BREAST ENLARGEMENT OPERATION INFORMED CONSENT
Each patient acknowledges that she understands and accepts all the aspects below: Dr. Paul Nistor studied my photographs in detail. I have seen, understood and accept all the factors below, which will not change or which may only partially improve after breast augmentation. I fully understand and accept the fact that my breasts cannot be identical, just as their details cannot be identical, and that what I must aim for is not perfection but only the improvement of their size. The breast augmentation operation or augmentation mammoplasty is the operation by which the volume of the breasts is increased bilaterally, without producing radical changes on the general appearance and which cannot change the general asymmetries of the chest, the position of the areola and the inframammary groove. This operation represents an improvement in the appearance of the breasts and not a perfect shape from an anatomical and aesthetic point of view. Name, surname _________________________________________ This information was brought to my attention during the initial medical consultation, I have read, understood, accept and sign that following breast augmentation surgery the following may occur: GENERAL COMPLICATIONS 1. Post-operative pain Any feeling of discomfort it can be controlled with anti-algesic medication (paracetamol), anti-inflammatory and muscle relaxants. 2. Local reaction of the tissues Due to the surgical procedure, the involved tissues may show varying degrees of inflammation and edema. The final result of this operation is 6-12 months postoperatively, when the soft tissues stabilize. 3. Infection Infection occurs extremely rarely and can be avoided by strictly following the pre- and post-operative instructions, pre-operative antibiotic therapy and avoiding shaving the axillary hair for at least one month after the operation. It can appear immediately or at any time after the surgical intervention. Subacute or chronic infections can be difficult to diagnose. Treatment includes antibiotic therapy, possibly removal of the implant or other surgical procedures. Infections occurring in the presence of breast implants are difficult to treat. If the infection does not respond to antibiotic therapy, the implant must be removed. After treating the infection, a new implant can be placed. Although extremely rare, it is possible that the infection in the breast is caused by a bacterium present anywhere in the body; however, prophylactic antibiotic therapy is performed in any type of surgical intervention. In extremely rare cases, toxic-septic shock can occur. If the slightest suspicious symptom appears, please contact the doctor urgently because any untreated infection can compromise the implant, which will be removed for a determined period of time +40 747 806 422months) 4. Hemorrhage, bleeding or hematoma Although extremely rare, it is possible for a hemorrhagic episode to occur during surgery. If the hemorrhage occurs postoperatively, emergency drainage of the accumulated blood/hematoma is necessary. Aspirin and anti-inflammatory medication are contraindicated 10 days before the surgical intervention because it increases the risk of bleeding. Nutritional supplements (green tea, preparations containing Ginko Biloba, ginger, garlic, turmeric, etc.) and homeopathic medicines can increase the bleeding risk. Hematomas can appear at any time due to damage to the breast. Smokers and those who practice heavy physical activities have a tendency to increased bleeding due to the increase in arterial pressure and damage to the newly created fragile vascular network. Postoperative bleeding may also occur in case of trauma or crushing. People who have a coagulation disorder due to drug treatment or genetic causes have a higher degree of risk of this complication. This complication requires an additional surgical intervention to remove the hematoma or conservative treatment that delays the final result. 5. Defective healing The speed and manner of healing varies greatly from one individual to another and even from one area to another in the case of the same individual. In the first 6 weeks, the scar will be thin and pink, but after a few months it will start to fade, becoming stable only 1 year after the operation. During this interval, a series of changes to the scar may appear, such as: its weakening or widening (in the case of large implants), color changes, nodules and local discomfort. The development of keloid or hypertrophic scars is difficult to predict, but fortunately it rarely happens. All these aspects can influence the final appearance of the scar and may require, if they are significant, its surgical correction. Smokers have an increased risk of delayed and defective scarring. 6. Delayed, defective healing, wound dehiscence (reopening of the surgical wound) These complications can appear after surgery. There is a possibility of necrosis / destruction of certain areas of the skin. These cases require frequent dressings or even corrective surgical reinterventions. 