This informed-consent document has been prepared to help inform you about nipple reconstruction surgery, its risks, and alternative treatment(s).
It is important that you read this information carefully and completely. Please initial each page, indicating that you have read the page, and sign the consent for surgery as proposed by your plastic surgeon and agreed upon by you.
Nipple reconstruction involves the restoration of the nipple-areolar complex lost due to injury, breast cancer or other conditions. A variety of different techniques exist for reconstruction of the nipple and its surrounding areolar tissue. These include the use of skin grafts taken from other regions of the body, local flaps of breast skin that are shaped into a nipple, or the sharing of tissue from the opposite nipple-areolar region. Additional techniques such as tattooing may be used to add color to the tissue if needed.
Nipple reconstruction may be performed as a single surgical procedure, or combined with other breast reconstruction procedures.
Nipple reconstruction surgery is an elective surgical operation. Alternative treatment would consist of not undergoing the surgical procedure or the use of external nipple-areolar prostheses.
RISKS OF NIPPLE RECONSTRUCTION SURGERY
Every surgical procedure involves a certain amount of risk and it is important that you understand these risks and the possible complications associated with them. In addition, every procedure has limitations. An individual’s choice to undergo a surgical procedure is based on the comparison of the risk to potential benefit. Although the majority of patients do not experience these complications, you should discuss each of them with your plastic surgeon to make sure you completely understand all possible consequences of nipple reconstruction surgery.
Bleeding- It is possible, though unusual, to experience a bleeding episode during or after surgery. Should post-operative bleeding occur, it may require emergency treatment to drain accumulated blood (hematoma) or blood transfusion. Intra-operative blood transfusion may also be required. Do not take any aspirin or anti-inflammatory medications for ten days before or after surgery, as this may increase the risk of bleeding. Non-prescription “herbs” and dietary supplements can increase the risk of surgical bleeding. Hematoma can occur at any time following injury to the breast. If blood transfusions are necessary to treat blood loss, there is the risk of blood-related infections such as hepatitis and HIV (AIDS). Heparin medications that are used to prevent blood clots in veins can produce bleeding and decreased blood platelets.
Infection- Infection is unusual after this type of surgery. If an infection occurs, additional treatment including antibiotics, hospitalization, or additional surgery may be necessary. It is possible that skin graft loss or nipple loss may occur from an infection following nipple reconstruction surgery.
Scarring- All surgery leaves scars, some more visible than others. Although good wound healing after a surgical procedure is expected, abnormal scars may occur within the skin and deeper tissues. Scars may occur in both the nipple reconstruction site and the donor site for tissues used in the nipple reconstruction. Scars may be unattractive and of different color than the surrounding skin tone. Scar appearance may also vary within the same scar. Scars may be asymmetrical (appear different on the right and left side of the body). There is the possibility of visible marks in the skin from sutures. In some cases, scars may require surgical revision or treatment.
Skin Grafts- Skin grafts are used in some nipple reconstruction techniques. The location of where the graft is taken may have residual scarring, poor healing, or abnormal color. Chronic itching sensations have been reported. Skin graft loss can occur due to infection or other causes. Additional skin grafts may be needed.
Hair Growth- Skin grafts used in nipple reconstruction may contain hair follicles. Unattractive hair growth may occur in the reconstructed nipple. Additional treatment may be required to remove the hair follicles.
Tattoos- If tattooing is required as an additional procedure, it may be impossible to precisely match the color and texture of the opposite nipple-areolar complex.
Change in Nipple Sensation- Nipple reconstruction cannot restore normal sensation to the breast or nipple.
Skin Contour Irregularities- Contour and shape irregularities may occur. Nipple position and shape will not be identical one side to the next. Residual skin irregularities at the ends of the incisions or “dog ears” are always a possibility when there is excessive redundant skin. This may improve with time, or it can be surgically corrected.
Sutures- Most surgical techniques use deep sutures. You may notice these sutures after your surgery. Sutures may spontaneously poke through the skin, become visible or produce irritation that requires suture removal.
Skin Discoloration / Swelling- Some bruising and swelling normally occurs following a nipple reconstruction. The skin in or near the surgical site can appear either lighter or darker than surrounding skin. Although uncommon, swelling and skin discoloration may persist for long periods of time and, in rare situations, may be permanent. Additionally, these areas may have exaggerated responses to hot or cold temperatures.
