CONSENT FOR OPEN CAPSULOTOMY

DARRYL J. HODGKINSON M.D. F.R.C.S.(C) F.A.C.S.

This is an informed-consent document that has been prepared to help inform you about open capsulotomy, its risks and alternative treatments. It is important that you read this information carefully and completely.

General Information

Open capsulotomy is a surgical operation performed to treat scarring which occurs around breast implants. Individuals with old, damaged or broken implants may consider open capsulotomy surgery as a procedure to maintain the long-term results from their original surgery.

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, implant replacement, or implant removal.

1.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 capsulectomy procedure may be placed in different locations than those used for the original surgery.

2. 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 open capsulotomy.

a. 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 (haematoma). Do not take any aspirin or anti- inflammatory medications for ten days before surgery, as this may increase the risk of bleeding.

b. Infection - 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. Ubacute 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

c. Recurrent capsular contracture- Excessive firmness of the breasts can recur soon after capsulectomy surgery or years later. Scar tissue, may form again around the breast implant; it can tighten and make the breast round, firm, and possibly painful. The recurrence of symptomatic capsular contracture following capsulectomy is not predictable. The incidence of symptomatic capsular contracture can be expected to increase over time. Capsular contracture may recur on one side, both sides or not at all. Treatment for recurrent capsular contracture may require additional surgery, or implant removal.

d. Change in nipple and skin sensation- Some change in nipple sensation is not unusual right after surgery. After several months, most patients have normal sensation. Partial or permanent loss of nipple and skin sensation may occur occasionally.

e. Skin scarring- Excessive scarring is uncommon. In rare cases, abnormal scars may result. Scars may be unattractive and of different colour than surrounding skin. Additional surgery may be needed to treat abnormal scarring after surgery.

f. Skin wrinkling and rippling- Visible and palpable wrinkling of implants can occur. Some wrinkling is normal and expected. This may be more pronounced in patients who have saline-filled implants or thin breast tissue. It may be possible to feel the implant valve. Some patients may find palpable valve and wrinkles cosmetically undesirable. Palpable valve, wrinkling and/or folds may be confused with palpable tumours and questionable cases must be investigated. An implant may become visible at the surface of the breast as a result of the device pushing through layers of skin.

g. Implant displacement- Displacement or migration of a breast implant may occur from its initial placement and can be accompanied by discomfort and/ordistortion in breast shape. Difficult techniques of implant placement may increase the risk of displacement or migration. Additional surgery may be necessary to correct this problem.

h. Surgical anaesthesia- Both local and general anaesthesia involve risk. There is the possibility of complications, injury, and even death from all forms of surgical anaesthesia or sedation.

i. 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.

k. Allergic reactions- In rare cases, local allergies to tape, suture material, or topical preparations have been reported. Systemic reactions which are more serious may result from drugs used during surgery and prescription medicines. Allergic reactions may require additional treatment.

l. Seroma- Fluid may accumulate around the implant following surgery, trauma or vigorous exercise. Additional treatment may be necessary to drain fluid accumulation round breast implants.

m. Breast disease- Current medical information does not demonstrate an increased risk of breast disease or breast cancer in women who have breast implant surgery for either cosmetic or reconstructive purposes. Breast disease can occur independently of Breast implants. It is recommended that all women perform periodic self examination of their breasts, have mammography and seek professional care should they notice a breast lump.

n. Unsatisfactory result- You may be disappointed with the results of surgery. Asymmetry in implant placement, breast shape and size may occur after surgery. Unsatisfactory surgical scar location or displacement may occur. Pain may occur following surgery. It may be necessary to perform additional surgery to improve your results.

3. I have an understanding of the operation which includes but is not limited to the above items. I understand that secondary revisions may be required in some cases. I also understand that charges will be made for the use of the operating room, whether in the day surgery or in the hospital, and for any implants or other materials required. I agree to be responsible for these charges.

4. I recognise that, during the course of the operation, unforeseen conditions may necessitate additional or different procedures than those outlined. I, therefore, further authorise and request that the above-named surgeon or his/her assistants perform such procedures as are, in his or her professional judgment, necessary and desirable. The authority granted under this Paragraph 4 shall extend to remedying conditions that are not known to or could not reasonably be anticipated by the above doctor(s) at the time the operation is commenced.

5. I consent to the administration of local or general anaesthetic agents by or under the direction and supervision of the above doctor(s), and anaesthetist working with them.

6. I am aware that the practice of medicine and surgery is not an exact science, and I acknowledge that no guarantees have been made to me as to the results of the operation or procedure; nor are there any guarantees against unfavourable results.

7. I consent to be photographed before, during and after the surgery; that these photographs shall be the property of the above doctors and may be used as they deem proper for scientific and educational purposes.

8. I agree to keep the above doctor(s) informed of any change of address, and I agree to cooperate with them in my care after surgery until completely discharged.

9. I understand that the doctors’ fees are separate from the anaesthesia and hospital charges, and implant costs and the doctors’ fees are agreeable to me. There may be a fee if a secondary procedure is required. Personal expectations vary; please ensure that you have liaised with your doctor and he has understood your expectations of surgery. Some operations require secondary or multiple procedures to obtain a better result.

10. Secondary surgical procedures are much more difficult than primary procedures. The operations for repair are much more complex than the primary operations because of scarring and more bleeding and bruising. The possibility of nerve damage and poor healing is greater and most importantly, the results are unpredictable. It is important for the patient to realise that the results of secondary surgery will never be as predictable as those of primary surgery. If a secondary procedure is necessary, further expenditure will be required, namely surgeon’s fees, the use of the operating room, anaesthesia and possibly hospitalisation. Before embarking on secondary surgery, you should be aware of your possible future commitments to multiple procedures in order to gain an acceptable result for yourself.

11. I have read a copy of the foregoing consent for the operation, understand it, accept these facts, and hereby authorise the above doctor(s) to perform this surgical procedure on me.

IF THE PATIENT IS A MINOR, COMPLETE THE FOLLOWING

The patient is a minor of ______ years of age; and we, the undersigned, are the parents or legal guardian of the patient and do hereby consent for the patient.

Parent or Legal Guardian ______________________________________________________________

Witness____________________________________________________________________________

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