7. Pneumothorax Due to the submuscular surgical technique, iatrogenic pneumothorax can occur, which causes pulmonary functional changes. The treatment is specific through the introduction of a pleurostomy. 8. Elongation of the axillary plexus Due to the position on the operating table, this elongation may appear in weak people or with vitamin B deficiency, which is characterized by reduced mobility and sensitivity in the upper limb. The treatment is specific with anti-inflammatory drugs and vitamin complex. 9. Anesthetic risk This operation is performed under general anesthesia and therefore all the risks involved in this aspect of the intervention must be discussed with the anesthesiologist. Anesthetic complications can be: chest infections, femoral vein thrombosis, migration of thrombi into the lungs (pulmonary thromboembolism) and even death. 10. Allergic reactions In rare cases local allergies to plasters, suture materials or antiseptic solutions may occur. Systemic allergic reactions are more serious and can occur as a result of medication administered during or after surgery. Allergic reactions require additional treatment. 11. Venous thrombosis may occur occasionally and is treated with medication and/or surgery. 12. Damage to large vessels (arteries, veins) that can cause massive bleeding and even death. SPECIFIC COMPLICATIONS 1. Capsular contracture The body, as part of the normal healing process, forms a sheath of connective tissue around the implant. The thickness of this sheath varies from individual to individual, being able to transform in certain people into a true contractile capsule that tightens and deforms the implant, giving the feeling of a "rock-hard" breast. The degrees of encapsulation are variable. The phenomenon of the contractile capsule appears in principle between 6 months postoperatively and 5 years postoperatively, there are also singular cases with the appearance of this type of complication even later but with a very low incidence. Average capsular contracture can yield to antioxidant medication (Vitamin E Forte) and specific antileukotriene (Singulair) and massage, on the other hand, severe capsular contracture requires surgical correction. Surgical reintervention with replacement of the implant and sectioning of the capsule (capsulotomy) or surgical removal of it (capsulectomy) can resolve the situation, but does not prevent recurrences. The deep positioning of the implant under the pectoral muscle presents a low risk of occurrence of the contractile capsule. It is essential to respect the 5-year post-operative follow-up period until the complete stabilization of the implant. The contractile capsule has four grades according to Baker's classification, which are delimited from a clinical point of view: Grade 1- Breast of normal consistency Grade 2- Breast with slightly increased consistency, being stiffer to the touch with a lower degree of mobility Grade 3- Hard, rigid breast, extremely reduced mobility, in some cases the breast begins to deform, it tends to "rise" towards the upper pole, acquiring a fusiform shape Grade 4 - Hard breast, painful to palpation or even continuous, modified shape, advanced towards the upper pole, unsightly shape The evolution of the contractile capsule differs from one patient to another and there is no universal, widely accepted treatment scheme. The contractile capsule represents, in conclusion, a reaction of the body to a foreign body, of an allergic type, the hypotheses being multiple but without incriminating the breast implant, the surgeon or the patient. The contractile capsule diagnosis is made after the clinical examination performed by the doctor in accordance with imaging investigations: ultrasound-elastography, breast MRI. 2. Changes in sensitivity In the postoperative period, there may be changes in the degree of sensitivity of the breast and the areola-nipple area. This can vary from complete numbness to hypo or hypersensitivity associated with qualitative changes in sensations. they can gradually disappear over time. Occasionally, reduction/partial or total loss of skin and nipple sensitivity or increased sensitivity may occur. Changes in sensitivity can affect sex life or breastfeeding. It should be mentioned that vegetarians are exposed to an increased risk of this complication considering the lack of Vitamin B12. 3. Increased skin vascularity The breast region is highly vascularized and in the postoperative period, due to the stretching and thinning of the skin, the superficial veins can become visible and painful - Mondor Syndrome (pain "in the bar" under the breast). This happens especially to very thin people, with poorly represented breast tissue and who want large implants. The pain gives way to the usual painkillers and will disappear in a few weeks. 4. The palpable implant (rippling phenomenon) In the case of thin patients, as a general rule, the larger the implant compared to the dimensions of the existing mammary gland, the greater the risk that its edges will be felt through the skin. The same thing can happen if the patient loses weight after the operation or the BMI is reduced. In any condition, in case of careful and persistent examination of the implanted breast, the prosthesis can be palpated. 