Allergic Reactions- In rare cases, local allergies to tape, suture material and glues, blood products, topical preparations or injected agents have been reported. Serious systemic reactions including shock (anaphylaxis) may occur to drugs used during surgery and prescription medications. Allergic reactions may require additional treatment.
Delayed Healing- Wound disruption or delayed wound healing is possible in either the site of nipple-areolar reconstruction or donor location(s) for tissue. Some areas of the nipple reconstruction or tissue donor sites may heal abnormally or slowly. Some areas of skin may die, requiring frequent dressing changes or further surgery to remove the non-living tissue. Individuals who have decreased blood supply to breast tissue from past surgery or radiation therapy may be at increased risk for delayed wound healing and poor surgical outcome. Smokers have a greater risk of skin loss and wound healing complications.
Surgical Anesthesia- Both local and general anesthesia involve risk. There is the possibility of complications, injury, and even death from all forms of surgical anesthesia or sedation.
Damage to Deeper Structures- There is the potential for injury to deeper structures including nerves, blood vessels, muscles, and lungs (pneumothorax) during any surgical procedure. The potential for this to occur varies according to the type of procedure being performed. Injury to deeper structures may be temporary or permanent.
Fat Necrosis- Fatty tissue found deep in the skin might die. This may produce areas of firmness within the skin. Additional surgery to remove areas of fat necrosis may be necessary (breast biopsy). There is the possibility of contour irregularities in the skin that may result from fat necrosis.
Seroma- Fluid accumulations infrequently occur between the skin and the underlying tissues. Should this problem occur, it might require additional procedures for drainage of the fluid.
Breast Implant Damage- Breast implant damage can occur during a nipple reconstruction surgery. A damaged or broken implant will require surgery for replacement or removal.
Asymmetry- Some breast asymmetry naturally occurs in most women. Differences in breast and nipple shape, size, or symmetry may also occur after surgery. Additional surgery may be necessary to attempt to correct asymmetry.
Damage to Opposite Nipple- Some nipple reconstruction procedures use a tissue-borrowing technique from the opposite nipple region. It is possible that the donor nipple region may be damaged or lose normal sensation.
Pain- You will experience pain after your surgery. Pain of varying intensity and duration may occur and persist after nipple reconstruction surgery. Chronic pain may occur very infrequently from nerves becoming trapped in scar tissue after nipple reconstruction.
Shock- In rare circumstances, your surgical procedure can cause severe trauma, particularly when multiple or extensive procedures are performed. Although serious complications are infrequent, infections or excessive fluid loss can lead to severe illness and even death. If surgical shock occurs, hospitalization and additional treatment would be necessary.
Unsatisfactory Result- Although good results are expected, there is no guarantee or warranty expressed or implied, on the results that may be obtained. You may be disappointed with the results nipple reconstruction surgery. Asymmetry in nipple placement, shape, projection, and appearance may occur after surgery. Unsatisfactory nipple placement may occur. It may not be possible to precisely match the opposite nipple areolar complex. Other risks include unsatisfactory or highly visible surgical scar location, unacceptable visible deformities, bunching and rippling in the skin near the suture lines or at the ends of the incisions (dog ears), poor healing, wound disruption, and loss of sensation. It may not be possible to correct or improve the effects of surgical scars. Nipple reconstruction may fail due to complications attributable to the surgery or from chemotherapy/radiation therapy treatments that are independent of the procedure. Additional surgery may be required to improve results.
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 both blood clots (pulmonary emboli), fat deposits (fat emboli) or partial collapse of the lungs after general anesthesia. Pulmonary emboli can be life threatening or fatal in some circumstances. Inactivity and other conditions may increase the incidence of blood clots traveling to the lungs causing a major blood clot that may result in death. It is important to discuss with your physician any past 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 pains, or unusual heart beats, seek medical attention immediately. Should any of these complications occur, you may require hospitalization and additional treatment.
Breast Disease- Current medical information does not demonstrate an increased risk of breast disease, breast cancer, or recurrence of breast cancer in women who have had reconstructive breast surgery. Breast disease and breast cancer can occur independently of breast surgery. Individuals with a personal history or family history of breast cancer may be at a higher risk of developing breast cancer than a woman with no family history of this disease. It is recommended that all women perform regular self-examination of their breasts, have mammograms according to American Cancer Society guidelines, and seek professional care should a breast lump be detected.
