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INSTRUCTIONS

This is an informed-consent document that has been prepared to help inform you about open capsulotomy and breast implant exchange using saline-filled implants, its risks, and alternative treatments.

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.

GENERAL INFORMATION

The open capsulotomy is a surgical operation performed to treat scarring which occurs around breast implants or to revise the shape of the pocket where the implant is placed. This usually involves surgical cutting of scar tissue that forms around a breast implant and the placement of a new breast implant.

Scar tissue, which forms internally around a breast implant, can tighten and make the breast round, firm, and possibly painful. Excessive firmness of the breasts can occur soon after the original surgery or years later. The incidence of symptomatic capsular contracture can be expected to increase over time. Capsular contracture may occur on one side, both sides or not at all. Calcification can occur within the scar tissue that surrounds breast implants. Treatment for capsular contracture may require surgery, removal of the capsule layer, implant replacement, or implant removal. Patients may elect to increase or decrease the size of their breast implants.

Individuals with old, damaged or broken implants may consider open capsulotomy surgery and breast implant exchange as a way to maintain the long-term results from their original surgery, whether for cosmetic or reconstructive purposes. You may be advised by your surgeon to consider replacing your breast implants with new ones, irrespective of how long you have had them. In some situations, you may be advised to consider new breast implants with a textured outer surface or to consider saline-filled implants. Patients undergoing open capsulotomy surgery and breast implant exchange must consider the possibility of future revisionary surgery. Breast implants do not have an indefinite lifespan and will eventually require surgery for removal and/or replacement.

Depending on the extent of the scarring problem, it may be necessary to place the implant in a deeper location, underneath the pectoralis muscle on the chest. Incisions for the open capsulotomy procedure may be placed in different locations than those used for the original surgery. If the breasts are not the same size or shape before surgery, it is unlikely that they will be completely symmetrical afterward. Conditions which involve sagging of the breast or diminished skin tone (stretch marks) may require additional surgical procedures (breast lift) to reposition the nipple and areola upward and to remove loose skin. Additional procedures to internally tighten or reshape the implant pocket may be needed to reposition implants.

SALINE-FILLED BREAST IMPLANTS

Saline-filled breast implant devices have been approved by the United States Food and Drug Administration (USFDA) for use in breast augmentation and reconstruction. Saline-filled breast implants can be used for revision of patients who have formerly undergone breast augmentation or reconstruction with silicone gel or saline-filled breast implants.

Breast implant surgery is contraindicated in women with untreated breast cancer or pre-malignant breast disorders, active infection anywhere in the body, or individuals who are currently pregnant or nursing. Individuals with a weakened immune system (currently receiving chemotherapy or drugs to suppress the immune system), conditions that interfere with blood clotting or wound healing, or have reduced blood supply to the breast tissue from prior surgery or radiation therapy treatments may be at greater risk for complications and a poor surgical outcome. According to the USFDA, a woman should be at least 18 years of age for cosmetic breast augmentation.

Breast implants are manufactured in a variety of shapes, sizes, and with either smooth or textured surfaces. The method of implant selection and size, along with surgical approach for inserting and positioning breast implants will depend on your preferences, your anatomy and your surgeon’s recommendation. The shape and size of the breasts prior to surgery will influence both the recommended treatment and the final results. If the breasts are not the same size or shape before surgery, it is unlikely that they will be completely symmetrical afterward.

Patients undergoing open capsulotomy with implant replacement using saline-filled implants must consider the following:

  • Breast augmentation or reconstruction with saline-filled implants may not be a one time surgery.
  • Breast implants of any type are not considered lifetime devices. They cannot be expected to last forever. You will likely require future surgery for implant replacement or removal.
  • Changes that occur to the breasts following augmentation or reconstruction with implants are not reversible. There may be an unacceptable appearance to the breast if you later choose to have breast implants removed.

