Cohesive Silicone Gel-Filled Breast Implants

Transcription

1 Cohesive Silicone Gel-Filled Breast Implants 1023

2 Descriptions UNIGEL, Cohesive gel-filled breast Implants are designed for use in cosmetic augmentation mammaplasty or reconstruction of the breast. The silicone elastomer shell may be produced smooth or textured surface to offer a disruptive contact surface for collagen interface and the gel may be a very soft cohesive gel or a firm cohesive gel. UNIGEL is a silicone gel-filled breast implant made with a micro-structured silicone envelope. The silicone envelope consists of implant grade high performance silicone elastomer with an integral surface microstructure that exhibits greater resistance to tear propagation than conventional silicone rubber. High performance silicone barrier layer is laminated in the inner surface of the envelope to provide an effective barrier that significantly minimizes gel bleed. The envelope is filled with transparent silicone gel. This implant is available in a range of product sizes, providing the surgeon with versatility in satisfying specific patient requirements. Except for special order products, the unit volume in cc s implant style. UNIGEL Round Type STYLE ROUND, SMOOTH STYLE ROUND, TEXTURE STYLE PROFILE Low, Moderate, High, Ultra-High Profile Low, Moderate, High, Ultra-High Profile RANGE 100cc~700cc 100cc~700cc A B A : Diameter B : Projection UNIGEL -1-

3 UNIGEL Anatomical Type STYLE ANATOMICAL STYLE PROFILE Low, Medium, Full Height RANGE Low, Moderate, High Profile Demonstrates inadequate or unsuitable tissue; e.g. radiation damage to tissue, ulceration, or has a history of compromised wound healing. May experience compromised vascularization because of implant placement. Demonstrates physiologic or anatomic anomalies that might result in significant post-operative complications. Insufficient tissue covering due to radiation damage on the chest wall, tight thoracic skin grafts or radical resection of the pectoralis major muscle History of augmentation/reconstruction Physiologically/Psychologically unsuitable patient Any other serious medical condition Has an active infection. C A B A : Width B : Projection C : Height Indications Cosmetic augmentation surgery Augmentation and contour correction of congenital anomalies of the breast Reconstruction of the breast following subcutaneous mastectomy and other suitable mastectomy procedures or trauma Combined breast and chest wall abnormalities Replacement of implants for medical and cosmetic reasons Precautions It is the responsibility of the surgeon to inform potential patients or their representatives, prior to surgery, of the possible complications associated with the use of this product. Pre-existing infection should be treated and resolved before implantation of the implant. The surgical approach and incision size should be evaluated by the surgeon in line with the stresses which will be placed on the implant. Certain surgical approaches may result in higher stresses on the implant during insertion and may result in more difficult insertion of the implant. The surgeon should select an incision size and location which allow for creation of a welldefined, dry pocket; allow for insertion of the implant without distortion; and allow for ready digital access to the pocket to ensure flat implant placement and smoothing of the implant surface. Product should be visually examined for any evidence of particulate contamination, damage or leakage. The implant should be kept submerged in sterile water or normal saline prior to implantation to prevent contact with airborne and surgical field particulate contaminants. The breast implants may contain air bubbles. This occurs normally during sterilization and has no effect on product integrity or performance. Contraindications The use of these implants is contraindicated in patients who have one or more of the following conditions: Fibrocystic disease Existing local or metastatic carcinoma of the breast Recent history of breast abscess Has a history of immunological responses or sensitization to foreign materials. Demonstrates psychological instability, displays a lack of understanding, or inappropriate motivation or attitude. Is not willing to accept the possibility of multiple surgeries for revision. Care must be taken to prevent surface contaminants such as talc, dust and skin oils from coming into contact with the implant. Products should be inspected for contamination prior to insertion. Contamination at the time of surgery increases the risk of periprosthetic infection, and possibly capsular contracture. Textured silicone surfaces are potentially more susceptible to contamination than smooth silicone surfaces. Extra care should be taken in the handling of textured surface implants and SEWOON MEDICAL accepts no liability for products contaminated by other substances after the product leaves our possession. Surface contaminants (talcs, dust, lint, oils) on surface of implants can cause foreign body reaction, handle with care with surgical gloves (rinsed free of talc) with strict aseptic technique. Do not implant contaminated product. Back-up Implant must be readily available at the time of surgery for use in the event of contamination. The surgeon should select an implant size, implant style, pocket location, and pocket size appropriate for the patient frame size UNIGEL -2- UNIGEL -3-

