FORMULARIO DE CONSENTIMIENTO

INDICATIONS OF USE: ON or OFF LABEL USE only concerns marketing & promotional material for a product. Physicians are free to use any medical device for any purpose, even a use that the FDA has not approved. PRP technique is used to accelerate tissue healing and skin regeneration processes through Blood Concentrates. This proposed use is “Off-label” that is, not specifically approved by the FDA. It is important to understand that the proposed use is not experimental and if suggested by your provider, it is because it is safe and effective based on multiple clinical studies. 

There may be some variation I achieving the results requested as everyone’s body type is different and may have a different response. No guarantees or warrantees with respect to outcome or its longevity can be offered.

TREATMENT

1. You may take pain medication such as Tylenol.

2. A numbing cream is applied to the area of treatment.

3. Approximately 10 cc of whole blood is drawn from your arm.

4. The tubes of blood are centrifuged to separate the component cells. Platelets, Leukocytes and Mesenchymal stem cells are separated and used for this procedure.

5. The liquid is then transferred into a syringe and injected using a tiny needle.

ADDITIONAL PROCEDURES MAY BE NECESSARY. In some situations, it may not be possible to achieve optimal results with a single procedure and other procedures may be necessary. The practice of medicine is not an exact science. Although good results are expected, there cannot be any guarantee or warranty expressed or implied on the results that may be obtained.

PHOTOGRAPHS. Photographs are taken for clinical documentation and for scientific purposed in publications and presentations. Identity will always be protected.

FINANCIAL RESPONSIBILTIES. The cost of procedure may involve several charges for the services provided. The total may include fees charged by your doctor/practitioner, the cost of supplies, or laboratory tests if needed. Additional costs may occur should complications develop from the procedure.

Disclaimer.

Informed-consent documents are used to communicate information about the proposed surgical treatment of a disease or condition along with disclosure of risks. The informed-consent process to define principles of risk disclosure should generally meet the needs of patients in most circumstances. However, Informed-consent documents should not be considered all-inclusive in defining other methods of care and risks encountered. Your practitioner may provide you with additional or different information that is based on all the facts in your case and the state of medical knowledge. Informed-consent document are not intended to define or serve as the standard of medical care. Standards of medical care are determined based on all of the facts involved in an individual case and subject to change as science knowledge and technology advance and as practice patterns evolve. It is important that you read the above information carefully and have all your questions answered before signing the consent that follows.

I understand that no warranty or guarantee has been made to me as to result or cure. I realize that, as in all medical treatment, complications or delay in recovery may occur which could lead to the need for additional treatment and could also result in economic loss to me because of my inability to return to activity as soon as anticipated.