ALTERNATIVE TREATMENTS

Open capsulotomy with implant replacement using saline-filled implants is an elective surgical operation. Alternative treatment would consist of not undergoing the surgical procedure, using silicone gel-filled breast implants, or the transfer of other body tissues to rebuild breast size. Risks and potential complications are also associated with alternative surgical forms of treatment. Implant removal without replacement is also a surgical option, if you elect to abandon the use of breast implants.

RISKS OF OPEN CAPSULOTOMY WITH IMPLANT REPLACEMENT USING SALINE-FILLED IMPLANTS 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.

Additional information concerning breast implants may be obtained from the USFDA, package-insert sheets supplied by the implant manufacturer, or other information pamphlets required by individual state laws.

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 understand all possible consequences of breast augmentation revision. Problems associated with breast implants can be inherent to this type of implanted medical device or relate to complications of a surgical procedure. Additional advisory information regarding this subject should be reviewed by patients considering surgery that involves breast implants.

While every patient experiences her own individual risks and benefits following breast implant surgery, clinical data suggests that most women will be satisfied with the outcome of breast implant surgery despite the occurrence of problems inherent with the surgery.

Inherent Risks of Saline-Filled Breast Implants

  • Implants – Breast implants, similar to other medical devices, can fail. When a saline-filled implant ruptures, the saline material is absorbed by the body, but the shell material remains. Rupture can occur as a result of an injury, from no apparent cause (silent rupture), or during mammography. It is also possible to damage an implant at the time of surgery. Damaged or broken implants cannot be repaired. Ruptured or damaged implants require replacement or removal. Breast implants can wear out, they are not guaranteed to last a lifetime and future surgery may be required to replace one or both implants. A MRI (magnetic resonance imaging) study may be necessary to evaluate the possibility of implant rupture or deflation, yet it may not be 100% accurate in diagnosing implant integrity. Saline-filled breast implants may not have the same contour or feel as silicone filled breast implants. The shape of your breasts after surgery depends on many factors such as your skin thickness, position and placement of the implants, and the surgical technique used. You should discuss with your surgeon about the possibility of a different and less than desirable contour-shape as well as the feel of your result.

  • Capsular Contracture – Scar tissue, which forms internally around the breast implant, can tighten and make the breast round, firm, and possibly painful. Excessive firmness of the breasts can occur soon after surgery or years later. The occurrence of symptomatic capsular contracture is not predictable. The incidence of symptomatic capsular contracture can be expected to increase over time. Capsular contracture may occur on one side, both sides or not at all. It is more common with implant placement in front of the chest muscle layer. Treating capsular contracture may require surgery, implant replacement, or implant removal. Capsular contracture may reoccur after surgical procedures to treat this condition.

  • Implant Extrusion / Tissue Necrosis – Lack of adequate tissue coverage or infection may result in exposure and extrusion of the implant through the skin. Tissue breakdown (necrosis) has been reported with the use of steroid drugs, after chemotherapy/radiation to breast tissue, due to smoking, microwave diathermy, and excessive heat or cold therapy. In some cases, incision sites fail to heal normally. An implant may become visible at the surface of the breast as a result of the device pushing though layers of skin. If tissue breakdown occurs and the implant becomes exposed, implant removal may be necessary. Permanent scar deformity may occur.

  • Skin Wrinkling and Rippling – Visible and palpable wrinkling of implants and breast skin can occur. Some wrinkling is normal and expected with saline-filled breast implants. This may be more pronounced in patients who have saline-filled implants with textured surfaces or thin breast tissue. It may be possible to feel the implant fill valve. Some patients may find palpable valve and wrinkles cosmetically undesirable. Palpable wrinkling and/or folds may be confused with palpable tumors and questionable cases must be investigated.

  • Calcification – Calcium deposits can form in the scar tissue surrounding the implant and may cause pain, firmness, and be visible on mammography. Removal of calcifications around breast implants requires capsulectomy surgery. These deposits must be identified as different from calcium deposits that are a sign of breast cancer. Should this occur, additional surgery may be necessary to remove and examine calcifications.

  • Chest Wall Irregularities – Chest wall irregularities have been reported secondary to the use of tissue expanders and breast implants. 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.

