerosis
- Brain/Spinal cord injury
Only these or other dangerous conditions warrant the implantation of an intrathecal pump and only after most other alternative methods of pain relief have failed. Intrathecal pumps are also only available for a limited amount of medications. The U.S. Food and Drug Administration (FDA) has exclusively approved the use of three drugs (morphine, ziconotide, and baclofen) for intrathecal distribution.
Despite the innovative strides made, intrathecal pumps aren’t foolproof. Over and underdoses are possible and have resulted in the need for recalls due to fatal faults. In May 2013, the FDA recalled an intrathecal pump produced by Medtronic after it was shown to have caused 14 fatalities.
Medical Studies on Intrathecal Pumps
Due to the sensitive nature of intrathecal pumps, many studies have been conducted to audit the safety and security of the systems in place and how they might be strengthened or improved.
In 1998, The Journal of the American Society of Anesthesiologists published a report that detailed the death of users of intrathecal pumps from accidents refilling the pump. This study also included case studies of patients found using the intrathecal system to administer opiates and methamphetamine directly into the cerebrospinal fluid. These patients had not previously shown tendencies of addiction and had passed their mandatory psychological evaluations.
In 2007, The Croatian Medical Journal published a study reviewing the proper procedures and practices regarding Intrathecal pumps, including the ethicality of installing pain pumps into patients whose prognosis falls under three months. The study also DIscuss the risk of cerebrospinal fluid leakage, which they cite is as high as 20%, and follow-up surgeries to correct this and prevent the formation of other complications such as hygromas.
In 2008, Pain Medicine published an article detailing the complications of intrathecal pump use and implantation over time. Spinal cord injury, nerve injury, and cauda equine injury were mentioned as direct trauma to the spinal cord or nerve root, as well as other, less common, risks such as a “pump dump” in which the entire reservoir, sometimes several months worth of medication, is administered at once resulting in a catastrophic overdose. If a pump is disconnected, it could result in withdrawal-like symptoms, and a mistake in refilling the pump could result in the refill being applied to the spine itself or surrounding tissue, again resulting in a massive overdose.
Intrathecal Pain Pump FDA Regulations
The FDA has also been adamantly maintaining watch over the various intrathecal pumps hitting the market, issuing recalls and warnings. One example of this occurred in 2013 when the FDA issued a class I recall for Medtronic’s line of intrathecal pumps following reports of over a dozen deaths from overdoses.
On November 14, 2018, The FDA announced that several medications are being prescribed for use in intrathecal pain pumps that the FDA itself has not approved. In their safety communication, the FDA has published some examples of these severe wrongdoings including “ [using] medicines not FDA approved for intrathecal administration or intrathecal implanted pump use (for example, hydromorphone, bupivacaine, fentanyl, clonidine) . . . [using] ANY [sic] mixture of two or more different kinds of medicines . . . [using] Any compounded medicine (for example, to achieve higher concentration or different formulation of an FDA approved medicine).” According to the FDA, this disregard for regulation has resulted in pump malfunctions and dosing errors that could have fatal repercussions for patients using intrathecal pumps.
Filing An Intrathecal Pain Pumps Lawsuit
If you or a loved one has experienced paralysis, infection, overdose, shortened lifespan, or sudden death because of careless or ignorant actions of doctors, legal remuneration may be available to right those wrongs.
Parker Waichman LLP., can help ease the burden of these malpractices through expert litigation to hold the parties responsible for these complications responsible in a court of law.