5. Rotation of the implant or overturning of the implant It is a very rare complication of the breast implant. It tends to occur in people with strong muscles at the level of the pectoral muscle or in people who do not follow the postoperative indications in the sense of trauma or in the case of ventral decubitus. In the case of a great physical effort (arm pull-ups, push-ups, lifting weights), the adhesions on the chest wall can come off and as a result the implant can go down or rotate. Also, if the patient loses weight and has a large integumentary laxity, rotation or overturning of the implant may occur due to the excessive space. Displacement of the implant, deformations and asymmetries Displacement, rotation or migration of the breast implant from the initial place can occur in some cases and are accompanied by discomfort and/or breast deformation. Some surgical techniques for implant placement may increase the risk of displacement or migration of the implant. Surgical reintervention may be necessary to reposition the implant and correct the asymmetries, but they cannot always be corrected. Due to the characteristics of the tissues and their stretch, the breast implants can descend, they can sag and the nipple can be positioned much higher; the tissues that cover the implant can thin and the implant can become visible and palpable, also the folds produced by the implant (rippling) can be seen. These changes can appear in one or both breasts, they can be different and unequal between the two breasts. 6. Rejection of the implant Scientific research has shown that the material of the implants is compatible with the human body and is not carcinogenic. Very rarely, however, it is possible that the body does not tolerate this implant and it will be necessary to remove or replace it. Also in exceptional cases, extrusion of the implant may occur at the level of the scar. This happens in the case of infections, lack of vascularization at the level of the scar, smokers or large implants. 7. Implant rupture Implant rupture is very rare with a rate of 0.3% - 1% which is considered an extremely low rate. This can occur as a result of a manufacturing defect, stress caused by repeated trauma (electric breast pump), severe trauma (accident, intentional direct hit), treatment of the contractile capsule by external capsulectomy. Implant companies have a breast implant warranty program through which, following the laboratory evaluation of broken implants, they can reimburse the patient for the implant free of charge only if this breakage was caused by a manufacturing defect. The vast majority of ruptures in the case of the latest generation implants with cohesive gel are "silent ruptures" without clinical signs, for this reason the annual ultrasound evaluation and the annual consultation with the attending physician are mandatory. 8. Seroma Represents the accumulation of periprosthetic fluid immediately postoperatively or at a distance that visibly changes the breast, being determined by non-compliance with postoperative indications by performing physical effort at the level of the pectoral muscle or at a distance following a severe trauma, post partum status with the appearance of the phenomenon of post-lactation mastitis or following a severe generalized bacterial or viral infection with changes in inflammation analysis values. The treatment is necessary to evacuate the fluid collection, because it can cause infections, capsular contracture, etc. The treatment is conservative in most cases with antibiotics and anti-inflammatories, and in severe cases it is necessary to drain the fluid accumulation and evaluate it from a bacteriological, immunohistochemical and cytological point of view. In the case of repeated or treatment-resistant seromas, surgical exploration with total capsulectomy is recommended in order to avoid the risk of the occurrence of a very rare lymphoproliferative disease known as anaplastic large cell lymphoma that can also cause intracapsular nodules secreting serosity. A thin layer of periprosthetic fluid is normal and can be found in most patients and is considered normal without pathological values. 9. Chronic pain The degree of postoperative pain and its duration varies from one patient to another and is determined by personal sensitivity as well as the choice of implant size and surgical placement. An implant larger than the anatomical proportions can cause chronic pain, degree IV capsular contracture can also produce a degree of pain. The treatment is medicinal, but in severe cases the need for a minimal surgical exploration can be decided. 