  • Implant Displacement and Tissue Stretching – Displacement, rotation, or migration of a breast implant may occur from its initial placement and can be accompanied by discomfort and/or distortion in breast shape (visible rippling of the skin). Unusual techniques of implant placement may increase the risk of displacement or migration. Additional surgery may be necessary to attempt to correct this problem. It may not be possible to resolve this problem once it has occurred.

  • Surface Contamination of Implants – Skin oil, lint from surgical drapes, or talc may become deposited on the surface of the implant at the time of insertion. The consequences of this are unknown.

  • Unusual Activities and Occupations – Activities and occupations which have the potential for trauma to the breast could potentially break or damage breast implants or cause bleeding/seroma.

  • Inherent Surgical Risk of Open Capsulotomy With Implant Replacement Using Saline – Filled Implants 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 or blood transfusion. Intra-operative blood transfusion may also be required. Hematoma may contribute to capsular contracture, infection or other problems. 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.

  • Seroma – Fluid may accumulate around the implant following surgery, trauma or vigorous exercise. Additional treatment may be necessary to drain fluid accumulation around the breast implants. This may contribute to infection, capsular contracture, or other problems.

  • Infection – Although infection is unusual after this type of surgery, it may appear in the immediate post-operative period or at any time following the insertion of a breast implant. Subacute or chronic infections may be difficult to diagnose. Should an infection occur, treatment including antibiotics, possible removal of the implant, or additional surgery may be necessary. Infections with the presence of a breast implant are harder to treat than infections in normal body tissues. If an infection does not respond to antibiotics, the breast implant may have to be removed. After the infection is treated, a new breast implant can usually be reinserted. It is extremely rare that an infection would occur around an implant from a bacterial infection elsewhere in the body, however, prophylactic antibiotics may be considered for subsequent dental or other surgical procedures. In extremely rare instances, life-threatening infections, including toxic shock syndrome have been noted after breast implant surgery. Individuals with an active infection in their body or weakened immune system should not undergo breast augmentation.

  • Scarring – All surgery leaves scars, some more visible than others. Excessive scarring is uncommon. Although good wound healing after a surgical procedure is expected, abnormal scars may occur within the skin and deeper tissues. 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.

  • 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.

  • 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 in response to drugs used during surgery and prescription medicines. Allergic reactions may require additional treatment.

  • Thrombosed Veins – Thrombosed veins, which resemble cords, occasionally develop in the area of the breast and usually resolve without medical or surgical treatment.

  • Change in Nipple and Skin Sensation – You may experience a diminished (or loss) of sensitivity of the nipples and the skin of your breast. After several months, most patients have normal sensation. Partial or permanent loss of nipple and skin sensation may occur occasionally. Changes in sensation may affect sexual response or the ability to breast feed a baby.

  • Pain – You will experience pain after your surgery. Pain of varying intensity and duration may occur and persist after breast implant surgery. Pain may be the result of improper implant size, placement, surgical technique, capsular contracture, or sensory nerve entrapment or injury. Chronic pain may occur very infrequently from nerves becoming trapped in scar tissue or due to tissue stretching.

  • Ruptured Saline – Filled Breast Implants As with any man made object implanted in the human body, device failure can occur. Implants also can rupture during the removal process. Implant shell material of textured breast implants may be impossible to completely remove. Calcification around implants can occur and may require removal of the scar tissue surrounding the implant (capsulectomy). It may not be possible to completely remove the scar tissue that has formed around a breast implant, implant parts, or calcifications. Additional surgery may be necessary in the future.

  • Skin Discoloration / Swelling – Some bruising and swelling normally occurs after breast augmentation revision surgery. 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.

  • 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.

  • Asymmetry – Some breast asymmetry naturally occurs in most women. Differences in terms of breast and nipple shape, size, or symmetry may also occur after surgery. Additional surgery may be necessary to attempt improvement of asymmetry after a breast augmentation revision.

  • Damage to Deeper Structures – There is the potential for injury to deeper structures including nerves, blood vessels and muscles and lungs (pneumothorax) during this 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.

