Bocox® Consent Form

Informed Consent for the Bocox™ Procedure

I have received information about my condition, the proposed treatment, alternatives, and related risks. This form contains a summary of this information. I have received an explanation of any unfamiliar terms and have been offered the opportunity to ask questions. I have not received any promise, guarantee or warranty that my undergoing the Priapus Toxin™ procedure will achieve a particular result. I fully understand that individual results do vary and that Dr. Yam assumes no responsibility for failure to achieve a desired result. I understand I may refuse consent, and I GIVE MY INFORMED AND VOLUNTARY CONSENT to the proposed procedure and the other matters shown below. I also consent to the performance of any additional procedures determined during a procedure to be in my best interests and where delay might impair my health.

THE TREATMENT

Priapus Toxin™ procedure - Botulinum Toxin A is a neurotoxin produced by the bacterium Clostridium A. After preparation, Botulinum Toxin A is injected into the corpus cavernosi of the penis to improve penis tissue health and enhance erectile function or penis size.

1. I authorize Dr. Yam to treat my condition, including performing further diagnosis and the procedures described below, and taking any needed photographs.

2. I understand the proposed Priapus Toxin™ procedure to be: a procedure wherein Botulinum Toxin A is injected into the corpus cavernosi of the penis to improve penis tissue health and enhance erectile function or penis size.

3. I understand that the use of Botulinum Toxin A in this procedure is an “off-label” use, and no promise or representation, guarantee or warranty regarding its use, benefit or other quality is made. No representations that the use of this product for this procedure is approved by Health Canada, the FDA, or any other agency of the federal, state, or provincial government is made. Alternatives and options to the procedure have been fully explained to me.

Risks and Side Effects

4. Before undergoing this procedure, understanding the risks is essential. No procedure is completely risk-free. The following risks may occur, but there may be unforeseen risks and risks that are not included on this list.  Some of these risks, if they occur, may necessitate hospitalization and/or extended outpatient therapy to permit adequate treatment. It has been explained to me that there are certain inherent and potential risks and side effects in any invasive procedure and in this specific instance such risks include but are not limited to:

Bleeding

Infections

Urinary retention

No effect at all

Allergic reactions

Mental preoccupation of the penis

Alteration of the function of the penis

Sexual function alteration

Hematoma

Increased/worsening nocturia (waking up several times at night to urinate)

Change in urinary stream

Need for subsequent surgery

Alteration of penile sensations

Scar formation (penile)

Local tissue infarction and necrosis

Fatigue

Alteration of bladder dynamics

Post-operative pain

Prolonged pain

Intractable pain

Alteration of the male sexual response cycle

Failed procedure

Varied results

Psychological alterations

Relationship problems

Sex life alteration

Decreased sexual function

Possible hospitalization for treatment of complications

Lidocaine toxicity

Anesthesia reaction

Embolism

Depression

Reactions to medications including anaphylaxis

Nerve damage

Permanent numbness

Slow healing

Swelling

Sexual dysfunction

Allergy

Nodule formation

Post treatment discomfort, swelling, redness, and bruising;

Post treatment bacterial, and/or fungal infection requiring further treatment;

Allergic reaction: hives, itching; wheezing, difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat;

Transient headache;

Flu-like symptoms, fever, chills, body aches;

unusual or severe muscle weakness (especially in a body area that was not injected with the medication);

loss of bladder control;

hoarse voice, trouble talking or swallowing;

drooping eyelids or eyebrows;

vision changes, eye pain, severely dry or irritated eyes (your eyes may also be more sensitive to light);

chest pain or pressure, pain spreading to your jaw or shoulder, irregular heartbeats;

pain or burning when you urinate, trouble emptying your bladder;

sore throat, cough, chest tightness, shortness of breath;

eyelid swelling, crusting or drainage from your eyes, problems with vision;

painful or difficult urination;

headache, neck pain, back pain, pain in your arms or legs;

cold symptoms such as stuffy nose, sneezing, sore throat;

increased sweating in areas other than the underarms; and

bruising, bleeding, pain, redness, or swelling where the injection was given.

Similarity with Viagra 

Because botulinum toxin in the Penis works similarly to Viagra (relaxation of the smooth muscle controlling blood flow to the penis), the following side effects of Viagra could also be seen when injecting botulinum toxin into the penis - The most common adverse reactions reported in clinical trials (≥ 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash.

