Risk Management



Retisert™ Consent form

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>> WE STRONGLY RECOMMEND YOU ALSO SEE RETISERT RECOMMENDATIONS BEFORE USING THIS FORM

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NOTE:  THIS FORM IS INTENDED AS A SAMPLE FORM.  IT CONTAINS THE INFORMATION OMIC RECOMMENDS YOU AS THE SURGEON PERSONALLY DISCUSS WITH THE PATIENT.  PLEASE REVIEW IT AND MODIFY TO FIT YOUR ACTUAL PRACTICE.  GIVE THE PATIENT A COPY AND SEND THIS FORM TO THE HOSPITAL OR SURGERY CENTER AS VERIFICATION THAT YOU HAVE OBTAINED INFORMED CONSENT.

Version 11/29/06

 

INFORMED CONSENT FOR RetisertTM

(fluocinolone acetonide intravitreal implant)

WHAT WILL RETISERTTM DO?

Your eye surgeon (ophthalmologist) has told you that you have posterior uveitis, one of the leading causes of blindness for middle-aged people in the Western world. Posterior uveitis is a long-term condition that causes inflammation or swelling in the back of the eye that leads to vision loss.  RetisertTM has been approved by the Food and Drug Administration (FDA) to decrease the inflammation. Your eye surgeon will need to perform surgery to place the RetisertTM implant into the back of your eye. The RetisertTM implant will deliver the medication for about 30 months. Once it runs out of medication, it can be replaced if you still need it.

ALTERNATIVES

You do not have to receive this treatment for your eye condition. Without treatment, posterior uveitis can lead to further vision loss and blindness. However, other treatments for posterior uveitis are available. Such alternative treatments include other drugs to decrease inflammation which can be taken as pills, shots or drops. These treatments are not approved by the FDA for the treatment of posterior uveitis.

COMPLICATIONS FROM THE MEDICATION AND SURGERY

  • Almost all patients temporarily lose vision right away after surgery. This will last from one to four weeks. 
  • After about 8 months, most patients develop high eye pressure (glaucoma) that can cause vision loss and hurt the nerve in the eye. High eye pressure needs to be treated with eye drops. After about two years, many patients need surgery to control the pressure in their eye.
  • After about two years, almost all patients develop a cloudy lens or cataract and need to have it removed. An artificial lens is inserted, but most patients also need glasses to see well.
  • Other complications include but are not limited to infection, low eye pressure, and having parts of the eye detach. 
  • Your eye condition may not get better and may even get worse or lead to blindness even with the surgery. 
  • If you have the complications, you may need more surgery to treat them. Any of these complications, or the additional surgery, can lead to permanent vision loss or even blindness.

PATIENT RESPONSIBILITIES

I will immediately contact my ophthalmologist (eye surgeon) if I experience any signs of complications including, but not limited to, pain, blurry or decreased vision, sensitivity to light, redness of the eye, or discharge from the eye.  I will keep all post-operative appointments or scheduled telephone calls so my doctor can check for complications.            ________        Patient initials

PATIENT CONSENT

The above explanation has been read by/to me.  The nature of my eye condition has been explained to me and the proposed treatment has been described.  The risks, benefits, alternatives, and limitations of the treatment have been discussed with me.  All my questions have been answered.

I hereby authorize Dr. __________________ to implant RetisertTM (fluocinolone acetonide intravitreal implant) in my _______ (state “right” or “left”) eye. 

____________________________    ___________________

Patient’s Signature                                          Date

 

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