THIS MEDICAL DEVICE MAY CAUSE HARM TO YOUR BABY:
It is important to talk to your doctor before using SpringTMS if you are pregnant or planning to become pregnant. There have been case reports that have looked at the safety of SpringTMS during pregnancy, but there have been no human studies on the use of SpringTMS while breastfeeding.
What is SpringTMS?
SpringTMS is a medical device that uses single pulse transcranial magnetic stimulation (sTMS). It is a portable, hand-held, low voltage device approved by the FDA in 2014. SpringTMS may be used in combination with medications. This device is currently only available by prescription from a doctor.
What is SpringTMS used to treat?
SpringTMS is used to prevent and treat acute migraine headaches with or without aura in adults. Migraine headache is characterized by episodes of pain lasting more than 2 hours, desire to be still or silent, and changing location of pain between episodes. Compared to chronic migraine, episodic migraine is characterized by fewer migraine days per month as well as decreased duration and severity of migraines.
How does SpringTMS work?
SpringTMS is a noninvasive device that is placed externally on the back of the head. The device works by sending pulses of magnetic energy that stimulate low voltage electrical impulses in the brain. Changes in the brain’s electrical field alter neurotransmitter release, which prevents hyper-excitement and “cortical spreading depression” followed by depolarization across the brain, which is thought to cause migraines, ischemic stroke, and brain hemorrhage. “Cortical spreading depression” can decrease blood flow in the brain as well as cause neuron dysfunction that is either reversible or permanently damaging.
If I am using SpringTMS, can it harm my baby?
There are limited studies available on the general safety and efficacy of SpringTMS. The manufacturer of SpringTMS states that the safety and efficacy of this device in pregnant women has not been established. There were three women in post-marketing studies who used SpringTMS for episodic or chronic migraine throughout pregnancy and reported normal labor and delivery of healthy children. Women who become pregnant or are pregnant should talk with their doctor before using SpringTMS. Patients with implantable medical devices that are susceptible to magnetic fields should avoid the use of the device; this includes valves, stents, shunts, cochealr implants, clips, coils, electrodes, and metal plates/screw/staples. Potential adverse effects associated with this device may include skin irritation, discomfort, dizziness, worsening headache, and lack of migraine relief.
If I am using SpringTMS and become pregnant, what should I do?
If you are using SpringTMS and become pregnant, you should contact your doctor immediately. Your doctor will determine if your medical device is medically necessary, or if it should be discontinued until after the birth of your baby.
If I am using SpringTMS, can I safely breastfeed my baby?
There is no available information on the safety of SpringTMS in women who are breastfeeding.
If I am using SpringTMS, will it be more difficult to get pregnant?
There have been no studies in men or women that have looked at the effects of SpringTMS on fertility.
If I am taking SpringTMS, what should I know?
The safety and efficacy of SpringTMS have not been studied in pregnant women or women who are breastfeeding. The manufacturer of SpringTMS notes a lack of available safety information on this medical device during pregnancy.
If I am taking any medication, what should I know?
This report provides a summary of available information about the use of SpringTMS during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.
You may find Pregistry's expert report about migrain headaches here, pain here, the individual medications used to treat pain here, and our reports about neurological disorders and the medications used to treat them here. Additional information can also be found in the resources below.
For more information about SpringTMS during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following links:
U.S. Food and Drug Administration: SpringTMS 510K Summary
U.S. Food and Drug Administration: SpringTMS 510K Summary (This is a different file, not a duplicate)
American Migraine Foundation: SpringTMS for Migraine Prevention