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
General information
It is very common for women to worry about having a miscarriage or giving birth to a child with a birth defect while they are pregnant. Many decisions that women make about their health during pregnancy are made with these concerns in mind.
For many women these concerns are very real. As many as 1 in 5 pregnancies end in a miscarriage, and 1 in 33 babies are born with a birth defect. These rates are considered the background population risk, which means they do not take into consideration anything about the health of the mom, the medications she is taking, or the family history of the mom or the baby’s dad. A number of different things can increase these risks, including taking certain medications during pregnancy.
It is known that most medications, including over-the-counter medications, taken during pregnancy do get passed on to the baby. Fortunately, most medicines are not harmful to the baby and can be safely taken during pregnancy. But there are some that are known to be harmful to a baby’s normal development and growth, especially when they are taken during certain times of the pregnancy. Because of this, it is important to talk with your doctor or midwife about any medications you are taking, ideally before you even try to get pregnant.
If a doctor other than the one caring for your pregnancy recommends that you start a new medicine while you are pregnant, it is important that you let them know you are pregnant.
If you do need to take a new medication while pregnant, it is important to discuss the possible risks the medicine may pose on your pregnancy with your doctor or midwife. They can help you understand the benefits and the risks of taking the medicine.
Ultimately, the decision to start, stop, or change medications during pregnancy is up to you to make, along with input from your doctor or midwife. If you do take medications during pregnancy, be sure to keep track of all the medications you are taking.