This form is designed to give you the information you need to make an informed choice on whether or not to undergo breast augmentation surgery. 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 surgeon and agreed upon by you. If you have any questions, please do not hesitate to ask us. Although this type of surgery is generally very effective, no guarantee can be made that a specific outcome will be achieved from the treatment.

What is breast augmentation?

Breast Augmentation is a surgical operation where synthetic implants are placed under the breast tissue or pectoral muscle. It is performed for a number of reasons:

• To enhance the body contour of a woman who, for personal reasons, feels that her breast size is too small.
• To correct a loss in breast volume after pregnancy.
• To balance breast size when there exists a significant difference between the size of the breasts.
• As a reconstructive technique for various conditions.
• Replacement of breast implants for medical or cosmetic reasons.

Implants are generally made from cohesive silicone gel with a solid silicone shell. Some implants have an external micropolyurethane foam coating. Implants may have round or oval base; may have a round or anatomical (“teardrop”) profile; and vary in level of projection (also known as profile). Saline-filled implants are still available but much less commonly used since the advent of improved cohesive silicone gel implants.

In a “removal/replacement” operation, the existing implants are first removed. Sometimes the “capsule” or tissue membrane surrounding the implant is also removed or surgically widened. In other cases, a new pocket may be created in a different tissue plane.

How is it done?

Under a general anaesthesia, incisions are made (usually in the fold under the breasts, but sometimes around the areola or in the armpit). Local anaesthetic may be infiltrated into the tissues. A pocket to hold the implant is created surgically, and the implant is put in to the pocket. Final adjustments are made and then the incision is closed with internal sutures. The procedure is repeated on the other side.

WHAT ARE THE POSSIBLE SIDE-EFFECTS AND COMPLICATIONS?

The most common side effects and complications of breast augmentation surgery are: Pain, swelling, bruising, movement limitation.

There is usually little or no discomfort during the procedure. There may be some general discomfort for several days following the procedure, especially if the implants are positioned behind the pectoral muscle. This gradually disappears with time.

Bruising occasionally occurs with this procedure. Bruising is not serious and does not indicate that anything is wrong. It resolves in 10 to 14 days. Some swelling is always present for several weeks, gradually resolving with time.

Movements of the arms from shoulder level may be uncomfortable and/or limited for several days.

Haematoma/Seroma

In rare cases, a vessel may continue to bleed after surgery, leading to a large clot or haematoma. This will present as increasing pain and swelling on one side, sometimes with visible dusky discoloration. The surgeon should be informed immediately and in severe cases, surgical exploration may be undertaken to find and stop the source of the bleeding.

Seroma is a rare complication where a fluid sac develops near the implant. It can usually be easily drained.

Infection

Infection is rare but may occur with any surgical procedure. Usually it resolves with antibiotics, but in severe cases, the infected implant may need to be removed. It can be replaced at a later stage once the infection has settled.

If the surgical incision becomes infected, this may cause it to open up. This will require corrective surgery.

Malposition/asymmetry/rotation

The two sides of the human body are never completely symmetrical and can never be made completely symmetrical. Asymmetry of breasts is especially common and will usually persist following breast augmentation surgery. However, in some instances the asymmetry can be improved by surgery. This will be discussed during the consultation process.

Implants often drop slightly from their initial position during the months following surgery. If this only occurs on one side, an asymmetry will result. Poor positioning of the implants by the surgeon is another possible cause of malposition/asymmetry.

A small degree of malposition and/or asymmetry is usually acceptable, but in more obvious cases, corrective surgery will be necessary.

Nipple/Areola problems

Generally, the nipple/areola complex (NAC) will stretch following breast augmentation. This may be an issue for women with large NACs. Loss of sensation, even complete numbness of the NAC, is possible but fortunately quite rare. It is thought that breastfeeding may be affected in a small number of cases. However, there is still no conclusive evidence regarding this.