10. Soft tissue necrosis and implant extrusion Insufficient tissue coverage of the implant or infection can cause exposure and extrusion of the implant through the skin. Tissue necrosis can occur in the case of corticosteroid treatments, after chemotherapy, local irradiation, smoking. In some cases, the surgical wound/incision does not heal normally. An implant can become visible on the surface of the breast because the implant can be pushed to the surface of the skin. In the event of tissue necrosis, the implant will become exposed, requiring its removal. In these cases, the scar deformity is permanent. It is an extremely rare complication that occurs in cases with a high risk of vascular ischemia. Necrosis of soft tissues can delay the healing of the operation and can cause additional surgical interventions, after which additional scars may appear. Sometimes the implant needs to be removed for a period of 3-6 months. Associated factors that can cause necrosis are: infection, smoking, use of steroids, chemotherapy, post-cancer irradiation. 11. Asymmetry Most women show different degrees of asymmetry of the shape and volume of the breasts preoperatively. Through this operation, these asymmetries can be solved, but not completely, a degree of breast asymmetry will remain, regardless of the technique used. Any postoperative asymmetry in the shape and volume of the breasts or the position of the nipple will require a surgical correction. Asymmetries below 10% between the breasts are considered physiological and do not require additional interventions. In most cases, the two breasts are NOT identical and symmetrical. 12. Stretch marks In extremely rare cases, due to post-augmentation skin expansion, stretch marks may appear on the skin of the breast. 13. Calcifications Calcium deposits/calcifications can form in the fibro-scar tissue around the implant causing pain, tissue solidification and can be visible mammographically/ultrasound. These deposits must be identified and differentiated from breast calcifications from breast cancer. If they appear, surgical intervention for biopsy may be necessary. 14. Deformation of the chest wall It can appear secondary to breast augmentation, without important consequences. 15. Contamination of the implant surface with various substances used during surgery has unknown consequences. 16. Rejection of suture materials The vast majority of patients absorb the intradermal suture threads for a period of 6 months postoperatively without any skin rejection reaction. In certain cases based on allergic type sensitivity, thinning of the fat layer due to weight loss, etc., some patients reject non-absorbable threads from deep and it is necessary to surgically cure them superficially, a fact that sometimes causes a vicious scar that can be treated later. 17. Breast Implant-Associated Anaplastic Large Cell Lymphoma I understand that breast implants are associated with the development of a type of immune system cancer called Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). This type of cancer is not a form of breast cancer. Current scientific data collected and published show that there is a risk between 1 in 2596 and 1 in 30000 patients, depending on the type of implant and its texture. This type of cancer has been reported in the vast majority of textured breast implants, especially those with a high degree of texturing and those with polyurethane, but cases have also been reported with microtextured and smooth ones. In the case of smooth implants, there is currently no case with a strict history (patient who has never had a textured implant in her body), but this fact does not ensure that no cases will be discovered in the future. Patients with breast implants have a higher risk of developing BIA-ALCL at the level of the capsule (scar tissue around the implant) and at the level of fluid (serum) around the implant. Usually the development of BIA-ALCL requires several years to appear (approximately 7-9 years after implantation), but there have also been cases reported after one year after implantation. Typical symptoms include: breast swelling, breast tension, pain, intracapsular nodules, or fluid accumulation around the implant, months or years after breast implant surgery. The treatment of BIA-ALCL requires a surgical intervention in which the breast implants and the scar tissue surrounding the breast implant are extracted. Depending on the stage of the disease, certain patients may need chemotherapy and radiotherapy or more extensive surgical interventions. The initial stages of the disease require only surgical treatment. Although BIA-ALCL responds well to treatment, there are a small number of patients, usually in advanced stages, who have died from this disease. ADDITIONAL INFORMATION Breastfeeding Most women who have undergone breast augmentation can breastfeed. There is no known increase in the risk of caring for women with breast implants. Following the studies carried out, there was no evidence of an increase in the concentration of silicone in the breast milk of women with breast implants. Periareolar implant placement surgical techniques may reduce the ability to breastfeed. Breast cancer Scientific studies have not demonstrated a higher incidence of breast cancer in women who have breast implants compared to those without implants. It is recommended that all women do a periodic breast examination, including