I authorize Drs.___________________________________ and whomever he/she designates as his/her assistants, the hospital, its doctors and its staff to provide for Power Morcellation for the treatment of________________________________________________.
The following information is intended to help you to more fully understand Power Morcellation and should be explained by your physician. The United States Food and Drug Administration (FDA) discourages the use of Power Morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women because it poses a risk of spreading unsuspected cancerous tissue beyond the uterus. The FDA has indicted that 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma.
The decision to attempt a Power Morcellation rests with you and your physician and must include a consideration of your medical history and a discussion of the risks of the procedure, benefits of the procedure and alternative treatment options, including the risk of non-treatment, before planning your treatment therapy.
a. Potential Benefits of Power Morcellation:
- Surgery is minimally invasive with much smaller incisions than traditional open laparotomy;
- Minimally invasive procedures generally offer improved outcomes such as a more rapid recovery, less post-operative pain, and less risk of infections and venous thromboembolism (VTE); and
- Minimally invasive procedures generally reduce the risk of adhesions or scar tissue in the pelvis.
b. Potential Risks of Power Morcellation:
- There is a risk the patient’s uterus and/or uterine fibroid(s) may contain cancer and so the use of Power Morcellation in such patients will increase the chance that the cancer will spread beyond the uterus;
- If unsuspected cancer is present, this may worsen the patient’s prognosis as well as contribute to the need for additional cancer therapy, including but not limited to chemotherapy, radiation, and surgical intervention;
- The spread of cancer also significantly increases the patient’s risk of death; and/or
- There is a risk that small pieces of tissue will be left inside the abdominal cavity and may attach to bowel, pelvic walls and organs which may result in further fibroid growth, pelvic pain, bowel obstruction and additional surgery to remove the fibroids.
The nature and purpose of the Power Morcellation, risks involved, and the possibility of complications have been explained to me. Possible alternative methods of treatment, including the risk of non-treatment have also been explained to me. I have had an opportunity to discuss Power Morcellation with the physician and other doctors concerned, and I have received answers to all questions I asked and do hereby assume all risks involved. No guarantee or assurance has been given to me by anyone as to the results that may be obtained.
I have read and fully understand this consent to Power Morcellation. I acknowledge that the explanations above were made. The physicians have answered all my questions and I consent to the use of Power Morcellation as noted above.
Date: ________ Time:________ Signed:_________________________________________
Patient/Legally Authorized Representative
Date: ________ Time:________ Signed:_________________________________________
Witness
CERTIFICATION OF INTERPRETATION
I certify that I have read the foregoing to the signer here of in___________________________ language.
Date: ________ Time:________ Signed:_________________________________________
Interpreter
PHYSICIAN AFFIRMATION / DECLARATION
I have discussed the nature, purpose and risks of Power Morcellation, alternative methods of treatment and the possibility of complications with the patient and/or the patient’s authorized representative. I have given the opportunity to ask questions and have answered any such questions.
Date: ________ Time:________ Signed:_________________________________________
Physician