4 (i.e. the implant diameter is not too large for the breast and chest wall dimensions) and tissue coverage (especially when there is a limited breast tissue coverage and/or limited subcutaneous fat). The submuscular plane may be preferable in patients with minimal, thin, and/or poor quality overlying tissue. The pocket size created by the surgeon should be of sufficient size to allow the implant to lie flat in the pocket. Implant Life Expectancy: It is not possible to predict the life expectancy of an implanted breast Implant. Performance of the implanted Implant is not related solely to the design,materials of composition or fabrication of the Implant, but also relates to the surgical procedure with its possible attendant medical complications and consequences and to the specific medical condition, physiological, anatomical, biological and behavioral aspects of the patient. Most patients have had implants with no revisions, others have required multiple revisions. minimize the risk of damage. Does not endorse or recommend the introduction of drugs around the implant. The action of drugs, such as vitamins, anti-inflammatory steroids, and antibiotics, in conjunction with the breast implant has not been adequately tested by the manufacturer. The risks of such usage are unknown. Does not introduce or make injections of drugs or other materials into the implant. Injections through the implant shell will compromise the product integrity. Incidents of tissue necrosis and skin erosion with subsequent exposure or extrusion of the implant have been reported following microwave diathermy of patients with gel-filled implants. Therefore, The use of Microwave diathermy in patients with breast Implant is not recommended. The silicone gel breast Implant should be implanted without any alterations to its original design or fabrication. Warnings It is the surgeon s responsibility to make a medical assessment as to patient suitability for implantation, and to decide the surgical technique suitable to both the patient and the chosen implant type and design. Breast implant surgery is known to provide psychological satisfaction to patients, but like any surgical procedure it can have potential complications and risks. Breast im plantation is an elective procedure and the patient should be well counseled on the risk/benefit relationship, by the surgeon. Each of the possible complications and warnings should be discussed with the patient prior to the decision to proceed with surgery. The possibility of explant surgery taking place at any time after implantation should also be used with the patient. Patients should be informed that breast implants should not be considered as lifetime implants due to potential individual physiological reactions, inherent nature of silicone implant designs and various implant procedures. Extreme care should be taken in the use and handling of implants to minimize the potential for breakage of shells. All implants have been produced by established manufacturing techniques and under strict quality control standards, but there will be some breakage of implants during handling or in surgery, both in initial and any subsequent surgeries. Utmost care must be taken to avoid contact with sharp objects, such as surgical instruments, suture needles or hypodermic needles. Avoid undue handling with blunt instruments or manipulation. Implants should be carefully inspected for structural integrity prior to use. Meticulous care must be taken to avoid pinching the Implant with instruments and avoid contacting the implant shell with any sharp or pointed objects such as needles or surgical instruments. Any cut, puncture, scratch, or other compromise of the envelope integrity, whether inadvertent or intentional, will expose the silicone gel and will render the implant unusable. If the implant should accidentally rupture during insertion or be nicked with an instrument or suture needle, remove the damaged implant and any exposed gel and replace with a new, intact, sterile implant. A surface scratch or partial penetration in the shell may be enough to eventually cause subsequent rupture. Damaged products should not be implanted, do not attempt to repair damaged products. If an implant is accidentally ruptured during placement, utilize a new back-up implant. Recommended procedures for testing, examination and handling of products should be meticulously followed to assure proper use of implants. Patients should be instructed to inform other treating physicians of the presence of implants to Placing a foreign object in the body can cause sepsis, hemorrhage or thrombosis. Do not try to repair the implant or leave it in the surgical pocket. When inserting and positioning the implant, care should be taken to ensure the unit is flat with a minimum of surface wrinkling and to avoid excessive manipulation or undue handling with sharp, pointed or blunt objects, including retractors. Avoid extensive stretching of the envelope during insertion as it may result in a local bulge in the implant shell. When the surgeon treats a hematoma or serous fluid accumulation by aspiration, or performs a biopsy, care should be taken to avoid damaging the implant. These procedures present possible risk of implant puncture. The American College of Radiology has stated that mammography may be more difficult to perform and less effective on implanted breasts. It is preferred that the mammographer has experience with the most current radiological techniques and equipment for implanted patients. This will increase the cost as well as increase the radiation exposure to the patient. All patients should be provided this information and be advised to inform referral physicians and radiographers of the presence of an implant. Dispose of material in accordance with all the state, local, and hospital regulations. Responsibility for proper waste disposal is with the owner of the waste. Adverse Reaction and Complications The potential complications associated with all surgical procedures should be discussed with the patient. These include but are not limited to: infection(see below); hematoma(see below); serous fluid accumulation(see below); loss of sensation(see below); reaction to medication; nerve damage; patient intolerance to any foreign implant; and poor wound healing. Thousands of women per year have cosmetic or reconstructive surgery with implantation of breast Implants. UNIGEL -4- UNIGEL -5-

