Sample Consent Form: Breast Reduction (Mammoplasty)

INSTRUCTIONS

This is an informed-consent document that has been prepared to help your plastic surgeon tell you about breast reduction surgery, its risks, and alternative treatments. It is important that you read this information carefully and completely. Please initial each page, indication that you have read the page and sign the consent as proposed by your plastic surgeon.

GENERAL INFORMATION

Women who have large breasts may experience a variety of problems from the weight and size of their breasts, such as back, neck, and shoulder pain, and skin irritation. Breast reduction is usually performed for relief of these symptoms and not to enhance the appearance of the breasts. The best candidates are those who are mature enough to understand the procedure and have realistic expectations about the results. There are a variety of different surgical techniques used to reduce and reshape the female breast. There are both risks and complications associated with breast reduction surgery.

ALTERNATIVE TREATMENT

Breast reduction is an elective surgical operation. Alternative treatment would consist of not undergoing the surgical procedure, physical therapy to treat pain complaints, or wearing undergarments to support large breast. In selected patients, liposuction has been used to reduce the size or large breasts. Risks and potential complications are associated with alternative surgical forms of treatment.

RISKS of BREAST REDUCTION SURGERY

Every surgical procedure involves a certain amount of risk. It is important that you understand the risks involved with breast reduction. An individual’s choice to undergo a surgical procedure is based on the comparison of the risk to potential benefit. Although the majority of women do not experience the following complications, you should discuss each of them with your plastic surgeon to make sure you understand the risks, potential complications and consequences of breast reduction.

Bleeding – It is possible, though unusual, to experience a bleeding episode during or after surgery. Should post-operative bleeding occur, it might need emergency treatment to drain accumulated blood or blood transfusion. Do not take any aspirin or anti-inflammatory medications for ten days before surgery, as this may increase the risk of bleeding.

Infection – An infection is quite unusual after this type or surgery. Should an infection occur treatment including antibiotics or more surgery may be necessary.

Change in nipple and skin sensation – You may experience a change in the sensitivity of the nipples and the skin of your breast. Permanent loss of nipple sensation can occur after a breast reduction in one or both nipples.

Skin scarring – All surgical incisions produce scarring. The quality of these scars is unpredictable. Abnormal scars may occur within the skin and deeper tissue. In some cases, scars may need surgical revision or other treatments.

Unsatisfactory result – There is the possibility of a poor result from the breast reduction surgery. You may be disappointed with the size and shape or your breasts.

Pain – A breast reduction may not improve complaints of musculoskeletal pain in the neck, back and shoulders. Abnormal scarring in skin and the deeper tissues of the breast may produce pain.

Firmness – Excessive firmness of the breast can occur after surgery due to internal scarring or fat necrosis. The occurrence of this is not predictable. If an area of fat necrosis or scarring appears, this may need biopsy or added surgical treatment.

Delayed healing – Wound disruption or delayed wound healing is possible. Some areas of the breast skin or nipple region may not heal normally and may take a long time to heal. It is even possible to have loss of skin or nipple tissue. This may need frequent dressing changes or further surgery to remove the non-healed tissue. Smokers have a greater risk of skin loss and wound healing complications.

Asymmetry – Some breast asymmetry naturally occurs in most women. Differences in breast and nipple shape, size, and symmetry may also occur after surgery. Additional surgery may be necessary to revise asymmetry after a breast reduction.

Breast disease – Breast disease and breast cancer can occur independently of breast reduction surgery. It is recommended that all women do periodic self-examination of their breasts, have mammography according to American Cancer Society guidelines, and to seek professional care should a breast lump be detected.

Breast-feeding – Although some women have been able to breast feed after breast reduction. In general this is not predictable. If you are planning to breast feed following breast reductions, it is important that you discuss this with your plastic surgeon before undergoing breast reduction.

Allergic reactions – In rare cases, local allergies to tape, suture material, or topical preparations have been reported. Systemic reactions, which are more serious, may occur to drugs used during and prescription medicines. Allergic reactions may need more treatment.

Surgical anesthesia – both local and general anesthesia involve risk. There are possibility of complications, injury, and even death from all forms of surgical anesthesia or sedation.

ADDITIONAL SURGERY NECESSARY

There are many variable conditions that may influence the long-term result of breast reduction. Secondary surgery may be necessary to do more tightening or repositioning of the breasts. Should complications occur, added surgery or other treatments may be necessary. Even though risks and complications occur infrequently, the risks cited are particularly associated with breast reduction surgery. Other risks and complications can occur but are even more uncommon. The practice of medicine and surgery is not an exact science. Although good results are expected, there is no guarantee or warranty expressed or implied, on the result that may be obtained.

HEALTH INSURANCE

Depending on your particular health insurance plan, breast reduction surgery may be considered a covered benefit. There may be other requirements in terms of the amount of breast tissue to be removed and duration of physical problems caused by large breasts. Breast reductions involving removal of small amount s of tissue may not be covered by your insurance. Please check your health insurance subscriber-information pamphlet, call your insurance company, and discuss this further with your plastic surgeon. Many insurance plans exclude coverage for secondary or revisionary surgery.

FINANCIAL RESPONSIBILITIES

The cost of surgery involves several charges for the services provided. The total includes fess charged by your doctor, the cost of surgical supplies, laboratory test, anesthesia, and outpatient hospital charges, depending on where the surgery is performed. Depending on whether the cost of surgery is covered by an insurance plan, you will be responsible for necessary co-payments, deductibles, and charges not covered. Additional costs may occur should complications develop from the surgery. Secondary surgery or hospital day surgery charges involved with revisionary surgery would be your responsibility.

