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September 08, 2013

Lawsuit Alleges Transcranial Magnetic Stimulation Paralyzed Patient's Face

University of Iowa Hospitals and Clinics is being sued by a patient who underwent an experimental transcranial magnetic stimulation (TMS) therapy which allegedly caused a facial paralysis which was than negligently treated. The trial is scheduled for Oct 13, 2013. [link]

Briefly, the patient in 2008 underwent experimental TMS to treat constipation and incontinence. TMS is a noninvasive method to cause depolarization or hyperpolarization in the neurons of the brain using pulses of electromagnetic induction through the scalp. Researchers were hoping to learn more about the nerve connections between the brain and the rectum and how biofeedback training may affect them.

Unfortunately, the patient contended that the treatment gave her a severe headache and by the next day, a facial paralysis. She went to the emergency room and was given an anti-viral antibiotic to take, but no steroids.

Her facial paralysis worsened and she ultimately underwent facial nerve decompression surgery 12 days later which helped with her taste loss, but not her facial paralysis.

The lawsuit contends that:
1) The patient was not informed of the risks of TMS as it relates to facial paralysis
2) Steroids should have been prescribed and the patient immediately referred for nerve decompression surgery

Does TMS carry a risk of facial paralysis?

I honestly do not know much about TMS, but I can certainly state that I've never heard of TMS causing or carrying a risk of facial paralysis. In fact, TMS is used to evaluate facial paralysis by being able to assess the integrity of the facial nerve as well as predict its potential for regeneration after injury [link].

Hypothetically, could TMS cause cranial nerve injury and swelling leading to facial paralysis??? I suppose so, but will defer to people more knowledgeable than I to answer this question.

The timing is certainly suspicious in this case with paralysis occurring within 24 hours of TMS.

But if it can, it certainly is worth a published case report.

Even more importantly, patients who are currently undergoing TMS to evaluate their facial paralysis now need to be warned of the risk that the TMS test itself may make their facial paralysis even worse!!!

What about steroids?

Although some may consider medical management of facial paralysis still controversial, I personally feel that steroids SHOULD have been immediately prescribed without any anti-virals.

The current preponderance of evidence is that anti-virals make absolutely no difference in the treatment of facial paralysis... even when the facial paralysis is due to a virus [link].  I personally do not prescribe anti-virals for patients with facial paralysis regardless of etiology.

What about steroids? Moderate quality evidence show that steroids were significantly more likely than anti-virals to produce complete recovery [link #1; link #2]. I always prescribe steroids to treat facial paralysis.

What about facial nerve decompression surgery?

Now surgical decompression of the facial nerve can be considered controversial. Decompression entails removing part of the skull, moving the brain to one side slightly, and removing all bone covering the facial nerve.

The theory being that if the facial nerve is swollen as it courses through the skull from the brain to the face, strangulation followed by nerve death occurs. To use an analogy, if a finger starts to swell from trauma, a ring being worn may prevent blood flow and eventually cause strangulation of the finger. Treatment to reestablish finger blood flow is to cut the ring off. Facial nerve decompression is akin to cutting a ring off to save a swollen finger.

Typically, surgical decompression of the facial nerve is pursued when facial paralysis occurs in the context of physical head trauma (ie, car accident). In the absence of preceding physical trauma, it would be the rare surgeon who would recommend surgical facial nerve decompression.

Obviously, the main question related to this lawsuit is whether nerve swelling occurred due to the TMS therapy necessitating surgical decompression. Presumably, an MRI scan was performed showing a highly inflamed and swollen facial nerve as well as significant nerve degeneration on ENoG testing. Supporting evidence (not mentioned in media reports) would be if profound hearing loss also occurred. Why? Because the facial nerve and hearing nerve both go through the same boney canal.

Malpractice?

TMS is not known to cause facial paralysis. As such, in a normal situation, this particular risk would not be expected to be included in the consent (as it has not been previously described). However, given this therapy was provided in the context of an experimental research protocol, the consent process is much more rigorous with much higher standards. With such higher standards, should risks never before seen be also included in the consent, especially if TMS has been performed many times for other purposes??? I don't know...

