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.
One evening in December 2001, Mary was in the hospital anticipating a hysterectomy the following morning. While lying in her hospital bed, Mary experienced what she thought was a sinus headache.
The "headache" was actually a stroke. Fibroids in Mary's uterus were generating blood clots; one reached her brain, causing a stroke. By morning, Mary had lost the use of her left arm and leg, and had paralysis on the left side of her face.
For the next 2 months Mary remained hospitalized, separated from her 12-year-old son and the church community where she's a pastor. After 6 months of intense physical therapy, Mary's left foot remained turned inward on its side. Each step was treacherous, with severe spasticity keeping her leg muscles so tight she couldn't bend at the knee or the hip.
"After all those months of therapy, my physical therapist told me the motion I'd achieved was probably as good as it was going to get," recalls Mary. "She told me to be happy with it and move on. But I couldn't leave it at that. I expected more from life, and more from myself."
Determined to reach a higher level of mobility and comfort, Mary explored other resources. She began working with a new therapist who referred her to a physician in Houston, Texas. The physician told Mary she could address the spasticity in her leg, joints, and arm, and possibly help her become more active with a Medtronic baclofen pump (ITB Therapy).
Life with ITB Therapy
ITB Therapy (Intrathecal Baclofen Therapy) relieves severe spasticity using a programmable pump placed just under the skin of the abdomen. The pump is connected to a flexible catheter that delivers a liquid form of baclofen directly into the body's intrathecal space, where fluid flows around the spinal cord.
During a screening test, a dose of liquid baclofen relieved the spasticity on Mary's left side, indicating she could be a candidate for the therapy. The pump was surgically placed in May 2003.
Mary didn't experience any 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.
Today, Mary enjoys an active life. She's a part-time pastor at her church, and participates in water aerobics and Pilates classes. Since her son graduated and went off to school, Mary moved into a townhouse with her son's golden retriever, Mover. "That means I go out dog walking a couple of times a day around the townhouse complex. For the cooler months, we have found Houston's dog parks where Mover can run, play, and swim in the dog pool while I use the people paths to walk a mile or so each time. ITB Therapy has given me independence to keep doing the things I enjoy," says Mary.
"My foot has returned to a more natural angle," she continues. "It still drags, but twisting it when I walk is no longer a concern. I feel such relief in my legs, trunk, and back."
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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.
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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.