Oct 2005 ISBN: Breast Implants. Information for women considering breast implants

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1 Oct 2005 ISBN: Breast Implants Information for women considering breast implants

2 Forward Preface It gives me great pleasure to support this publication as part of the Health Promotion services of my Department. We wish to provide women with as much information as possible to allow them to make an informed choice in relation to their health. I hope the publication will highlight the questions to be asked and the problems to be considered by women considering implant surgery. MARY HARNEY TD Tánaiste & Minister for Health & Children This publication was produced on behalf of the Department of Health & Children by a sub-committee of the Advisory Committee for Medical Devices at the Irish Medicines Board. The need to provide information for women considering breast implant surgery was identified by the European Parliament and the European Commission. The Advisory Committee for Medical Devices was delighted to be able to assist the Department in the production of this important health information document. I would like to acknowledge the advice and assistance of all those associated with this publication, in particular: Margaret O Donnell, Consultant Plastic Surgeon, and Mary Murray, Clinical Nurse Specialist, St Vincent s Hospital. Dr Barbara Tucker Medical Devices Assessor, and Ann O Connor, Medical Devices Director, Irish Medicines Board. WILFRID J HIGGINS Chairman Advisory Committee for Medical Devices

3 Contents 1. Introduction 1. Introduction 2. Reasons for having a breast implant 3. Are breast implants the only option? 4. Types of implants 5. The role of your general practitioner 6. The operation 7. Short-term effects of surgery 8. Long-term risks of breast implantation 9. Other issues to be aware of 10 Choosing your surgeon 11 Things to talk to your surgeon about 12 Consent to surgery 13 Glossary of terms 14 References The information in this booklet is being provided for women considering the option of breast implant surgery. The aim of the booklet is to assist women in making an informed choice about breast implants before opting for surgery. The information has been compiled by a subcommittee of the Advisory Committee for Medical Devices at the Irish Medicines Board and has included consultation with health professionals and representatives of interested organisations. The content of this publication is based on the recommendations of a number of publications on Silicone Breast Implants 6, 7, 8, and the European Commission Communication on Community and National Measures in Relation to Breast Implants 5. In February 2003 breast implants were reclassified as required by Commission Directive 2003/12/EC 4. This Directive was transposed into Irish law by Statutory Instrument No.358 of

4 2. Reasons for having a breast implant 3. Are breast implants the only option? Generally speaking there are two reasons for having a breast implant: 1. For breast augmentation (enlargement) or 2. For breast reconstruction following mastectomy Less frequently, a woman may be born without one or both breasts and she may consider breast implant surgery. It is important to have realistic expectations of breast implant surgery and understand that the final result will be influenced by many factors such as, the shape of your existing breasts, your age, your skin texture and its healing properties. Breast implants may not last a lifetime and may need to be replaced in the future. This will involve further surgery. All operations carry risks and non-surgical options may be more appropriate for some women, for example, breast enhancing bras or an external prosthesis. Women with droopy breasts may benefit from implant surgery, but in some cases the appearance of the breasts may be worse after implantation and it may be more appropriate to consider an operation called a mastopexy (breast lift) to tighten the skin of the breast. A mastopexy is occasionally done at the same time as implant surgery, if the aim is to both enlarge and lift the breasts. It is important that you have all the information you need to make an informed decision about which option is the best for you. Your surgeon and breast care nurse will be able to answer any questions you may have.

5 4. Types of implants 5. Role of your General Practitioner Synthetic breast implants are surrounded by a firm silicone shell. The most commonly used implants are filled with either silicone gel or saline. You should discuss with your surgeon the advantages and disadvantages of the particular implant which is being recommended for you. Implant manufacturers provide booklets with their products, which may also contain valuable information on the implant which is being considered for you. Take time to read the information before you consent to surgery. You should discuss your decision to have breast implant surgery with your general practitioner. (S)he knows your general health status and may offer you a valuable second opinion on whether or not breast implant surgery is the best option for you. If you decide to have breast implant surgery, (s)he will be able to refer you to an appropriate surgeon. (S)he will also be available after you have had surgery to play a role in your follow up. If a woman has undergone a mastectomy for breast cancer her surgeon may choose to implant a tissue expander rather than a breast implant. A tissue expander is an inflatable balloon-like device made from elastic silicone rubber. It is inserted unfilled and over time sterile saline fluid is added. As the expander is filled with fluid the overlying tissue stretches and this creates space for a breast implant. Some tissue expanders may be left in place long-term but others are replaced at a second operation by a breast implant.