ADDITIONAL ADVISORIES:

Deep Venous Thrombosis, Cardiac and Pulmonary Complications: Surgery, especially longer procedures, may be associated with the formation of, or increase in, blood clots in the venous system. Pulmonary complications may occur secondarily to blood clots (pulmonary emboli), fat deposits (fat emboli) or partial collapse of the lungs after general anesthesia. Pulmonary and fat emboli can be life threatening or fatal in some circumstances. Air travel, inactivity and other conditions may increase the incidence of blood clots travelling to the lungs causing a major blood clot that may result in death. It is important to discuss with your physician any history of blood clots or swollen legs that may contribute to this condition. Cardiac complications are a risk with any surgery and anesthesia, even in patients without symptoms. If you experience shortness of breath, chest pain or unusual heartbeats, seek medical attention immediately. Should any of these complications occur, you might require hospitalization and more treatment.

Smoking, Second-Hand Smoke Exposure, Nicotine Products (Patch, Gum, Nasal Spray): Patients who are now smoking, use tobacco products, or nicotine products (patch, gum or nasal spray) are at a greater risk for significant surgical complications of skin dying, delayed healing and added scarring. Individuals exposed to second-hand smoke are also at potential risk for similar complications attributable to nicotine exposure. Additionally, smokers may have a significant negative effect on anesthesia and recovery from anesthesia, with coughing and possibly increased bleeding. Individuals who are not exposed to tobacco smoke or nicotine-containing products have a lower risk of this type of complication. Please write your current status about these items below:

_______ I am a non-smoker and do not use nicotine products. I understand the risk of second-hand smoke
exposure causing surgical complications.

_______ I am a smoker or use tobacco/ nicotine products. I understand the risk of surgical complications due
to smoking or use of nicotine products.

It is important to refrain from smoking at least 6 weeks before surgery and until your physician states it is safe to return, if desired.

Female Patient Information: It is important to tell your plastic surgeon if you use birth control pills, estrogen replacement, or if you believe you may be pregnant. Many medications including antibiotics may neutralize the preventive effect of birth control pills, allowing for conception and pregnancy.

Intimate Relations After Surgery: Surgery involves coagulating of blood vessels and increased activity of any kind may open these vessels leading to a bleed, or hematoma. Increased activity that increased your pulse or heart rate may cause more bruising, swelling and the need for return to surgery and control of bleeding. It is wise to refrain from physical intimacy activity until your physician states it is safe.

Medications: There are many adverse reactions that occur as the result of taking over the counter, herbal, and/or prescription medications. Be sure to check with your physician about any drug interactions that may exist with medications that you are already taking. If you have an adverse reaction, stop the drugs immediately and call your plastic surgeon for further instructions. If the reaction is severe, go immediately to the nearest emergency room. When taking the prescribed pain medications after surgery, realize that they can affect your thought process. Do not drive, do not use complex equipment, do not make any important decisions and do not drink any alcohol while taking these medications. Be sure to take your prescribed medication only as directed.

PATIENT COMPLIANCE

Follow all physician instructions carefully; this is essential for the success of your outcome. It is important that the surgical incisions are not subjected to excessive force, swelling, abrasion, or motion during the time of healing. Personal and vocational activity needs to be restricted. Protective dressings and drains should not be removed unless instructed by your plastic surgeon. Successful post-operative function depends on both surgery and later care. Physical activity that increases your pulse or heart rate may cause bruising, swelling, fluid accumulation around implants and the need for the return to surgery. It is important that you take part in follow-up care, return for aftercare, and promote your recovery after surgery.

CONSENT FOR SURGERY/PROCEDURE OR TREATMENT

I hereby authorize Dr. ___________________ and such assistants as may be selected to do the following procedure or treatment:
I have received the following information sheet: INFORMED CONSENT for BREAST REDUCTION SURGERY

1 I recognize that during the course of the operation and medical treatment or anesthesia, unforeseen conditions may need different procedures than those above. I therefore authorize the above physician and assistants or designees to do such other procedures that are in the exercise of his or her professional judgment necessary and desirable. The authority granted under this paragraph shall include all conditions that need treatment and are not know to my physician when the procedure is begun.

2. I consent to the administration of such anesthetics considered necessary or advisable. I understand that all forms of anesthesia involve risk and the possibility of complications, injury, and sometimes death.

3. I acknowledge that no guarantee has been given by anyone as to the results that may be obtained.

4. I consent to the photographing or televising of the operation(s) or procedure(s) to be performed, including proper portions of my body, for medical, scientific or educational purposes, provided my identity is not revealed by the pictures.

5. For purposes of advancing medical education, I consent to the admittance of observers to the operating room.

6. I consent to the disposal of my tissue, medical devices or body parts that may be removed.

7. I authorize the release of my identity card number to proper agencies for legal reporting and medical-device registration, if applicable.

8. IT HAS BEEN EXPLAINED TO ME IN A WAY THAT I UNDERSTAND:
a. THE ABOVE TREATMENT OR PROCEDURE TO BE UNDERTAKEN
b. THERE MAY BE ALTERNATIVE PROCEDURES OR METHODS OF TREATMENT.
c. THERE ARE RISKS TO THE PROCEDURE OR TREATMENT PROPOSED I CONSENT TO THE TREATMENT OR PROCEDURE AND THE ABOVE LISTED ITEMS (1-8).

I AM SATISFIED WITH THE EXPLANATION.

__________________________________________________________________
Patient or Person Authorized to Sign for Patient/Name

Date _____________________ Witness _________________________________

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