5 Complications or adverse reactions have been reported. Any patient undergoing a surgical procedure is subject to intraoperative and post-operative complications. Each patient s tolerance to surgery, medication, and implantation of a foreign object may be different. Possible risks, adverse reactions and complications associated with surgery and the use of the breast Implant should be discussed with and understood by the patient prior to surgery. The adverse reactions and complications most likely to occur with the use of this product are listed below. It is the responsibility of the surgeon to provide the patient with this information prior to surgery. UNIGEL is composed of alloplastic materials. Therefore, it is subject to possible reactions and complications including those listed herein. The patient should not be led to unrealistic expectations as to the performance or cosmetic results that the surgery and implant can provide. The patient should be informed that the life expectancy of any implant is unpredictable, and that successful results cannot be guaranteed. Asymmetry Asymmetry may be attributed to pre-existing anatomic asymmetry, incorrect choice of implant shape or size, surgical technique, contracture of the fibrous capsule, seroma or hematoma, breast dysplasia developing post-operatively, discrepancy in muscle development between sides. Asymmetry may result from improper initial placement, displacement, or failure to correct pre-existing asymmetry through variation in individual implant size. Pre-existing asymmetry may not be entirely correctable. Asymmetry may also be a symptom of capsular contracture, fluid accumulation, infection, post-operative breast dysplasia, unilateral discrepancy in muscle development, or deflation, requiring further investigation. In the event of rupture of an implant, it is recommended that the implant be removed promptly. Ptotic Breast It is possible that, like the non-augmented breast, the augmented breast may become ptotic over time. Variability in skin elasticity and muscle tone may contribute to this result. Breast and Nipple/Areola Sensation It is reported in the medical literature that some patients undergoing breast surgery experience a significant decrease in sensation or hypersensitivity of their nipple/areola complex, and less frequently, the breast area in general. The risk of neurological impairment increases with more extensive surgery. With more extensive breast surgery there is a greater possibility that the patient will experience changes in sensation to breast skin and/or nipple complex. The return of sensation varies among patients. In a few instances, it has taken as long as several years for sensation to return. There are also reports of permanent loss of nipple or breast sensation. Pain Breast region pain of varying intensity and duration has been reported as an expected occurrence following breast implant surgery. In addition, there have been reports of pain in association with excessive capsule contracture. Infection When infection is associated with an implant site, an appropriate regimen of treatment should begin. If an infection is encountered and not brought under control, it is recommended that the implant be removed. Occasional latent infections of unknown etiology have also been reported. A specific infection-related event, Toxic Shock Syndrome, has been referenced, or speculated upon, in rare case reports involving breast implant implantation. Preexisting infection not resolved before implant placement increases the risk of periprosthetic infection. Do not expose the implant to contaminants, which increases the risk of infection. Infection is an inherent risk following any type of invasive surgery. Infection around a breast implant may occur within days, weeks, or even years, after surgery. Signs of acute infection reported in association with breast implants include erythema, tenderness, fluid accumulation, pain and fever. Signs of subclinicalinfection may be difficult to detect. Postoperative infections should be treated aggressively according to standard medical practices to avoid more serious complications. Infection that is unresponsive to treatment or necrotizing infection may require implant removal. Capsular contracture may be related to infection in the area surrounding the implant. Haematoma/Seroma Haematoma are complications associated with any type of invasive surgery. Postoperative haematoma and seroma may contribute to infection and/or capsular contracture. Postoperative haematoma and seroma may be minimized by meticulous attention to haemostasis during surgery and also possibly by postoperative use of a closed drainage system. Persistent, excessive bleeding must be controlled before the device is implanted. Any postoperative evacuation of haematoma or seroma must be conducted with care to avoid contamination or damage to the implant. Serous Fluid Accumulation Serous fluid accumulation occurs occasionally in association with the surgical placement of any breast implant and may be accompanied by swelling and pain at the surgical site. This condition is reported to occur more frequently with surfacetextured implants as a part of a normal wound healing in response to a non-smooth surface. This condition may also occur as the result of trauma. If aspiration is the surgeon s treatment of choice, every precaution should be taken not to damage the implant. This procedure presents possible risk of implant puncture. Prolonged persistent serous fluid accumulation may necessitate removal of the implant. Immune Responses There have been reports of suspected immunological responses to silicone breast implants. Many of the case reports suggest