Long-Term Results- Subsequent alterations in the shape, size, color, and prominence of the reconstructed nipple-areolar complex may occur as the result of aging, sun exposure, weight loss, weight gain, pregnancy, menopause, or other circumstances not related to your surgery.
Pregnancy and Breast Feeding- If a woman has undergone a mastectomy, it is unlikely that she would be able to breast feed a baby on the affected side. Reconstructed nipples cannot be used for breast feeding.
Breast and Nipple Piercing Procedures- Individuals who currently wear body-piercing jewelry in the breast region are advised that a breast infection could develop from this activity.
Female Patient Information- It is important to inform your plastic surgeon if you use birth control pills, estrogen replacement, or if you suspect 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 additional bruising, swelling, and the need for return to surgery and control of bleeding. It is wise to refrain from sexual activity until your physician states it is safe.
Smoking, Second-Hand Smoke Exposure, Nicotine Products (Patch, Gum, Nasal Spray)-
Patients who are currently 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 additional scarring. Individuals exposed to second-hand smoke are also at potential risk for similar complications attributable to nicotine exposure. Additionally, smoking 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 significantly lower risk of this type of complication. Please indicate your current status regarding 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.
Medications- There are potential 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 which 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 and coordination. Do not drive, do not operate 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.
Mental Health Disorders and Elective Surgery- It is important that all patients seeking to undergo elective surgery have realistic expectations that focus on improvement rather than perfection. Complications or less than satisfactory results are sometimes unavoidable, may require additional surgery and often are stressful. Please openly discuss with your surgeon, prior to surgery, any history that you may have of significant emotional depression or mental health disorders. Although many individuals may benefit psychologically from the results of elective surgery, effects on mental health cannot be accurately predicted.
ADDITIONAL SURGERY NECESSARY
Should complications occur, additional surgery or other treatments may be necessary. Secondary surgery may be necessary to obtain optimal results. Even though risks and complications occur infrequently, the risks cited are particularly associated with nipple reconstruction surgery. Other complications and risks 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 results that may be obtained. In some situations, it may not be possible to achieve optimal results with a single surgical procedure.
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 subsequent care. Physical activity that increases your pulse or heart rate may cause bruising, swelling, fluid accumulation and the need for return to surgery. It is wise to refrain from intimate physical activities after surgery until your physician states it is safe. It is important that you participate in follow-up care, return for aftercare, and promote your recovery after surgery.
Most insurance carriers consider nipple reconstruction surgery a covered benefit. There may be additional requirements. Please review your health insurance subscriber-information pamphlet, call your insurance company, and discuss this further with your plastic surgeon. Most insurance plans exclude coverage for secondary or revisionary surgery.
The cost of surgery involves several charges for the services provided. The total includes fees charged by your surgeon, the cost of surgical supplies, anesthesia, laboratory tests, and possible 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. The fees charged for this procedure do not include any potential future costs for additional procedures that you elect to have or require in order to revise, optimize, or complete your outcome. Additional costs may occur should complications develop from the surgery. Secondary surgery or hospital day-surgery charges involved with revision surgery will also be your responsibility. In signing the consent for this surgery/procedure, you acknowledge that your have been informed about its risk and consequences and accept responsibility for the clinical decisions that were made along with the financial costs of all future treatments.
Informed-consent documents are used to communicate information about the proposed surgical treatment of a disease or condition along with disclosure of risks and alternative forms of treatment(s), including no surgery. The informed-consent process attempts to define principles of risk disclosure that should generally meet the needs of most patients in most circumstances.
However, informed-consent documents should not be considered all inclusive in defining other methods of care and risks encountered. Your plastic surgeon may provide you with additional or different information which is based on all the facts in your particular case and the current state of medical knowledge. Informed-consent documents are not intended to define or serve as the standard of medical care. Standards of medical care are determined on the basis of all of the facts involved in an individual case and are subject to change as scientific knowledge and technology advance and as practice patterns evolve.
It is important that you read the above information carefully and have all of your questions answered before signing the consent on the next page.