6 6. The operation 7. Short-term effects of surgery Your surgeon will discuss the details of your operation with you. The time your operation will take depends on whether you are having augmentation or reconstructive surgery. Reconstructive usually takes longer. If you have had a mastectomy, muscle and skin from your back or abdomen may be used in addition to, or instead of, an implant. In most cases, breast implant surgery is performed under general anaesthesia. Your length of stay in hospital will depend on the type of surgery you have, your general health and whether or not you have any short-term effects after your surgery. Women who have had surgery for breast cancer may consider breast reconstruction. This can be done at the time of mastectomy (immediate) or as a separate operation some time later (delayed). Your surgeon will advise you whether immediate or delayed surgery is more appropriate. Chemotherapy and radiotherapy may influence the choice of reconstruction. Following your operation you can expect to have some pain, swelling and bruising of your breast and may have changes in the sensation in your breast or nipples. The lack of sensation may be temporary or permanent. You should talk to your surgeon or general practitioner promptly if: your breasts are excessively swollen; your breast is hot; there is an offensive discharge from the wound, or you have a temperature. You may have an infection which requires treatment. Excessive swelling may also be due to fluid collection (haematoma or seroma) which may require further surgery. Surgery always causes scarring. Your surgeon will be able to describe the location, size and appearance of the scars you can expect. Scars fade over time, but are permanent. In some patients scars may remain prominent. In rare cases tissue in the breast can break down (tissue necrosis) and your breast implant may need to be removed.

7 8. Long-term risks of breast implantation It is important that you are aware of the potential long-term risks associated with breast implant surgery. The following are some recognised risks: Capsular Contracture The body considers an implant to be a foreign material and will form a layer of scar tissue (capsule) around the implant. If the capsule shrinks (contracts) the implant may become deformed. This is the commonest complication of breast implants. As a consequence you may experience pain and hardening of the breast. You may need additional surgery to correct the contracture or to remove the implant and, if appropriate, to replace it with another implant. Deflation and rupture Breast implants cannot be guaranteed to last forever. Some implants will deflate or rupture in the first few months after implantation, some after several years and others remain intact 10 or more years after surgery. When silicone gel filled implants rupture, women may notice decreased breast size, swelling, nodules of silicone (siliconomas) in the breast or other body tissue, asymmetry of the breasts, pain, or changes in sensation of the breast. Sometimes the woman may be unaware of the rupture i.e. silent rupture and it may be appropriate to perform a MRI scan to assess the status of the implant. The filler of the implant may stay in the implant after rupture or it may leak out into the surrounding tissue. In the case of rupture of silicone filled implants, the silicone is more likely to stay inside the capsule. Occasionally however, the silicone may spread outside the capsule and lodge in the breast or further away, for example, in the muscles under the breast, the armpit, arm or abdomen. This may cause tenderness in the breast or may form nodules (siliconomas). Your surgeon may decide to remove your breast implant. If you are having a mammogram you should tell the radiographer of the presence of implants to avoid the risk of rupture. Silicone leakage and the Silicone Controversy Most people are exposed to silicone in everyday life. It is found in products such as processed food and hair spray. A number of women have reported symptoms of illness following their breast implant surgery. These symptoms include muscle spasm and pain, rashes, swollen tender joints and hair loss. A Group was set up by the Department of Health in the UK to examine whether or not there was evidence to support the association between these symptoms and breast implants. The Report of this Group 6, which was published in 1998 did not find any scientific association between silicone gel implants and long-term illness in which the whole body is affected (systemic illness), nor with specific connective tissue disease. These findings were supported by later studies in the United States 7 and the European Parliament. 8 Your surgeon will be able to give you up to date information on current research on this area.