  • 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. Areas of skin or nipple tissue may die. This may require frequent dressing changes or further surgery to remove the non-healed tissue. Individuals who have decreased blood supply to breast tissue from past surgery or radiation therapy may be at increased risk for wound healing and poor surgical outcome. Smokers have a greater risk of skin loss and wound healing complications.

  • Cardiac and Pulmonary Complications – 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 swelling in your legs or blood clots that may contribute to this condition. Cardiac complications are a risk with any surgery and anesthesia, even in patients without symptoms. Should any of these complications occur, you may require hospitalization and additional treatment. If you experience shortness of breath, chest pain, or unusual heart beats, you should seek medical attention immediately.

  • 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.

Additional Advisories Regarding Saline-Filled Breast Implant Surgery

  • Mammography – Breast implants may make mammography more difficult and may obscure the detection of breast cancer. Any breast implant can impair the detection of breast cancer, regardless of the type of implant or where it is placed in relation to the breast. Implant rupture can occur from breast compression during mammography. Inform your mammography technologist of the presence of breast implants so that appropriate mammogram studies may be obtained. Patients with capsular contracture may find mammogram techniques painful and the difficulty of breast imaging will increase with the extent of contracture. Ultrasound, specialized mammography and MRI studies may be of benefit to evaluate breast lumps and the condition of the implant(s). Because more x-ray views are necessary with specialized mammography techniques, women with breast implants will receive more radiation than women without implants who receive a normal exam. However, the benefit of the mammogram in finding cancer outweighs the risk of additional x-rays. Patients may wish to undergo a preoperative mammogram and another one after implantation to establish a baseline view of their breast tissue. You may be advised to undergo a MRI study in the future to verify the condition of your breast implants inside your body.

  • Second-Generation Effects – A review of the published medical literature regarding the potential damaging effect on children born of mothers with breast implants is insufficient to draw definitive conclusions that this represents a problem.

  • Breast Feeding – Breast milk is the best food for babies. Many women with breast implants have successfully breast fed their babies. It is not known if there are increased risks in nursing for a woman with breast implants. A study measuring elemental silicon (a component of silicone in a breast implant shell) in human breast milk did not indicate higher levels from women with silicone gel- or saline-filled implants when compared to women without implants. Cow’s milk contains higher levels of elemental silicon as compared to human milk. Implant placement techniques that involve incisions through the nipple and areola locations may reduce the ability to successfully breast feed. If a woman has undergone a mastectomy, it is unlikely that she would be able to breast feed a baby on the side where the breast was removed.

  • Long-Term Results – Subsequent alterations in breast shape may occur as the result of aging, sun exposure, weight loss, weight gain, pregnancy, menopause, or other circumstances not related to your augmentation mammaplasty revision. Breast sagginess may normally occur.

  • 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 of surgery. Asymmetry in implant placement, displacement, nipple location, unanticipated breast shape and size, loss of function, wound disruption, poor healing, and loss of sensation may occur after surgery. Breast size may be incorrect. Unsatisfactory surgical scar location may occur. In some situations, it may not be possible to achieve optimal results with a single surgical procedure. It may be necessary to perform additional surgery to improve your results, change implant size or remove and not replace implants.

  • Removal / Replacement of Breast Implants – Future revision, removal, or replacement of breast implants and the surrounding scar tissue envelope involves surgical procedures with risks and potential complications. There may be an unacceptable appearance of the breasts following removal of the implant.

  • Capsule Squeeze Procedures – Closed capsulotomy, the process of forcefully squeezing the fibrous capsule around a breast implant to break up scarring, is not recommended. This may result in rupture of the breast implant, bleeding or other complications.

