Consent for intratympanic methylprednisolone perfusion

Bluegrass Ear, Nose & Throat Clinic, PSC
General Otolaryngology Allergy & Sinus Disease
205 Floyd Clay Drive, Suite #3 Winchester Kentucky 40391
: 859-745-1010 / 866-966-7468 Fax: 859-745-0080 www.bluegrassentclinic.com
CONSENT FOR INTRATYMPANIC METHYLPREDNISOLONE PERFUSION

PATIENT NAME: ______________________________________ DOB: _____/_____/_______
DATE: _____/_____/_______

Sudden sensorineural hearing loss (SSNHL) is an ear emergency in which the hearing in one ear
drops in less than 72 hours. Prompt treatment with oral prednisone can often improve the
hearing, but few patients make a full recovery. There are some indications that delivering
medicine directly into the ear rather than orally is equally effective and could have potential
advantages such as avoiding oral steroid side effects. The drug being used today is injectable
methylprednisolone, a well known anti-inflammatory steroid. Methylprednisolone is approved
by the FDA for other uses but is investigational for this procedure. Injecting steroids into the ear
has been gaining popularity in clinical practice. On the basis of your hearing tests and
examinations, and the history of your current ear problem, Dr. Makdessian has recommended
Intratympanic Methylprednisolone Perfusion/Injection.

Procedures:
You will receive two weeks of methylprednisolone injections (twice weekly
injections for a total of four doses). You will be seen one week, two weeks, two months, and six
months after the procedure. At each visit we will test your hearing.
Risks/Discomforts: Since the methylprednisolone is being injected directly through the ear
drum, it may cause local side effects such as pain, bleeding, transient dizziness, middle ear
infection, ossicle (ear bone) damage (very rare) or persistent ear drum perforation.

Benefits: There may or may not be any direct benefit to you from this treatment. The hope is that
direct injection or perfusion of the steroid in the inner ear will increase your chance of hearing
recovery. Alternative treatments are available for you and consist of standard oral prednisone or
no treatment at all. There are no alternative procedures known to benefit SSNHL at this time.
I certify that Dr. Makdessian or one of his associates has explained this procedure to me and
answered my questions. I hereby authorize Dr. Makdessian to perform upon me the following
procedure:
LEFT / RIGHT EAR INTRATYMPANIC STEROID INJECTION/PERFUSION
_________________________________________________
Patient Signature (or person authorized to consent for patient) ________________________________________________ ________________________________________________ Ara S. Makdessian, MD, FRCSC, FACS

Source: http://www.bluegrassentclinic.com/Consent%20Form-Intratympanic%20Steroid%20Perfusion.pdf

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Review and Analysis of Pfizer, Inc. v. Ranbaxy Laboratories Limited, F.3d 1284; 2006U.S. App. LEXIS 19416; 79 USPQ2d 1583 (Fed. Cir. August 2, 2006)by Richard Neifeld, Neifeld IP Law, PC, Alexandria VA1In Pfizer, Inc. v. Ranbaxy Laboratories Limited, F.3d 1284; 2006 U.S. App. LEXIS19416; 79 USPQ2d 1583 (Fed. Cir. August 2, 2006), the CAFC held patent claim 6 invalid underthe fourth paragraph o

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