CONSENT FOR SURGERY / PROCEDURE or TREATMENT
1. I hereby authorize Boris Volshteyn MD and associates and assistants of his choice at the Hospital, his office, or Ambulatory Surgery Center to perform the following operations, procedures or treatments
NIPPLE RECONSTRUCTION SURGERY, POSSSIBLE SKIN GRAFT, FLAP, or BREAST REVISION
2. Dr. Boris Volshteyn, or one of his associates fully explained to me the nature and purposes of the procedure and has also informed me of expected benefits and complications (from known and unknown causes), attendant discomforts and risks that may arise, as well as possible alternatives to the proposed treatment and I willingly assume them. Also, probable duration of incapacitation, potential problems related to recuperation, if any, and medically significant alternative methods of care have been explained to me before making this decision.
3. I was counseled on appropriate risks, complications, and alternatives, including but not limited to infection, swelling, pain, bleeding, scarring, scar or wound enlargement, keloid formation, asymmetry, temporary or permanent alteration in sensation, allergic reaction, discoloration and the need for additional or multiple surgery
4. I understand the explanation that I received is not exhaustive and that during the course of the operation or procedure unforeseen conditions may arise which necessitate procedures different from those contemplated. I therefore authorize the above physician and assistants or designees to perform such other operations and 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 require treatment and are not known to my physician at the time the procedure is begun.
5. For the purpose of advancing medical knowledge and education, I consent to photographing, videotaping or televising of the operation or procedure to be performed. That includes but not limited to still or motion pictures and closed circuit television. I hereby grant permission for the use of any record, illustration, photograph or other imaging record created in my case, for use in examination, testing, credentialing and certifying purposes, scientific research and publications, or justification of treatment including but not limited to ABPS, American Board of Plastic Surgery and ASPS, American Society for Plastic Surgery and specifically wave any rights of compensation or privileges associated therewith. I also consent to the admission to the operating or treatment room.
6. Any organs or tissues surgically removed may be examined and retained by the Hospital / Ambulatory Center / Pathology Lab for medical, scientific, or educational purposes and such tissues or parts may be disposed of in accordance with custom and practice.
7. I acknowledge that no guarantees or assurances have been made to me concerning the results intended from the operation or procedure or anesthesia.
8. I understand that it may be required to administer anesthetics for the abovementioned procedure. The type of anesthesia may include a combination of local subcutaneous anesthetic infiltration (with or without epinephrine), sedation (the method of delivery is intravenous or mask), or general, including intubations (placing a breathing tube). I also recognize the circumstances may change necessitating another type or mode of delivery of anesthesia. I also authorize changes to another form of anesthesia as is considered necessary for my or the patient well being during this operation, procedure or treatment. I recognize that there are risks to life and health associated with anesthesia and such risks as well as benefits and alternatives have been fully explained to me and I have had a chance to ask and have my questions answered.
9. I am aware that among those who attend patients is medical, nursing and other health care personnel in training, who unless requested otherwise, may participate in-patient care as a part of their education. I further consent to the presence of service representatives and/or technicians from manufacturers of equipment or devices to assist in performing and/or operation of such equipment and/or devices during operation, procedure and treatment, including but not limited to CO2 laser.
10. If I have a DNR/DNI in place I consent to the suspension of the DNR/DNI during the above named operation, procedure or treatment.
11. I consent to the administration of blood, blood components and/or derivatives, medications, treatments and therapies as may be deemed advisable in the judgments of the attending physician or designated associates or assistants. The reasonably foreseeable risks and benefits involved in my/patient’s receipt of such medications, therapies, and administration of blood, blood components and / or derivatives had been explained to me. I understand that the risks of receiving blood, blood components or derivatives, including but not limited to the transmission of HIV or hepatitis infection, other blood borne infections, exists despite the fact the blood had been tested. The alternatives of not receiving this therapy had been explained to me. Should I, or the patient, be administered blood, blood components and / or derivatives, I agree to report any signs or symptoms of disease to my doctor or to the Blood Bank.
12. I authorize the release of my Social Security Number to appropriate agencies for legal reporting and medical device registration, if applicable.
13. I confirm that I have read fully understand all above and that all blank spaces were completed prior to my signing. I have crossed out any paragraphs which do not pertain to me.
14. I understand that the surgeons’ fees are separate from the anesthesia and hospital charges, and the fees are agreeable to me. If a secondary procedure is necessary, further expenditure will be required.
15 I realize that not having the operation is an option.
16. I have received, read and initialed the following information sheet: INFORMED CONSENT – NIPPLE RECONSTRUCTION SURGERY provided by the doctor. I consent to the treatment or procedure and the above listed items 1-16. I had been given the opportunity to ask additional questions and I am satisfied with the explanation. . I wish to proceed.