8 9. Other issues to be aware of Dissatisfaction with cosmetic results It is not possible to accurately predict the appearance of the breasts after breast implant surgery. Even knowing the size of the breast implant used will not accurately predict the bra size that you will wear after surgery. Every patient is different and bra size will vary from patient to patient. It can take several months for breast implants to settle into place and for breasts to look more natural. Pre-operative differences in sizes of breasts may be magnified by implants. Breast asymmetry or inequality noted before breast implant surgery may become more obvious afterwards. Creasing, rippling, folding and kinking of the breast tissue, which you may or may not find acceptable, can be apparent after breast implant surgery. The capsule which forms around your breast implant may be the cause of these visible changes. Breast implants feel firm but similar to the natural breast. However, as they are firm they may not fall to the side when you lie down and you may not have a natural looking cleavage. Scarring which is the response of the body to any form of surgery is usually acceptable. However, in some women the scars may be red and thickened or highly coloured and can take years to improve in appearance. Nipple sensation may be changed by your surgery and nipples may become tender or numb. While this is usually temporary, in a rare situation may be permanent. Breast cancer Breast cancer is no more frequent in women with breast implants. Silicone has not been shown to increase the incidence of breast cancer. Breast implants may interfere with mammography for breast cancer detection. Women who have implants should tell the radiographer so that more views can be taken as necessary. Calcium deposits around the implants may make it difficult for the radiologist to assess the mammogram. It is important that every woman, with or without implants, is breast aware. This means knowing what is normal for you so that if any unusual changes occurs you will recognise them. Breastfeeding You may have concerns about your ability to breastfeed. Breast implants are unlikely to interfere with your ability to breastfeed. Women who have had a mastectomy and breast implantation will not be able to feed through that side due to the loss of glandular breast tissue as a result of the mastectomy. The shape of the woman s breasts may change after breastfeeding both in the woman who has breast implants and the woman who has not. There is no study to show conclusively that silicone passes from implants into breast milk and there is no evidence to suggest that children of women with breast implants have an increased chance of illnesses. Silicone is present in the environment and we are continuously exposed to it in our everyday lives.

9 10. Choosing Your Surgeon 11. Things to talk to your surgeon about You should discuss the choice of surgeon with your GP. Ask them to refer you to a surgeon who: is registered with the Medical Council is on the Register of Medical Specialists for Plastic Surgery: or is a consultant in a hospital with a recognised specialty in plastic surgery. You should find out what follow-up medical support is available, in case there are any complications. There are some surgeons carrying out cosmetic surgery procedures who do not have a practice in Ireland. What do you want? What types of implants are available? What size implant do you want? What will happen? What will happen during the surgery? How long will it take? What are the side effects? How long will I take to recover? When can I go back to work? Will I be able to drive or lift things? What it will look like? What will they look like straight after the surgery? What will they look like after a few weeks? Where will the scars be and what will they look like? Where will the implants go? How long will the scars take to heal? What can go wrong and what will happen if it does? What might go wrong during or after the operation? What are the possible long-term problems with breast implant surgery? Who can I see if there are any problems once I go home? Will it be you?

10 Other questions What follow up care is available in the coming years? What role will you play in any follow up care? Is there a breast care nurse? What about my GP? What does current research say about breast implants? Will I be able to breastfeed? What about breast cancer and screening? Important points to remember Implants are not guaranteed to last a lifetime. You may need more surgery to replace or remove the implants during your lifetime. Follow up after implant surgery is required given the known postoperative complications of surgery and long term consequences of breast implants. Your surgeon should give you the details of your implant so that you have a permanent record. Changes to your breast following implantation may be irreversible. Routine screening mammography may be more difficult to perform. Any surgery or medical treatment after the operation in the future may be expensive.