Other appearance problems

Stretch marks may form in the breast skin after the procedure, although this is rare. Stretch marks often resolve almost completely after several months. However, faint white lines will most likely persist.

Rippling is a condition where the implant shell is folded, and the folds are visible at the surface, looking a little like curtain folds. Rippling may only be visible in certain positions, such as when bending forward. Spontaneous resolution is unlikely and corrective surgery may be necessary. The edges of the implant may be palpable or visible. This is usually most problematic when the upper edge is clearly visible, as it may be exposed when wearing low-cut tops. This problem is more likely with implant placement in front of the pectoral muscle, and/or with very high-profile round implants.

If the implant is wider than the breast tissue, the bottom edge may be visible as a “double bubble”. Careful assessment by the surgeon will lead to an implant size recommendation which, if adhered to, should avoid this complication. Patients who insist on an implant size which differs from the surgeon’s recommendation must accept that there is an increased risk of such outcomes. Signing of this consent form indicates an understanding and acceptance of this risk. Implant rupture

Modern implants are extremely sturdily constructed. The outer shell usually consists of three layers, including a middle layer of polyurethane which gives extra strength to the shell. Nevertheless, rupture of the shell may occur, especially following chest trauma. Extrusion of the silicone gel is possible, but often very limited due to the cohesive nature of the material (which is a bit like Turkish Delight).

A sudden onset of pain in one breast, with or without swelling, may lead to a suspicion of rupture, especially if it occurs following an injury or blow to the chest area. The diagnosis can be confirmed by breast ultrasound and (sometimes) MRI studies. Mild, limited ruptures may be treated conservatively. More extensive ruptures usually require removal and replacement of the implant, including thorough removal of any extruded silicone.

Capsular contracture

All surgically implanted foreign bodies cause a surrounding tissue reaction. In most cases, the body will form a thin fibrous membrane or “capsule” around the breast implant. However, in some cases this capsule can thicken and start to contract, causing deformation of the implant within. Severe cases cause pain, hardening and visible deformity, which may occur on one or both sides. Capsular contracture can occur within months of surgery but can also first appear several years later. Severe cases will require removal and replacement of the implant, usually into a different plane. Unfortunately, recurrence rates are high.

Anaplastic Large Cell Lymphoma (ALCL)

Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)is a rare form of cancer. To date no Australian cases have been reported in women who have only had smooth implants.

BIA-ALCL usually involves a swelling of the breast, typically 3 to 14 years insertion of breast implants. This swelling is due to an accumulation of fluid. Less commonly, BIA-ALCL can take the form of a lump in the breast or a lump in the armpit. Although fatalities have been recorded, the vast majority of BIA- ALCL are cured by removal of the implant and the capsule surrounding the implant. Because BIA-ALCL is rare, experts do not recommend removal of breast implants where there are no problems with the implant.

Based on the currently available data, it is not possible to provide an accurate estimate of risk. Current expert opinion puts the risk of ALCL at between 1-in-1,000 and 1-in-10,000, and based on currently available data, Mentor implants (primarily used by Cosmetic Avenue) have one of the lowest rates of BIA-ALCL of 1 in 86,029. Most (95%) of cases of breast implant-associated ALCL occur between 3 and 14 years after insertion (median: 8 years; range: 1-37 years).

It can be difficult to express this risk in a concrete way, such that you can make a fully informed decision about whether or not to have breast implants. Some different ways of expressing the risk are given below:

One woman will be diagnosed with breast implant-associated ALCL for every 1,000 to 10,000 women with breast implants. For example, if we took 1-in-5000 women, the middle of the experts' range, as the best estimate of risk of ALCL in women who have breast implants. This would mean that, of 5,000 women with implants, one woman will develop ALCL over a period of about 3-14 years following insertion; the other 4999 women will not develop ALCL.

Surgical Anesthesia

Both local and general anesthesia involves risk. There is the possibility of complications, injury, and even death from all forms of surgical anesthesia or sedation.