 The following events occurred in <2% of patients in controlled clinical trials; a causal relationship to VIAGRA is uncertain. Reported events include those with a plausible relation to drug use.

 Body as a Whole: face edema, photosensitivity reaction, shock, asthenia, pain, chills, accidental fall, abdominal pain, allergic reaction, chest pain, accidental injury.

 Cardiovascular: angina pectoris, AV block, migraine, syncope, tachycardia, palpitation, hypotension, postural hypotension, myocardial ischemia, cerebral thrombosis, cardiac arrest, heart failure, abnormal electrocardiogram, cardiomyopathy.

 Digestive: vomiting, glossitis, colitis, dysphagia, gastritis, gastroenteritis, esophagitis, stomatitis, dry mouth, liver function tests abnormal, rectal hemorrhage, gingivitis.

 Blood and Lymphatic: anemia and leukopenia.

 Metabolic and Nutritional: thirst, edema, gout, unstable diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemic reaction, hypernatremia.

 Musculoskeletal: arthritis, arthrosis, myalgia, tendon rupture, tenosynovitis, bone pain, myasthenia, synovitis.

 Nervous: ataxia, hypertonia, neuralgia, neuropathy, paresthesia, tremor, vertigo, depression, insomnia, somnolence, abnormal dreams, reflexes decreased, hypesthesia.

 Respiratory: asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, sputum increased, cough increased.

 Skin and Appendages: urticaria, herpes simplex, pruritus, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis.

 Special Senses: sudden decrease or loss of hearing, mydriasis, conjunctivitis, photophobia, tinnitus, eye pain, ear pain, eye hemorrhage, cataract, dry eyes.

 Urogenital: cystitis, nocturia, urinary frequency, breast enlargement, urinary incontinence, abnormal ejaculation, genital edema and anorgasmia.

5. I also understand that there may be other RISKS OR COMPLICATIONS, OR SERIOUS INJURY from both known and unknown causes. I am aware that the practice of medicine and surgery is not an exact science and I acknowledge that no guarantees have been made to me concerning the risks of the procedure.

ALLERGIES, NEUROLOGIC DISEASE & TOXIN INGREDIENTS

-I do not have any significant neurologic disease including but not limited to the following:

myasthenia gravis;

multiple sclerosus;

lambert-eaton syndrome;

amyotrophic lateral sclerosis (ALS, or "Lou Gehrig's disease"); or,

Parkinson’s disease.

-I have not had any of the following:

Botulinum Toxin A injections of over 100 units in the last 4 months;

side effects after prior use of Botulinum Toxin A;

breathing disorder such as asthma or emphysema;

problems with swallowing;

facial muscle weakness (droopy eyelids, weak forehead,

trouble raising my eyebrows);

change in the normal appearance of my face;

bleeding problems.

-I understand that botulinum toxin is produced by the bacterium Clostridium A. I do not have any allergies to Botulinum Toxin A (BoNT)

ALTERNATIVE PROCEDURES

Alternatives and options to the procedure have been fully explained to me.

PAYMENT

I understand that this is an "elective” procedure, and that payment is my responsibility and is expected at the time of treatment.

RIGHT TO DISCONTINUE TREATMENT

I understand that I have the right to discontinue treatment at any time.

CONSENT FOR ANESTHESIA

When the physician uses local anesthesia and/or sedation:

I consent to the administration of such local anesthetics as may be considered necessary by the physician in charge of my care. I understand that the risks of local anesthesia include the following: local discomfort, swelling, bruising, allergic reactions to medications, and seizures from lidocaine.

ELECTIVE PROCEDURE

I understand Bocox™ is an elective procedure, and I hereby voluntarily consent to treatment with Botulinum Toxin A (BoNT) injections into the penis to improve sexual function. The procedure has been fully explained to me. I also understand that any treatment performed is between me and the doctor/healthcare provider who is treating me, and I will direct all post-operative questions or concerns to the treating clinician. I have read the above and understand it. My questions have been answered satisfactorily. I accept the risks and complications of the procedure and understand that no guarantees are implied as to the procedure's outcome. I also certify that if I have any changes in my medical history, I will notify the doctor/healthcare professional who treated me immediately. I also state that I read and write in English.

I am the treating doctor/healthcare professional.  I discussed the above risks, benefits, and alternatives with the patient. The patient had an opportunity to have all questions answered and was offered a copy of this informed consent.  The patient has been told to contact my office should they have any questions or concerns after this treatment procedure.