systemic illness with joint pain, myositis, fever, and lymphadenopathy being most frequently mentioned. Additional symptoms claimed include, for example, localized inflammation and irritation at the implant area, fluid accumulation, rash, general malaise, swelling of joints, weight loss, scleroderma, chronic arthropathy, morphea, keratoconjunctivitis sicca, pyrexia, skin lesions, arthralgia, and alopecia. Some reports in the medical literature refer to various combinations of such symptoms as so-called silicone-induced human adjuvant disease. A review of the published experimental findings and clinical experience shows that convincing evidence does not exist to support a causal relationship between exposure to silicone materials and the acquisition or exacerbation of a variety of rheumatic and connective tissue disorders. A causal relationship between breast UNIGEL -6- UNIGEL -7-

6 implants and rheumatic/ connective tissue disorders such as scleroderma, scleroderma-like disorders, and other rheumatic/ connective tissue disorders remains to be established. If an immunological response is suspected and the response persists, removal of the implant is recommended along with removal of the surrounding capsule tissue. Such patients should not be reimplanted. Interruption of Wound Healing/Extrusion of Implant Causes cited include infection, fluid accumulation and lack of drainage, hematoma, too tight a closure, too large an implant for the pocket, contamination of suture line, abscess of sutures, improper support, pressure against the wound, i.e. improperly fitted wired brassiere, trauma, use of anti-inflammatory steroids in the pocket, placement of the implant in injured areas (i.e. burned, irradiated, scarred tissue). Exposure or extrusion of the implant may occur. Unstable or compromised tissue covering and/or interruption of wound healing may result in exposure and extrusion of the implant. Causes or contributing factors may include infection, wound dehiscence, necrosis with or without infection, capsular contracture, closed capsulotomy, unsuitable skin flap, improper size and placement of implant, and/or tissue erosion associated with implant folds. The incidence of extrusion has been shown to increase when the implant has been placed in injured areas: scarred, heavily irradiated or burned tissue or crushed bone areas; where severe surgical reduction of the area has been performed; and where steroids are used in surgical pocket. Skin Sloughing/Necrosis Skin breakdown may be attributed to inadequate circulation due to thinness of the skin flap overlying the implant or too large an implant relative to the pocket size. It may also be attributed to trauma to the skin intra-operatively, the use of anti-inflammatory steroids, or skin deterioration or breakdown. Implant exposure and/or extrusion may result. Unresolved skin breakdown may necessitate removal of the implant. Early compromise in skin circulation necessitating post-operative implant removal has been reported in the medical literature where subcutaneous placement of the implant was used for reconstruction of congenital amastia, subcutaneous mastectomy, and cancer mastectomy. Palpability Palpable implants have been reported by some surgeons. It may be more readily observed in a patient with a large implant relative to pocket and/or patient frame size, when there is thin or tight overlying tissue, when the implant is placed in the subcutaneous position, and/or when contracture occurs. Reported causative factors of capsular contracture include infection, haematoma, lack of drainage, implant volume, diabetes mellitus, patient s immune system, implant type, gel bleed, trauma, foreign body reaction, inadequate pocket dissection, and implant placement. The medical literature documents that correction may require surgical intervention. In some patients, even with further surgery and treatment by their surgeon, breast firmness may recur. Integrity of the implant envelope cannot be assured if the surgeon should choose to perform closed capsulotomy because unknown or abnormal force will be applied to the implant. Such abnormal trauma or stress to the breasts could result in implant rupture with extravasation of gel into surrounding tissue. The chance of excessive capsular contracture for all augmented patients will increase with time and may necessitate reoperation. Patients who have undergone reconstructive breast surgery stand a high chance of the need for reoperation at some future date to correct excessive capsular contracture. Fibrous capsular contracture is a common complication following breast implant surgery. While formation of a fibrous tissue capsule surrounding the implant is a normal physiological response to a foreign body, not all capsules contract. Contracture of the fibrous capsular tissue surrounding the implant may result in firmness, discomfort or pain in the breast, distortion of the breast, palpability of the implant, or displacement of the implant. The etiology of capsular contracture is unknown, but is most likely multifactorial. Contracture develops to varying degrees, unilaterally or bilaterally, and may occur within weeks to years after surgery. Severe cases may require surgical intervention. Capsular contracture may recur after capsulotomy or capsulectomy. Lumps perceived as capsular scarring have delayed the diagnosis of palpable tumour. Questionable lumps must be promptly investigated. Tumorigenesis During the past 28 years of clinical use, the medical literature generally indicates that the silicone breast implant is not tumorigenic. There have been case reports or ordinary breast cancer associated with the presence of breast implants, as would be expected on statistical grounds alone. This study of over 3,100 subjects concluded that the incidence of ordinary breast cancer in women with