Certainly, my feeling as an ENT specialist is that steroids should have been given and not an anti-viral medication. Whether ENT specialist standards should apply to emergency room staff is harder to say.

Without more information, negligence as it pertains to delayed surgical facial nerve decompression is also hard to say.

Ultimately, we shall see what the court decides.


Source:
Lawsuit alleges Iowa doctors left patient's face paralyzed. Associated Press 8/13/13

References:
Transcranial magnetic therapy. Wikipedia

Electrical and transcranial magnetic stimulation of the facial nerve: diagnostic relevance in acute isolated facial nerve palsy. Eur Neurol. 2012;68(5):304-9. doi: 10.1159/000341624.

Antiviral therapy for Ramsay Hunt syndrome (herpes zoster oticus with facial palsy) in adults. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006851. doi: 10.1002/14651858.CD006851.pub2.

Antiviral treatment for Bell's palsy (idiopathic facial paralysis). Cochrane Database Syst Rev. 2009 Oct 7;(4):CD001869. doi: 10.1002/14651858.CD001869.pub4.

Do either corticosteroids or antiviral agents reduce the risk of long-term facial paresis in patients with new-onset Bell's palsy? J Emerg Med. 2010 May;38(4):518-23. doi: 10.1016/j.jemermed.2009.08.016. Epub 2009 Oct 21.
Fauquier blog
Fauquier ENT

Dr. Christopher Chang is a private practice otolaryngology, head & neck surgeon specializing in the treatment of problems related to the ear, nose, and throat. Located in Warrenton, VA about 45 minutes west of Washington DC, he also provides inhalant allergy testing/treatment, hearing tests, and dispenses hearing aids. Google+ Christopher Chang, MD Bio

2 comments:

  1. In patients that have more than 90% degeneration on electroneurography (ENOG), decompression has been shown to improve outcomes. It has only been shown to improve outcomes if performed in the first two weeks from onset of facial paralysis. There are several problems.

    1. Most places do not routinely get ENOGs to determine the severity of the injury.
    2. Patients often present outside of the two week window when the surgery would be beneficial
    3. The surgery improves the chance of some facial nerve function return. If it is severe enough to decompress, it is a pretty severe trauma to the nerve and unlikely that patient will get full return of nerve function. It also will likely take several months before final outcome presents itself.
    4. The number of cases of facial paralysis with an ENOG showing

    This occurred at the University of Iowa where Dr. Bruce Gantz is the chairman of Otolaryngology. He is the author of the study that demonstrated the benefit of facial nerve decompression in when there is greater than 90% degeneration on ENOG. It took him years to accrue enough patients to prove his theory which was published in 1999.

    Laryngoscope. 1999 Aug;109(8):1177-88. Surgical management of Bell's palsy. Gantz BJ, Rubinstein JT, Gidley P, Woodworth GG.

    I am sure that she had greater than 90% degeneration on ENOG because Dr. Gantz, or Dr. Hansen, the neurootologist at the University of Iowa, would not have operated unless that was the case.

    Outside of an academic center, I have found it difficult to find out where to send a patient for an ENOG, so often will send to a neurootologist who is capable of performing this test.

    I agree with your post about the steroids and the antivirals. No studies have shown benefit with antivirals. I routinely place patients on steroids if they present within the two week window from onset of complete paralysis. Usually treat patients with higher dose of steroids than ER's or PCP's are willing to start. Usually they need more than a medrol dosepack.

    One other point is that is often forgotten in cases of Bell's Palsy is that it is a diagnosis of exclusion. I would imagine that every otolaryngologist has seen those patients that were labeled as having Bells Palsy without any workup, only to find an invasive parotid tumor or other diagnosis that was causing the facial paralysis.

    ReplyDelete
    Replies
    1. Thanks for your great response and input pertaining to surgical decompression. Not many communities have ENoG testing as you have stated... but also lack nearby otologic surgeon to perform nerve decompression since the vast majority of general ENT's would certainly not be comfortable performing this type of operation.

      Delete

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