Deep Vein 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 due 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 and even fatal complications. Air travel, inactivity and other conditions may increase the incidence of blood clots traveling to the lungs and causing a major blood clot that may result in death. It is important to discuss with your surgeon any past history of blood clots, swollen legs or the use of estrogen or birth control pills, which may contribute to unwanted clotting. Cardiac complications are a risk with any surgery, even in patients without a history of heart problems. Should any of these complications occur, you may require hospitalization and additional treatment. If you experience shortness of breath, chest pain, or unusual heartbeats, seek medical attention immediately.

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. 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 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 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 which you are already taking. If you have an adverse reaction, stop the drugs immediately and call your 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 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.

Who should not have breast augmentation surgery?

Patients with severe illness or unrealistic expectations should not undergo this type of surgery. Patients under the age of 18 years with no clear medical reason (such as reconstruction following mastectomy or injury, or congenital breast deformity) may be restricted by Australian law from having the procedure.

Breast augmentation surgery is also not advisable 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 those that have reduced blood supply to the breast tissue from prior surgery or radiation therapy treatments may be at greater risk for complications and poor surgical outcome.

Mental Health Disorders and Elective Surgery

It is very important that all patients wishing to undergo elective surgery have realistic expectations regarding their surgical results. Though we hope to achieve a significant improvement with surgery, it must be understood that perfection, or the “aesthetic ideal”, cannot be obtained. Complications, or less than satisfactory results, may require more surgery. Adjusting to the results of surgery, and/or coping with additional surgery, is often stressful. Prior to surgery, please openly discuss with us any history of significant emotional depression or mental health disorders, although many individuals may benefit psychologically from the results of elective surgery, the effects that cosmetic surgery has on mental health cannot accurately be predicted.

PATIENT COMPLIANCE

Follow all surgeon 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 work related activity needs to be restricted. Protective dressings and drains should not be removed unless instructed by your 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.

ADDITIONAL SURGERY NECESSARY (Re-Operations)

There are many variable conditions that may influence the long-term result of breast augmentation 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 time in the future to replace your breast implants or to improve the outcome of breast augmentation surgery. 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 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.

FINANCIAL RESPONSIBILITIES

The total cost of surgery includes surgeon fees, hospital fees, anesthesia, and follow up appointments for 6 months. 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 charges involved with revision surgery will be your responsibility. In signing the consent for this surgery/procedure, you acknowledge that you have been informed about its risks and consequences and accept responsibility for the clinical decisions that were made along with the financial costs of all future treatments.

PROCEDURAL IMAGES

I hereby give consent to be filmed/photographed during my procedure and understand my face will not be included in the photographs or videos nor will I be identified by name. I understand the videos/photos may be used for medical training purposes and patient education through the Cosmetic Avenue website and social media platforms.

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 surgeon may provide you with additional or different information which is based on all the facts in your particular case and the 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.

I hereby authorize Dr. Tony Prochazka and such assistants as may be selected to perform the following procedure or treatment:

Breast Augmentation Surgery

By my signature below, I certify that I have been informed of the following:

• the potential benefits of the proposed procedure
• alternative procedures that may be suitable for my condition
• the prospects of success
• the reasonable anticipated consequences if the procedure is not performed
• the major risks involved in the proposed procedure (listed above).

I understand that the practice of medicine and surgery is not an exact science, and that therefore reputable practitioners cannot properly guarantee results. I acknowledge that no guarantee or assurance has been made by anyone regarding the procedure which I have requested and authorised.

I have discussed any concerns I may personally have about this treatment, namely (fill in any personal concerns which were discussed):

and was satisfied with the answers I received.

I have advised my doctor of any medical conditions or other circumstances which, to my knowledge, may render this treatment unsafe for me.

I certify that I have read and fully understood the contents of this form and the disclosures referred to above that were made to me. I hereby consent to treatment as outlined above. I also consent to the taking of photographs for the medical record and further consent to their use for research, teaching or publication, with the understanding that I will not be identified or identifiable from such photos.