11 12. Consent to Surgery Sample informed consent form Breast implant surgery is available to women over the age of 18 years. It may be appropriate to consider breast implant surgery at a younger age if there is a congenital or developmental abnormality of the breast. Once you have read the information in this booklet, and the information from the manufacturer of your implant and discussed the issues with your consultant you will be asked to sign a consent form for the surgery. It is important to take time to think carefully about all the information you have received. It is important that you take as much time as you need, at least 30 days to consider all the options available to you before you consent to surgery. I...D.O.B... of Have read and understand the information contained in this booklet Have read and understand the information contained in the manufacturer's booklet Have discussed the risks and benefits of breast implant surgery with my surgeon I hereby consent to breast implantation surgery Signed by...(patient) or Signed by...(parent/guardian) Date...

12 13. Glossary of terms Auto-immune diseases A group of diseases in which the body's immune system attacks the body's own tissue e.g. scleroderma, rheumatoid arthritis or systemic lupus erythematosus. Breast augmentation Surgery to increase the size of the breast. Capsule The body responds to the presence of a foreign body by forming scar tissue round it. The scar tissue around the breast implant is called a capsule. Capsular contracture The capsule around the breast implant tightens. Congenital deformity A deformity which is present from birth. External prosthesis An artificial substitute for the breast, which is worn externally. Haematoma A collection of blood within body tissues. Magnetic Resonance Imaging (MRI) A medical diagnostic technique which can be used to create images of the breast and surrounding tissues. It uses radio waves within a magnetic field to create the images. It can be used to detect abnormalities including implant rupture etc. Mammogram An X-ray to detect breast abnormalities. Mastectomy A surgical operation to remove the breast. Mastopex A surgical operation to tighten the skin around the breast which is performed to lift the breast. Nodules (Siliconomas) Small lumps which sometimes form in the breast and other body tissues around leaked silicone from silicone implants. These are benign nodules. Saline Salt water used to fill saline breast implants and tissue expanders. Saline is absorbed easily by the body if the implant ruptures or leaks. Saline is found naturally within the body. Seroma Fluid accumulation in the body tissue. Silicon Silicone is a chemical element occuring in nature. It is a constituent of sand and glass. Silicone Silicone is a plastic or polymer made partly from silicon. Silicone can come in solid, liquid or gel forms. Tissue expander An inflatable balloon-like device made from elastic silicone rubber. It is inserted unfilled and over time sterile saline fluid is added. It is used to stretch the skin of the breast to make room for a breast implant. Tissue necrosis A breakdown of body tissue.

13 14. References 1. Statutory Instrument (S.I) No.252 of 1994, European Communities (Medical Devices) Regulations Council Directive 93/42/EEC of 14 June 1993 concerning Medical Devices OJ L 169,12/07/1993 available at, 3. Statutory Instrument (S.I) No.358 of European Communities (Medical Devices) (Reclassification of Breast Implants) (Amendment) Regulations Informative Websites 1. Medicines and Healthcare Products Regulatory Agency Food and Drug Administration (FDA), USA Irish Medicines Board Commission Directive 2003/12/EC of 3rd February 2003 on Reclassification of Breast Implants in the framework of Directive 93/42/EEC concerning Medical Devices. OJ L 028,04/02/ Communication from the European Commission on Community and National Measures in relation to Breast Implants November 2001 available at 6. Review of the Independent Review Group: Silicone Gel Breast Implants, available at 7. Safety of Silicone Breast Implants. Institute of Medicine National Academy Press, Washington, D.C.2000 (IOM Report) at 8. Health risks posed by silicone implants in general, with special attention to breast implants. Moreno, Prof. J.M., Scientific Technology Options Assessment Group of the European Parliament.

14 This booklet has been prepared to provide guidance for persons considering the use of breast implants. These implants may be associated with potential long-term risks and complications. The Department of Health & Children recommends that you consider the information provided for a period of 30 days before making a final decision. Produced by the Department of Health & Children in conjunction with the Medical Devices Advisory Committee of the Irish Medicines Board.

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