Purpose

Using blood-derived growth factors (platelet rich fibrin matrix [PRFM]), the O-Shot® is a safe procedure for enhancing a women’s sexual pleasure and improving urinary incontinence.

Benefits

Though Platelet-Rich Plasma (PRP) comes from your own body and has demonstrated a low complication rate in other areas of the body, injecting PRP into vaginal structures and near the clitoris (the Orgasm Shot, abbreviated as the O-Shot) is a newer procedure and so could cause some unexpected side effects or complications.

Nothing contained in this consent form or in any other information provided to potential patients is intended to represent a promise, guarantee, or warranty that any patient who undergoes the Orgasm Shot™/O-Shot™ will achieve a particular result. Individual results do vary, and no responsibility is assumed for failure to achieve a desired result.

The use of PRP 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. However, the device that is approved by the FDA to prepare the PRP that’s used in the O-Shot® is approved by the FDA. No representations that the use of this product and this procedure is approved by the FDA or any other agency of the federal or state government is made.

Treatment

You may take a pain medication, such as Tylenol™ or a prescription medication may be requested. You may ask for an anti-anxiety medication to use prior to the treatment.

A numbing lidocaine cream is applied to the clitoris and anterior vaginal wall.

Approximately 15 cc (about 3.5 tablespoons) of blood are drawn in the same way blood samples are taken for routine lab tests.

The tubes of blood are centrifuged to separate the component cells. Platelets are separated and used for this procedure.

The platelets are treated with calcium chloride (which tricks the cells into thinking that they are in the body and the body has been injured). The platelets release growth factors into the liquid of the tube.

The liquid is transferred into a syringe and injected into the anterior vaginal wall “G” spot and clitoris using a tiny needle and a process is used to distribute the growth factors and increase their effectiveness.

Risks and Discomforts

The primary risks and discomforts are related to the blood draw where there is a slight pinch to insert the needle for collection and there is a potential for bruising at the site. The injections at the treatment locations cause pain like an intramuscular injection (since a small needle and numbing cream are used).

There is a potential for a small bruise at the injection sites.

There is a risk of scarring but is minimal.

Smokers have less positive response to this treatment than non-smokers.

There may be some variation in achieving the results requested as everyone’s body type is different and may have a different response.

To date, there have been no serious side effects with the use of PRP anywhere in the body. But, with or without the shot, erectile function and sensation can decrease with time. I understand that can happened and completely release Tampa Bay Total Wellness and its providers from any responsibility for any decrease in function or any other changes good or bad in relation to my penis.

Post Treatment

The post treatment therapy has been explained at the time of injection. I am acknowledging that I received instructions on post injection therapy.

Follow-up

Tampa Bay Total Wellness will follow-up with you to check on your progress and answer any questions. You may call them to report on your progress or ask questions. They can be reached at (813) 609-4150.

Consent for Anesthesia

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

CONSENT FOR PROCEDURE

The procedure as well as all stated and assumed risks and complications have been explained to me in detail. I was given time to have all my questions answered and I am consenting to proceed with the procedure 0-Shot.

Privacy

Your privacy is protected.

PHOTOGRAPHS

I authorize the taking of clinical photographs and their use for scientific purposes both in
publications and presentations. I understand my identity will be protected.

Payment

I understand this is a cosmetic procedure and that payment is my responsibility.

Your consent and authorization for this elective procedure is strictly voluntary. By signing this informed consent form, you hereby grant authorization to our medical staff to perform and/or to administer any related treatment as may be deemed necessary or advisable in the diagnosis and treatment of your condition.

The nature and purpose of this elective procedure and the complications and side effects have been fully explained to me. Alternative treatments and their risks and benefits have been explained to me and I understand that I have a right to refuse treatment. I agree to adhere to all safety precautions and instructions after the treatment. I have been instructed in and understand post treatment instructions and have been offered a written copy of them. I understand that no refunds will be given for treatments received. No guarantee has been given by anyone as to the results that may be obtained by this treatment.

I have read this informed consent and certify that I understand its contents in full. All of my questions have been answered to my satisfaction and I consent to the terms of this agreement. I have had enough time to consider the information given me and feel that I am sufficiently advised to consent to this procedure. I accept the risks and complications of the procedure. I certify if any changes occur in my medical history I will notify the office.

I hereby give my voluntary consent to this elective procedure and release the facility, medical staff, and specific technicians from liability associated with the procedure. I certify that I am a competent adult of at least 18 years of age and am not under the influence of alcohol or drugs. This consent form is freely and voluntarily executed and shall be binding upon my spouse, relatives, legal representatives, heirs, administrators, successors and assigns.

I agree, if I should have any questions or concerns regarding my treatment / results I will notify this office at immediately so that timely follow-up and intervention can be provided.