ultrasound/mammography. Special attention must be paid during breast biopsy in women with breast implants to avoid damaging them. Mammography is difficult to perform in women who have breast implants, breast implants can mask a possible breast cancer. Implant rupture can occur through breast compression during mammography. Women who have breast implants must inform the specialist about the presence of the implants. Ultrasound and MRI can evaluate the condition of the breast and implants. Long-term results Subsequent changes in the shape of the breast may occur due to aging, changes in body weight, pregnancy or other conditions unrelated to breast augmentation. Breast ptosis (breast drooping) can occur over time. Unsatisfactory results Patients may be dissatisfied with the result of the breast augmentation intervention. Asymmetry in the placement of implants, their displacement, changes in the position of the nipple, the unpredictability of the shape, volume and size of the breasts can occur postoperatively. Unsatisfactory placement of postoperative scars may occur. Re-surgical intervention may be necessary to improve the result or remove the implants. Removal / repositioning of breast implants Subsequent revision, removal or repositioning of breast implants and fibro-scar tissue around the implants involves surgical procedures with associated risk and complications. Autoimmune diseases No correlation has been demonstrated between the presence of breast implants and the occurrence of autoimmune diseases (lupus erythematosus, rheumatoid arthritis, scleroderma, etc.) Breast augmentation surgery is NOT necessary, it is performed at the request of the patient. Its result is NOT permanent. It is NOT perfect. It may require subsequent "revisions" in weak patients. the implant is visible, palpable and the rippling can be noticed (the "folds" of the implant can be seen) Smokers have a increased risk of delayed healing and tissue necrosis. ADDITIONAL COSTS Considering that Dr. Paul Nistor cannot predict and has no control over the characteristics of the tissues, over the healing process and the result of the breast augmentation surgery, I understand and accept that any complications may occur, and in the event that reoperations are necessary to improve them, they are personally responsible for all costs associated with these surgical reinterventions; these involve the correction of: displacements, deformations, migration of implants, asymmetries, exaggerated lowering ("sagging") of implants, breast ptosis ("sagging" breasts), abnormal positioning (too high, too low, too lateral, etc.) of the nipple Distances that are too large between the two breasts Thinning of the tissues that cover the implant which makes the implant visible, palpable Visible wrinkles (rippling) in any region of the breasts due to the traction exerted by the implant on the tissues Capsular contractures, hardening of the breasts / implants Pain or discomfort in the breasts / chest Delayed healing, wound dehiscence (reopening of the surgical wound), scars Change in skin and nipple sensitivity Disturbances in lymphatic circulation (enlargement of lymph nodes, appearance of lymphatic cords) MANDATORY POSTOPERATIVE INDICATIONS 1. They are prohibited for a period of 45 days trauma to the breasts. 2. It is forbidden for a period of 45 days to raise (raise) the elbow above the level of the shoulder 3. It is forbidden for a period of 45 days to lift a weight over 3.5 kg 4. It is forbidden for a period of 60 days to exercise any nature 5. It is mandatory to wear the medical bra for 90 days non-stop, later at night for the entire duration of maintaining the breast implants. 6. It is mandatory for a period of 30 days to sleep in a dorsal decubitus (on the back), and for up to 6 months in a lateral decubitus (on one side) being forbidden to sleep in a ventral decubitus (on the stomach) until then 7. For 4 in the postoperative months, intense physical effort on the pectoral muscles is not recommended (pull-ups, push-ups, tennis, performance swimming, etc.) 8. For a degree of stability and reliability for a long postoperative period of weight variations of maximum +/- 3kg are recommended for breast implants, and during pregnancy and breastfeeding a maximum excess weight of 9-12 kg according to the indications of the gynecologist 9. Regular check-ups at +40 747 806 422 days, +40 747 806 422 months and annually the first five years are mandatory and will ensure the correct medical follow-up in the postoperative evolution, avoiding many of remote complications that may occur after this operation. An annual breast ultrasound evaluation is mandatory and you must have it at each annual post-operative check-up. Also, the post-operative visit card must be signed at each post-operative visit. 