breast implants is no greater than statistically expected for that population. No cancers of the breast other than carcinomas were found. Malignant sarcomas in animals (rats) associated with implanted silicone gel are to be expected on the basis of solid-state tumorigenesis or the so-called Oppenheimer effect which applies to all relatively stable alloplastic materials. Available evidence demonstrates that the induction of sarcomas (solid-state tumorigenesis) as seen in animals either does not operate in man or is, at most, a rare event. There is no evidence that silicone materials can induce breast malignancies of any type. Additional Informations Capsule Formation and Contracture The post-operative formation of a fibrous tissue capsule around the breast implant is a normal physiologic response to the implantation of a foreign object. Capsule formation occurs in all patients. However, each patient s capsule will vary in degree, ranging from thin to heavily thickened. Contracture of a fibrous capsule may occur, independent of its thickness, resulting in discomfort, pain, excessive breast firmness, a palpable implant, wrinkles and/or folds in the implant shell, and/or displacement of the implant. The presence and degree of capsular contracture may effect the diagnostic value of mammographic procedures. Rupture Rupture can occur post-operatively from damage to the implant during handling or surgery. Rupture of the shell can also occur from contracture, intra- and post-surgical trauma, excessive stress or manipulation and purposeful or accidental trauma as in vigorous exercise, athletics, and intimate physical contact; mechanical damage before or during surgery, or other unknown causes at the site of implantation, including so called spontaneous rupture. Excessive manipulation of the implant shell during use as may be experienced during the performance of routine manual massage or manual exercise of the implanted breast may also produce long-term fatigue of the envelope, resulting in rupture. If the surgeon should choose to UNIGEL -8- UNIGEL -9-

7 perform manual compression of the breast (closed capsulotomy), he/she should be aware that it may lead to implant rupture due to weakening of the envelope from the forces the implant may experience. The patient should be adequately informed of the possibility of implant rupture with the use of this technique and of the necessity to remove a ruptured implant. SEWOON MEDICAL is not responsible for the integrity of the implant if a closed capsulotomy is performed. Because of the cohesiveness of the gel material, some gel ruptures can go undetected unless surgery occurs for another reason (e.g. size exchange). Despite the cohesive properties of the gel, extravasation out of the surgical pocket can occur under pressure, in which case additional surgery may be required to retrieve the gel. Inflammation and formation of silicone granulomas have been reported. If shell rupture is suspected, the implant should be removed. Calcification(Calcium Deposits) Physicians have reported so-called calcification of the tissue surrounding the implant. This mineralization is referred to in the medical literature as heterotopic ossification. The etiology of calcification is unclear. In some instances, heavy calcification resulting in local discomfort and breast firmness may require removal of the implant and the calcified capsule. Calcification commonly occurs in mature breast tissue with or without implantation. Calcification is also known to occur after implantation of a foreign body, although the etiology is unknown, and reported cases are rare. Microcalcification after implantation typically occurs on or around the fibrous capsule in thin plaques or accumulations. Extensive microcalcification may cause breast hardness and discomfort, and may necessitate surgical intervention. Gel Bleed Gel bleed is the passage of small quantities of silicone through the elastomeric shell of the implant. In vitro bleed tests demonstrate that this bleed phenomenon is significantly reduced in the UNIGEL. As a result, the envelopes of the implants will be relatively dry feeling. The detection of small quantities of silicone in the tissue adjacent to the intact, conventional gelfilled implant and detection of small quantities of silicone in axillary lymph nodes has been reported in the medical literature. Some cellular reaction around the implant may be expected as a normal foreign body response. Some doctors believe that silicone bleed from breast implants may appear in breast milk. However, a study reported to the medical community indicates that milk samples from implanted and non-implanted mothers show no difference in silicone content. Wrinkles, Folds, or Knuckles In Implant Shell Some surgeons have indicated that in some patients wrinkles, folds, and/or knuckles in the implant shell may occur and be visible and/or palpable beneath the overlying tissue. Wrinkles and/or folds are a possible clinical outcome, especially if one or more of the following conditions exist: The patient is thin (i.e. little or no subcutaneous fat) or is small-framed. There is no breast tissue or breast tissue is sparse. The overlying tissue is of poor quality, e.g. a postpartum patient with slack, less elastic skin or a mastectomy reconstruction patient. The implant is placed in the subcutaneous position. The implant is of generous base dimensions and volume relative to the patient s frame size and size of the pocket which is created. Wrinkles or a rippling of the implant shell may be most commonly seen in the infraclavicular region. Folds with associated knuckles at the ends of the folds are most commonly reported in the lateral to medial inferior region of the implanted breast but may also be observed in the other regions as well. Surgical revision may be desired by some patients