This story recounts the experience of one individual who is receiving ITB Therapy.SM Medtronic invited her to share her story candidly. Please bear in mind that the experience is specific to this particular person. Not everyone who receives ITB Therapy will receive the same results as the patient in this story. Talk with your doctor to determine if ITB Therapy is right for you.
When Joan was 24 years old, she was living in Florida and studying to become a psychologist. Her life abruptly changed that year, when she was diagnosed with multiple sclerosis. But her real physical challenges began with the onset of her severe spasticity at age 35. Her legs started tightening up and it became more difficult for her to bend them.
Joan began treatment with oral baclofen, but quickly found that the treatment was not helping her spasticity. Her doctor suggested Medtronic ITB Therapy, also known as the baclofen pump, and explained that it relieves severe spasticity by using a programmable pump placed just under the skin of the abdomen. The pump is connected to a thin, flexible catheter that delivers a liquid form of baclofen directly into the area where fluid flows around the spinal cord, called the intrathecal space.
Joan was hesitant at first, as she did not want to undergo the operation. But, eventually, the spasticity in her left leg became so severe and uncomfortable she decided to try ITB Therapy, in 2009.
Life with ITB Therapy
In the next few weeks, Joan underwent a successful screening test and had the pump and catheter surgically placed. The spasticity in Joan's body was immediately relieved. "The tension just went out of my body, and my body relaxed. The spasticity-related pain was gone. I felt so good, so wonderful," she recalls. Although Joan had a good result during the screening test, temporary side effects can occur and may include overly loose muscles, headache, sleepiness, dizziness, and nausea/vomiting.
In addition to overall wellness, Joan states that ITB Therapy has improved her performance in physical therapy, and most importantly, it has significantly reduced the discomfort of tight muscles.
Joan didn't experience complications with her surgery. However, some people do experience surgical complications, side effects of the drug, or both. There are risks associated with ITB Therapy. Some of these risks include meningitis, spinal fluid leak, infection, paralysis, headache, swelling, bleeding, and bruising. Drug-related side effects may include loose muscles, drowsiness, nausea/vomiting, headache, and dizziness.
ITB Therapy is helping Joan release her potential. She regularly participates in art class and creates artwork for local art shows. She continues to undergo physical therapy and is able to enjoy a comfortable and active lifestyle.
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Important Safety Information – ITB Therapy
Please follow your doctor's instruction closely because a sudden stop of intrathecal baclofen therapy can result in serious illness (baclofen withdrawal symptoms) such as high fever, changed mental status, muscle rigidity, and in rare cases multiple organ-system failure and death. It is very important that your doctor be called right away if you experience any of the above symptoms.
It is important for you to keep your scheduled refill visits so you don't run out of medication (baclofen) and to understand the early symptoms of baclofen withdrawal. Some patients are at more risk than others for baclofen withdrawal; consult with your doctor.
People who suffer from severe spasticity resulting from cerebral palsy, multiple sclerosis, stroke, brain injury, or spinal cord injury may be a candidate for ITB Therapy. If you have spasticity due to spinal cord injury or multiple sclerosis you must first fail oral baclofen. If you have experienced a traumatic brain injury you must first wait 1 year after the injury to be considered for ITB Therapy. A screening test will help show if you will respond to the intrathecal baclofen. You should not receive ITB Therapy if you have an infection, are allergic to baclofen, or your body size is too small to hold the implantable pump.
The implanted pump and catheter are surgically placed beneath the skin. Surgical complications that you may experience include infection, meningitis, spinal fluid leak, paralysis, headache, swelling, bleeding, and bruising.
The most common and/or serious drug-related side effects of ITB Therapy include loose muscles, sleepiness, upset stomach, vomiting, headaches, and dizziness. Pump failure may cause overdose or underdose of intrathecal baclofen. The signs and symptoms of overdose include drowsiness, lightheadedness, dizziness, respiratory depression (difficulty breathing), hypothermia, seizures, loss of consciousness, and coma. Once the infusion system is implanted, device complications include catheter or pump moving within the body or eroding through the skin. The catheter could leak, tear, kink, or become disconnected, resulting in underdose or no baclofen infusion. Symptoms of underdose include increase or return in spasticity, itching, low blood pressure, lightheadedness, and tingling sensation. These symptoms are often early indications of baclofen withdrawal. The pump could stop because the battery has run out or because of component failure. The pump will sound an alarm when the pump needs to be filled with baclofen, replaced or if there is a problem with the pump. Always inform any healthcare personnel that you have an implanted infusion system before any medical or diagnostic procedure such as MRI or diathermy.
For more information, please read the Lioresal® Intrathecal (baclofen injection) Full Prescribing Information and the SynchroMed Infusion System Information.
This therapy is not for everyone. Please contact your doctor. A prescription is required.
Lioresal® is a registered trademark of Medtronic, Inc.
USA Rx Only Rev 0911
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.