10. Smoking is a major risk factor on the postoperative outcome, having important implications in the occurrence of complications such as: hematoma, postoperative bleeding, wound dehiscence, defective healing, defective scarring, tissue necrosis. For this reason, we recommend stopping smoking at least 1 month preoperatively and another 3 months postoperatively. By signing this agreement, you allow the doctor and his collaborators to collect saliva samples during periodic checks for the nicotine test (Cotinine test). If the test is positive or the patient refuses to take the samples (it is considered a positive test), the doctor declines any responsibility for the aesthetic result and the inherent complications, the patient assuming full responsibility, a fact that determines additional costs if interventions are required and additional medical treatment. Failure to comply with postoperative indications can lead to unwanted complications and at the same time exonerates the doctor, the clinic and the hospital from any fault, being the patient's personal responsibility by assuming them, a fact that determines additional costs for the patient in case of a complication or degree of dissatisfaction determined by the refusal to comply with the instructions. 11. It is mandatory to treat postoperative scars with specific creams in this regard, in order to obtain a supple and integrated scar. This treatment starts one month postoperatively for a period of 8 months. Also, in the first postoperative year, it is forbidden to expose the scars to UV radiation, as there is a risk of their hyperpigmentation (brown coloration of the scar). In this sense, in the case of exposure to the sun, the scars must be very well covered. DEGREE OF SATISFACTION AND DURATION OF THE OBTAINED RESULT The patient's degree of satisfaction depends on a multitude of factors. Realistic preoperative expectations, knowledge and acceptance of risks and consequences are the best predictive factors for a successful operation. Breast implants are measured in volumes (cc or grams) not in cups and therefore you cannot be guaranteed a certain cup size postoperatively. The purpose of the operation is to obtain a volume of the breasts proportional to the dimensions of the body, to the height and weight of the individual. Also, the final position of the implant (level, height) and its shape depend on the type of implant chosen. The slight preoperative asymmetry of the breasts including the projection and position of the areola-nipple complex can be accentuated postoperatively. The slight asymmetry that most women present cannot be corrected by breast implant surgery, just as the breasts can neither be raised nor brought closer by this intervention. To achieve this effect, you can use a suitable bra. The duration and maintenance of the obtained result are NOT guaranteed for life. The breast, like any other organ of the body, undergoes changes with the aging process, which may consist of changes in shape and size obtained postoperatively. The extent of these changes is influenced by a number of factors: weight variations, hormonal changes, pregnancy, breastfeeding, stress, local glandular changes (contraction of breast tissue due to circulatory disorders). Postoperatively, each patient will receive a breast implant guarantee, which is strictly a guarantee of the breast implant and not of the operation itself. Breast implants are NOT guaranteed for life. It is recommended that after the operation the body weight is kept constant and therefore any slimming cure will be kept before the operation. It is also recommended not to get pregnant for at least 6 months after the operation. The previous points were fully explained to me, clarified during the initial medical consultation, I understand them, accept and sign and I am aware that any of the complications listed above may occur, as it is a surgical intervention. Analysis of the patient's appearance Factors with a low probability of modification or correction after performing the breast augmentation intervention S / R breast larger - the breasts will never be identical S / R nipple-areola positioned higher - the position will not be able to be perfectly corrected The inframammary fold S / R positioned higher – the position will not be able to be perfectly corrected The position of the nipple differs from one breast to another and will not be able to be perfectly corrected The distance between breasts can only be slightly reduced, still leaving a space of _______ cm. There is an asymmetry of the chest walls that cannot be corrected and will change the shape of the breast The overall position of the breast on the chest wall will not change. If one inframammary fold is positioned lower than the other, it will keep its position even after the intervention. The basic shape and configuration of the breasts will remain the same, they will not change spectacularly, what changes is only the size. above. ____________________________ Dr. Paul Nistor studied my photographs in detail. I have seen, understood and accept all the above factors, which will not change or which may only partially improve after breast augmentation. I fully understand and accept the fact that my breasts cannot be identical, just as their details cannot be identical, and that what I must aim for is not perfection but only the improvement of their size.