  • Immune System Diseases and Unknown Risks – A small number of women with breast implants have reported symptoms similar to those of known diseases of the immune system, such as systemic lupus erythematosis, rheumatoid arthritis, scleroderma, and other arthritis-like conditions. To date, after several large epidemiological studies of women with and without implants, there is no scientific evidence that women with either saline-filled or silicone gel-filled breast implants have an increased risk of these diseases. These diseases appear no more common in women with implants than those women without implants. The effect of breast implants in individuals with pre-existing immune system and connective-tissue disorders is unknown. There is the possibility of unknown risks associated with saline breast implants and tissue expanders.

  • Breast and Nipple Piercing Procedures – Individuals with breast implants seeking to undergo body piercing procedures to the breast region must consider the possibility that an infection could develop anytime following this procedure. Should an infection occur, it is possible that it could spread to the breast implant space. Treatment including antibiotics, possible removal of the implant, or additional surgery may be necessary. Infections with the presence of a breast implant are harder to treat than infections in normal body tissues. If an infection does not respond to antibiotics, the breast implant may have to be removed. Individuals who currently wear body-piercing jewelry in the breast region are advised that a breast infection could develop.

  • Interference with Sentinel Lymph Node Mapping Procedures – Breast augmentation procedures (periareolar or transmammary) that involve cutting through breast tissue, similar to a breast biopsy in order to place breast implants, can potentially interfere with diagnostic procedures to determine lymph node drainage of breast tissue to stage breast cancer. If this is a concern, individuals considering breast augmentation revision by these approaches may elect to consider another surgical approach (inframammary or standard periareolar).

  • Large Volume Breast Augmentation – Patients who request an outcome of augmentation mammaplasty revision that produces disproportionately large breast size must consider that such a choice can place them at risk for a less than optimal long-term outcome and the need for re-operation and additional expenses. The placement of excessively-sized breast implants exceeds the normal dimensions of the breast, produce irreversible tissue thinning, implant drop out, and visible/palpable rippling.

  • 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.

  • Female Patient Information – It is important to inform your plastic surgeon if you use birth control pills, estrogen replacement, or if you suspect that you are pregnant. Many medications including antibiotics may neutralize the preventive effect of birth control pills, allowing for conception and pregnancy.

  • 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 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 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.

  • Breast Implant Technology / Technologic Improvements in Breast Implants – The technology of breast implant design, development and manufacture will continue to progress and improve. Newer or future generations of implants may be better in some way from currently available ones.

  • 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.

ADDITIONAL SURGERY NECESSARY (Re-operations)

There are many variable conditions that may influence the long-term result of breast augmentation revision surgery. It is unknown how your breast tissue may respond to implants or how wound healing will occur after surgery. Secondary surgery may be necessary at some unknown time in the future to replace your breast implants or to improve the outcome of breast augmentation surgery. You may elect to or be advised to have your breast implants removed and not replaced in the future. Should complications occur, additional surgery or other treatments may be necessary. Even though risks and complications occur infrequently, the risks cited are particularly associated with breast augmentation revision 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.

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 subsequent care. Physical activity that increases your pulse or heart rate may cause bruising, swelling, fluid accumulation around implants 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.

REGULATORY MATTERS

According to USFDA regulations, you must comply with the submission of personal information to a device registry before surgery and afterwards.

HEALTH INSURANCE

Most health insurance companies exclude coverage for cosmetic surgical operations such as a breast implant revision surgery or any complications that might occur from surgery. Some carriers have excluded breast diseases in patients who have breast implants. Please carefully review your health insurance subscriber-information pamphlet. Most insurance plans exclude coverage for secondary or revisionary surgery due to complications of cosmetic surgery.

FINANCIAL RESPONSIBILITIES

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. You may be advised some time in the future to have a MRI (magnetic resonance imaging) scan to determine the condition of your breast implants. You would be responsible for future costs of such imaging studies. 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.

DISCLAIMER

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 that 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
OPEN CAPSULOTOMY WITH BREAST IMPLANT REPLACEMENT
USING SILICONE GEL-FILLED IMPLANTS SURGERY
□ Right Breast □Left Breast □Both Breasts

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 – OPEN CAPSULOTOMY WITH BREAST IMPLANT REPLACEMENT USING SALINE-FILLED IMPLANTS 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.