exhibiting wrinkles or folds. For some patients, these features have been reported to diminish with time. There have been reports of folds leading to thinning and erosion of the overlying tissue. In such cases, implant removal will likely be required. Thin or inadequate overlying tissue, patients with little or no subcutaneous fat, implants which are too large for the surgical pocket or the anatomical structure of the patient, and subcutaneous placement may contribute to palpable, or visible, wrinkles and folds. Folds may result in thinning and erosion of adjacent tissue and erosion of the implant. Signs of skin inflammation, such as tenderness and erythema, may indicate thinning or erosion and must be promptly investigated. Palpable wrinkling and/or folds may be confused with palpable tumour, and questionable cases must be promptly investigated. Interference with Mammography Standard positioning techniques have shown significant limitations when used for imaging augmented breasts. The implant can interfere with the detection of early breast cancer through mammography by obscuring some underlying breast tissue and/or by compressing overlying tissue which can hide suspicious lesions in the breast. Patients should be instructed to request radiologists who are experienced with the most current radiological techniques and equipment for imaging breasts with implants, and to inform their radiologists of the presence, type, and placement of implants. Dissatisfaction with Results The complications of incorrect size, misplaced scar location, hypertrophic scarring and those listed below are usually related to surgical technique. Careful size selection, creation of an appropriate and adequate size surgical pocket, and use of current accepted surgical procedures are the surgeons responsibility. Displacement or Explantation of Implants Implants may displace with accompanying discomfort and/or distortion in breast shape. Difficult placement techniques may increase the risk of displacement by reducing pocket size and placement accuracy. Displacement may require surgical intervention. Although there are no definite reports in the medical literature, it is anticipated that a large number of breast implants will be surgically explanted or replaced. This is not unlike many other plastic surgery procedures which are commonly repeated to maintain patient satisfaction. Due to the wide variety of patients physical responses to breast implant surgery, differences in surgical techniques and medical treatments, as well as potential complications, patients should be advised that these should not be considered lifetime implants and explant surgery may be indicated at any time. SEWOON MEDICAL makes no representations for the term of implantation of the device. Connective Tissue Disease (CTD) Connective tissue diseases include diseases such as lupus, scleroderma, and rheumatoid arthritis. There have been a number of published epidemiological studies which have looked at whether having a breast implant is associated with having a typical or defined connective tissue disease. The most recent of these concluded that the weight of the evidence did not support causal association between implants and definite or atypical CTD. The study size needed to conclusively rule out a smaller risk of connective tissue disease ( 2) would need to be very large. Published studies taken together show that breast implants are not significantly associated with a risk of developing a specific CTD. These studies do not distinguish between women with intact and ruptured implants. Only one study evaluated specific CTD diagnoses and symptoms in women with silent ruptured versus intact implants, but the study was too small to rule out a small risk. Cancer Breast Cancer Reports in the medical literature indicate that patients with breast implants are not at a greater risk than those without breast implants for developing breast cancer. Some reports have suggested that breast implants may interfere with or delay breast cancer detection by mammography and/or biopsy; however, other reports in the published medical literature indicate that UNIGEL -10- UNIGEL -11-

8 breast implants neither significantly delay breast cancer detection nor adversely affect survival of women with breast cancer. A large follow-up study reported no evidence of an association between breast implants and cancer, and even showed a decreased incidence of breast cancer compared to the general population. Brain cancer One recent study has reported an increased incidence of brain cancer in women with breast implants as compared to the general population. The incidence of brain cancer, however, was not significantly increased in women with breast implants when compared to women who had other plastic surgeries. A recently published review of four large studies of women with cosmetic implants and an additional long-term follow-up study concluded that the evidence does not support an association between brain cancer and breast implants. Respiratory / lung cancer Studies have reported an increased incidence of respiratory/ lung cancer in women with breast implants. Other studies of women in Sweden and Denmark have found that women who get breast implants are more likely to be current smokers than women who get breast reduction surgery or other types of cosmetic surgery. Cervical / vulvar cancer One study has reported an increased incidence of cervical / vulvar cancer in women with breast implants, while another long-term study showed equivalent incidences of cervical cancer in women with breast implants compared to the general population. Other cancers One study has reported an increased incidence of stomach cancer and leukemia in women with breast implants compared to the general population. This increase was not significant when compared to women who had