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Disclaimer and Acknowledgment of Understanding
By signing this consent form, you hereby acknowledge and agree that you have read, understood, and consented to all terms, conditions, and provisions set forth herein. You further acknowledge that you have had the opportunity to discuss this consent form with a licensed healthcare provider, and that any questions you have regarding this form have been answered to your satisfaction.
You expressly consent to Fella Medical Group, P.A., a Florida professional medical corporation (“Fella Medical” or “Practice”), and any of its affiliated healthcare providers, employees, agents, or contractors (collectively, “Providers”), performing any medical procedures, treatments, or services deemed necessary or advisable by your Providers in accordance with their professional judgment.
You acknowledge and agree that Fella Medical may collect, use, and disclose your personal health information (PHI) in accordance with applicable federal and state laws, including but not limited to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), for purposes of treatment, payment, or healthcare operations.
Consent to Specific Medications and Associated Risks
You understand that the medical procedures, treatments, or services performed by Fella Medical and its Providers may include, but are not limited to, the administration of compounded semaglutide injections, compounded tirzepatide injections, Testosterone Replacement Therapy (TRT), and Enclomiphene. You acknowledge and accept the following risks, side effects, and disclaimers associated with each medication:
- Compounded Semaglutide: A glucagon-like peptide-1 (GLP-1) receptor agonist administered to support weight management in conjunction with a reduced-calorie diet and increased physical activity.
- Potential Side Effects: Nausea, vomiting, diarrhea, constipation, abdominal pain, and in rare cases, pancreatitis, gallbladder disease, or renal impairment.
- Compounded Tirzepatide: A dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptor agonist used to improve glycemic control in adults with type 2 diabetes mellitus and for weight management in adults with obesity.
- Potential Side Effects: Nausea, vomiting, diarrhea, decreased appetite, abdominal discomfort, and in rare cases, pancreatitis, gallbladder disease, or an increased risk of thyroid tumors.
- Testosterone Replacement Therapy (TRT): Administered to treat symptoms of low testosterone levels in adult males, including fatigue, decreased libido, and reduced muscle mass.
- Important Consideration: TRT may lead to a significant reduction in fertility, particularly in men under 40, which may be irreversible. Patients concerned about fertility should consider sperm banking prior to initiating TRT.
- Potential Side Effects: Gynecomastia (breast tissue growth), worsening of pre-existing prostate cancer, prostate enlargement (which may cause urinary difficulties), sleep apnea exacerbation, increased red blood cell count (risking thromboembolic events), mood alterations, and acne
- Enclomiphene: A selective estrogen receptor modulator (SERM) designed to stimulate natural testosterone production in men with low testosterone levels.
- Potential Side Effects: Headaches, dizziness, nausea, mood swings, and in rare cases, visual disturbances or thromboembolic events
You acknowledge that the above-mentioned side effects do not constitute an exhaustive list, and that other side effects, both known and unknown, may occur. You agree that Fella Medical and its Providers have fully informed you of the potential risks and benefits of each treatment, as well as alternative treatment options, including but not limited to, lifestyle changes, additional prescription medications, or no treatment.
Indemnification and Limitation of Liability
To the fullest extent permitted by law, you agree to indemnify, defend, and hold harmless Fella Medical, its Providers, employees, agents, contractors, and affiliates from any and all claims, damages, losses, liabilities, costs, and expenses (including reasonable attorneys’ fees) arising out of or related to the medical procedures, treatments, or services provided to you by Fella Medical, including but not limited to, any adverse reactions, side effects, or complications associated with the use of compounded semaglutide, compounded tirzepatide, TRT, or Enclomiphene.
You understand and agree that Fella Medical, its Providers, employees, agents, contractors, and affiliates are not responsible for any injuries or damages that may result from your failure to follow the prescribed treatment plan, including but not limited to, improper medication storage, handling, or administration.
You acknowledge that Fella Medical does not guarantee the efficacy or safety of any medications and that you are assuming all risks associated with their use.
Voluntary Participation and Right to Refuse Treatment
You acknowledge that your participation in any medical procedures, treatments, or services provided by Fella Medical is entirely voluntary. You have the right to refuse any treatment or service at any time, and you acknowledge that such refusal may affect the outcomes of your medical care.
You understand that failure to adhere to the treatment plan or to attend scheduled appointments may result in suboptimal health outcomes, for which Fella Medical will not be held liable.
Confidentiality and Data Security
You understand that Fella Medical will make reasonable efforts to protect your personal health information in accordance with HIPAA and other applicable laws. However, you acknowledge that electronic communications, including telehealth services, carry inherent risks to data security, and Fella Medical cannot guarantee the absolute confidentiality of your health information in these circumstances.
Acknowledgment
You acknowledge that you should not take compounded semaglutide injections, compounded tirzepatide injections, Testosterone Replacement Therapy (TRT), or Enclomiphene if you have any contraindications specific to these treatments. This includes, but is not limited to, a personal or family history of medullary thyroid carcinoma (specifically for semaglutide or tirzepatide), or other medical conditions that may pose a risk when undergoing TRT or Enclomiphene treatment. Additionally, if you are pregnant, plan to become pregnant, or are breastfeeding, you should not take compounded semaglutide injections, compounded tirzepatide injections, or Enclomiphene. It is your responsibility to discuss any allergies, pre-existing conditions, or medical history with your doctor or pharmacist before initiating any of these treatments.
You acknowledge that alternative treatment options are available, including diet and exercise, additional prescription medications, medical procedures, and others, and that you have been informed of these alternatives.
You agree to comply with the medical program as directed by Fella Medical Group, P.A., its employees, agents, and medical providers. This includes, but is not limited to, adhering to recommended treatment plans, taking prescribed medications as directed, attending all scheduled appointments, following a prescribed diet, and complying with any other instructions provided to you. Failure to comply with the medical program may lead to suboptimal health outcomes, for which Fella Medical Group, P.A., its employees, agents, and medical providers shall not be held liable.
You are aware that Fella Medical Group, P.A., its employees, agents, and medical providers will conduct asynchronous medical check-ins via text or email as the default method of communication. You are required to attend scheduled meetings and promptly respond to communications from any personnel of Fella Medical Group, P.A. Failure to do so may delay your medical care or treatment and may result in negative health outcomes, for which Fella Medical Group, P.A. will not be responsible.
You understand and agree that Fella Medical Group, P.A., its employees, agents, and medical providers shall not be held liable for any adverse outcomes or consequences resulting from your failure to adhere to the medical program as directed. It is your sole responsibility to follow the medical program as outlined in order to receive the full benefits of the telehealth program.
You retain the right to refuse any medical procedures, treatments, or services offered by Fella Medical Group, P.A., its employees, agents, and medical providers.
You acknowledge that refusal of recommended medical procedures, treatments, or services may delay or adversely affect your medical care or treatment, and you agree that Fella Medical Group, P.A. shall not be liable for any consequences arising from such refusal.