"Emdogain implant"

About: Specialist in the Kooyong Electoral District

(as the patient),

A couple of years ago I had an Emdogain implant. I offer this personal account to help others.

My periodontist instructed me to have an ‘Emdogain’ implanted. He said it was safe. I asked about side effects, he said “none you need to be concerned about”.

I googled it. Unlike other medication, straight forward information on Emdogain side effects is near to impossible to find.

Four weeks after the procedure I began suffering various problems and continued for over 23 months. First, heat radiated in my back and ear canal. Migraines followed and my scalp and back became itchy and irritated. My eyes watery, discoloured and gritty. I suffered flu like symptoms, embarrassing uncontrolled bowl movement and sleepless nights. My scalp and back irritation became excruciating burning and stinging. GP's noted my scalp was inflamed red. Migraines so bad, one day I was hospitalised. My hair was limp and for four months began shedding more hair than usual. I also experienced breathlessness and painful sporadic impacts to the head. Half way through the following year the burning was replaced with severely itchy back and scalp. My scalp was so tender I couldn’t shower or brush my hair. For a year I took 7 codeines/ibuprofen a day. Now my stomach is sensitive and I can no longer eat anything I like. I had contacted Straumann (manufacturer), they were “baffled” by my symptoms. Straumann never gave me any information.

My peridonist totally ruled out Emdogain as the cause. He said, if you are having a reaction to Emdogain you are the only and first person and two million patients around the world have had Emdogain implants.  He suggested I had some other health problem and referred me to skin specialists and an allergist.

I spent a year seeing doctors. I had many blood, urine and skin tests and nothing was found. I was out of pocket some $2, 000. When I suggested Emdogain most GP's were silent. One GP reprimanded me and said I was imagining the symptoms (despite that in previous appointments he noted my inflamed scalp. ) He prescribed psychotic medication. The skin specialist made no diagnoses, ignored suggestions of an Emdogain reaction and prescribed Clindatech solution (side effect risks: burning, itching, diarrhoea, colitis..), EES (Erythromycin ethyl succinate) tablets (side effect risks: rash, hives, blistered skin, hearing loss…) and Nizoral shampoo (side effects: severe itching, pain, hair loss..) I binned his prescription. The Allergist ran skin tests for several allergies; the results were normal and he concluded that I may experiencing a reaction to Emdogain. To confirm, he wanted to place Emdogain in my arm. I declined. I wasn’t going to further risk my health just to prove what I suspected.

The symptoms are still present but milder. I am on the recovery.

Finally, after 19 months of internet searches I found the following, which to me confirm that my symptoms are the adverse effects of Emdogain. But you be the judge. I would like to hear from others who have had Emdogain. I am not the only and first person in the world to suffer adverse reaction to Emdogain.

From USA Food Drug and Administration 07/09/04 report:

VII ADVERSE EFFECTS OF THE DEVICE ON HEALTH

The following adverse events were observed in clinical trials for EMDOGAIN®; however, a distinction of adverse events seen due to EMDOGAIN® alone could not be performed. EMDOGAIN® is labelled for use only in conjunction with periodontal surgery; hence, inherent in this procedure are the risks associated with conventional periodontal surgery. Complications and adverse events related to the surgical procedure include the following: post-operative hemorrhage, paraesthesia and haematoma, edema, sloughing of tissue, bleeding, swelling, increased tooth mobility, hypersensitive root surfaces (root sensitivity}, pain, infection, wound dehiscence, other mucosal reactions and loosening of sutures. The adverse events observed in the clinical trials are listed below by the type of event and in the order of severity.

Local soft tissue reactions:

Local redness, inflammation, soreness, gingival irritation, haematoma/echynosis, oral candidiasis, tissue necrosis/cratering, angulitis, herpes-like blisters, hypoesthesia (burning and itching reaction on the tongue), oral mucosa reaction, fibrin layer, discoloration

Local tooth-related reactions:

Increased tooth mobility, hypersensitive root surfaces (root sensitivity), pain

General reactions:

Urticaria, itching skin reaction, gastrointestinal disturbances, urogenital disturbances

http: //www. fda. gov/ohrms/dockets/ac/04/briefing/2004-4058b1-05. pdf