other types of plastic surgeries. Lymphomas, including anaplastic large T-cell lymphoma (ALCL) Information from the medical literature has suggested a possible association, without evidence of causation, between breast implants and the very rare occurrence of ALCL in the breast. This disease is exceptionally rare and occurs in women with and without breast implants. Specific testing is needed to identify ALCL from other cancers of the breast. It is important to note that these findings are considered preliminary. The majority of the cases reported in patients with breast implants present as late occurring seromas and have an indolent clinical course, including some involving spontaneous remission without adjuvant therapy. No study has concluded a cause and effect relationship between ALCL and breast implants. Physicians should keep abreast of ALCL in the literature and provide appropriate therapy to patients as needed. Neurological Some women with breast implants have complained of neurological symptoms (such as difficulties with vision, sensation, muscle strength, walking, balance, thinking or remembering things) or diseases (such as multiple sclerosis), which they believe are related to their implants. A scientific expert panel report found that the evidence for a neurological disease or syndrome caused by or associated with breast implants is insufficient or flawed. Further review of the epidemiologic evidence also failed to find an association between implants and neurologic disease. Mental Health Disorders Patients should be encouraged to discuss any history of mental health disorders, including a clinical diagnosis of depression, body dysmorphic disorder or eating disorder with you during their consultation visit(s). Patients with a diagnosis of depression or other mental health disorder should be encouraged to wait to schedule surgery until these conditions resolve. Suicide In several studies, a higher incidence of suicide was observed in women with breast implants. The reason for the observed increase is unknown, but it was found that women with breast implants had higher rates of hospital admission due to psychiatric causes prior to surgery, as compared with women who had breast reduction or in the general population of Danish women. Effects on Children At this time, it is not known if a small amount of silicone may pass through from the breast implant silicone shell into breast milk during breastfeeding. Although there are no current established methods for accurately detecting silicone levels in breast milk, a study measuring silicon (one component in silicone) levels did not indicate higher levels in breast milk from women with silicone gel-filled implants when compared to women without implants. In addition, concerns have been raised regarding potential damaging effects on children born to mothers with implants. Two studies in humans have found that the risk of birth defects overall is not increased in children born after breast implant surgery. Although low birth weight was reported in a third study, other factors (for example, lower pre-pregnancy weight) may explain this finding. A recent epidemiological review found that children of women with breast implants are not at increased risk for birth defects. Instructions for Use Criteria for patient selection are the responsibility of the surgeon. Information contained within this document should be taken into consideration during the selection process. The surgeon should discuss with the patient prior to surgery possible risks, precautions, warnings, consequences, complications, and adverse reactions associated with the surgical procedure and implantation of the breast implant. Surgical Procedures Correct surgical procedures and techniques are the responsibility of the medical profession. Each surgeon must evaluate the suitability of the procedure based upon current accepted techniques, individual judgment and experience. Proper size and shape of implants must be determined for the individual patient by the surgeon. Recognition of the appropriate indications and contra-indications and the selection of the proper surgical procedures and techniques determined to be best for the patient are the responsibility of the surgeon. Some of the surgical and implant sizing variables that have been identified as UNIGEL -12- UNIGEL -13-

9 being important include: Sterile product is supplied in a sealed, double primary package. Sterility is not guaranteed if the package has been damaged or opened. Patient frame size(e.g. the implant diameter is not too large for the breast and chest wall dimensions.) Tissue coverage of the implant(especially when there is limited breast tissue coverage and/or limited subcutaneous fat) Surgical plane of placement(the submuscular plane may be preferable in patients with minimal, thin, and/or poor quality overlying tissue in order to minimize palpation, visibility, and/or erosion of any wrinkles or folds in the implant, if they should occur.) Size of implant pocket(create a pocket of adequate size and symmetry so that the implant may be placed flat and the surface of the implant adequately smoothed to assure a minimum of wrinkling at the surface.) Each surgeon must, of course, evaluate the appropriateness of the procedure based on his or her own training and experience. Various factors must be considered by the surgeon indetermining the proper size and shape of the implant used with a particular patient. UNIGEL is available in many standard sizes. It is advisable to have more than one size breast implant in the operating room at the time of the surgery to allow the surgeon flexibility in determining the appropriate size implant to be used. Prior to use, the implant should be carefully examined for structural integrity and cleanliness. A back-up implant should be available in the event of implant damage/rupture or contamination. A damaged or contaminated implant should not be used. SEWOON MEDICAL intends that this breast implant product should be used only by physicians having received appropriate training in plastic surgery techniques. Supplied Sterile Implants are supplied in sterile form by EO gas sterilization or dry heat sterilization, processed by validated strictly controlled Sterilization cycles. Sterility is verified in accordance with standards. Sterility of the implants is maintained only if the package is intact and undamaged. Single Use Implants are intended for SINGLE USE ONLY. DO NOT REUSE EXPLANTED PRODUCTS. DO NOT RESTERILIZE ANY PRODUCT. Explanted products should not be reused because re-cleaning and re-sterilization procedures may not adequately remove biological residues, such as blood, tissue and other matter, which could retain resistant pathogens. Packaging The sterile breast implant is enclosed in a double sealed blister package to provide enhanced assurance of sterility. Product is considered sterile as long as the package integrity has not been compromised. Two labels, patient record label and patient device card label to record pertinent data, e.g. catalog number, product volume, lot number, etc., and patient device card are supplied. These labels should be filled out and made a part of the patient s permanent records. And, Patient record label and patient device card are tear-off label. These are to be attached to the patient s record and patient device card. Patient Record Each product is supplied with two patient labels (a patient recode label and a patient device card label) showing the catalogue, lot number, serial number, style and size, enclosed with a patient device card. A patient record label should be attached directly to the patient s chart. Patient Device Card Enclosed with each product is a patient device card. To complete the patient device card, place one device identification sticker for each implant on the back of the card. Stickers are located on the internal product packaging attached to the patient device card label. If a sticker is unavailable, the lot number, catalog number and description of the device may be copied by hand from the patient device label. Patients should be provided with these cards for personal reference. Device Tracking Form For the purpose of Post Market Surveillance requested by the observance of legal and regulatory standards, enclosed Device Tracking Form should be filled in and sent to the distributor or the manufacturer by or fax. Patient registration in this Device Tracking Form is strongly required to have benefit of UNIGEL Life Time Premium Warranty Program. To Open Packaged Sterile Product 1) Attach patient record label to patient chart 2) Firmly hold the outer package blister so that the outer cover is pointing away from the person opening the package under clean, aseptic conditions. 3) Grasp outer cover film and peel open completely to end seal. 4) Drop sterile inner package into sterile field. 5) Open inner package in the same manner as the outer package. 6) Lift the sterile implant from the inner blister well. 7) The implant should be visually examined for any evidence of particulate contamination, damage or leakage. 8) When the integrity of the implant is confirmed, submerge it in sterile saline prior to implantation to prevent contact with airborne a surgical field particulate contaminants. Note that foreign body reactions can be caused by drape and sponge lint, glove powder, talc, fingerprints, and other surface contaminants. Care should be taken to prevent contamination of product. Handling of the sterile implant should be minimized. UNIGEL -14- UNIGEL -15-

10 Storage 1) Keep away from sunlight and dampness. 2) Store at 15 C~30 C Return of Goods Policy Prior to the return of any product: 1) Authorization must be requested in writing. 2) Decontamination certificate must be supplied with a product returned which has been in contact with body fluid. 3) If it is necessary to puncture the shell of any sealed shell product to assist with safe decontamination sterilization procedures, the area of mechanical interference should be marked with indelible marker on the surface of the product and reference made on the decontamination certificate. Limited Warranty SEWOON MEDICAL disclaims and excludes any implied warranty or merchantability or fitness for a particular purpose in connection with the products subject to this transaction. No other warranties, written or oral, are authorized whether express or implied by operation of law or otherwise. SEWOON MEDICAL warrants that reasonable care in selection of materials and methods of manufacture were used in fabrication of this product. No responsibility is assumed for any incidental or consequential loss damage or expense directly or indirectly arising from the use of this device. The foregoing limited warranty is given in lieu of and in substitution for any and all other warranties of any kind of description whatsoever, specifically including the implied warranty of the character or condition of the products. SEWOON MEDICAL further disclaims any express warranties concerning the products other than the foregoing limited warranty. Manufacturer Product Ordering To place an order, please send your order form by fax or contact directly the sales department at SEWOON MEDICAL CO.,LTD. 60 Dorim-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si, Chungcheongnam-do, Korea Phone: Fax: Dorim-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si, Chungcheongnam-do, Korea Phone: Fax: European Representative 1 The Forrest Units, Hennock Road East, Marsh Barton, Exeter, EX2 8RU, UK Phone: Fax: SWML-UG-IFU01(Rev.3) UNIGEL -16-

11 60 Dorim-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si, Chungcheongnam-do, Korea Phone: Fax: