GETTING THE BEST RESULTS FROM BREAST AUGMENTATION
20 June 2018
When it comes to breast augmentation, patients are typically looking to increase their breast size, but there are a few other key factors to keep in mind when choosing the right breast implants that will both achieve the desired results and highlight your natural figure.
When considering breast implants, it is important to distinguish between cup size and implant size. Bra sizes are not uniform and can vary from brand to brand and by style, whereas implant sizes are uniform and are measured in cubic centimeters of volume. Discussing the difference with your surgeon can help find the right match for you.
It’s similarly vital to know what you are looking for as a result of the surgery. Some patients seek subtle improvements while others hope for dramatic changes. Visually, patients may be looking to increase cleavage, lift sagging breasts, or alter breast position.
Another aspect to consider is your lifestyle. If you work out, play a lot of sports, or have a physically demanding job, this could affect the size of breast implants you choose. Of course, women who lead an active life can still enjoy implants, just in some cases a smaller increase in volume may be a better choice.
Perhaps most importantly for those having breast augmentation is to have good rapport with your surgeon. Be sure to clearly communicate your goals and discuss them with your doctor. He or she will be able to help you choose the right size for implants as well as possibly suggesting a breast lift to go with the augmentation. In the office you will also have the opportunity to look at before and after photos to find pictures of women with similar body types and see how their augmentation improved their appearance.
WHAT TO ASK YOUR SURGEON BEFORE BREAST AUGMENTATION
15 June 2018
Before making a final decision on considering breast augmentation it’s essential to be able to ask your surgeon the right questions during your consultation.
The first thing to do is ask your surgeon if breast augmentation is right for you. This will entail letting him or her know your ultimate goals which will provide the information needed to let you know if breast augmentation will help you achieve those goals. Next, ask for advice on choosing the right implant size. Generally, those getting breast implants a part of their cosmetic surgery want to choose a size that complements their figure and still maintains a natural look. You should also talk to your doctor about the difference between your options for the type of implants. The final look and feel of your augmentation could be affected by this decision and your doctor will be able to help you choose according to your individual plan. When consulting with your surgeon about breast augmentation, get to know the surgical techniques that are available. Submuscular and subglandular implants offer different advantages for different body types and lifestyles. Bringing this up during your consultation will help you get the best results.
Finally, it is important to ask what the recovery will be like. Your surgeon should be able to give you a good idea of how long it will take to return to work, your normal exercise routine, and more. With this knowledge you will be able to prepare your home to make your recovery more comfortable and stock up on supplies you will need. Many women can return to work in a week or two and resume exercise in four to six weeks, but it depends on other personal factors.
As with any other procedure, the more knowledge and understanding of the breast augmentation process you have, the better chances of success you will have. Having an experienced, trustworthy, and friendly surgeon is important in getting the results you want.
CUTTING EDGE TECHNOLOGY ALLOWS WOMEN TO VISUALISE THEIR NEW BODIES BEFORE BREAST AUGMENTATION
10 June 2018
The 4D Crisalix scanning device projects images of your potential figure to help you choose your implant size. After undressing and getting the distances between your nipples measured, the distances between your sternum and nipples measured and the distance from each nipple to your ribcage recorded, you simply need to stand as still as you can while you are scanned from every angle possible – which is where the 4D visualisation begins.
The iPad I use has the Crisalix camera scan device attached to it, it scans in real time, in 4D and the imaging software recreates your body on the iPad screen – every contour precisely rendered in front of you! A tap of a button and your body appears on screen in the consultation room. In addition to scanning every curve, roll, wrinkle and mole on your top half, it’s also scanned your skin tone, which is replicated exactly on the screen.
One second and a tap of my screen later and you have the breasts you’ve always wished you had. Fuller, natural, it is likely your silhouette is completely different and you’ve been able to see what you’d look like with implants without having to go under the knife – even the moles you have are recreated with the precision scanner.
The amazing thing about the Crisalix technology is that I can make sure – as a surgeon – that I am on the same aesthetic page as the patient that I’ll be operating on. I’ve had women in consultation tell me adamantly they want a 400cc implant but no two bodies are the same and until this imaging software there wasn’t an accurate way to show patients what their implants would look like in their bodies.
My Crisalix technology puts the power in the hands of the patient which can only be a good thing.
SMALLER IMPLANTS CAN OFFER A MORE FIT AND ATHLETIC LOOK
01 June 2018
Many of my patients come to me thinking bigger is always better, even when their body type could benefit from smaller implants.
With the breast augmentation gaining momentum a few years back, women were opting for large breast implants. However, the scenario has changed and women are looking for more natural results with breasts that look less obviously enhanced. This is leading to the trend of 3D imaging for breast augmentation. 3D imaging provides a higher chance of offering results as per the plan. This is also helping women to choose the implant size that results in the natural looking breast augmentation. Lifestyle is the most important factor in a decision to undergo a cosmetic surgery. Hence, women are seeking breast implants to balance the figure than to dominate their appearance.
To balance an active lifestyle, many women prefer smaller implants that can offer a more fit and athletic look. Advancement in breast augmentation technology is resulting in improved design, fill volumes and construction, accelerating the development of new devices that leads to less wrinkling and rippling.
Fillers in Dubai: Tips to Achieve Successful Outcomes
Fillers in Dubai
INTRODUCTION
Dermal fillers have revolutionized the field of cosmetic dermatology. With the aging of baby boomers, dermal fillers have become a sought-after rejuvenation procedure as they offer a youthful, three-dimensional look with minimal downtime. Dermal fillers are gaining popularity because of the increased attention by the media and the availability of a wide array of filler materials available at prices more affordable than before. The use of fillers for soft tissue augmentation with the synergistic use of botulinum toxin and a variety of complementary procedures has become the mantra for rejuvenation.
Presently, the fillers available in India vary in source, longevity, site of deposition, and cost. The focus of this article is to analyse the fillers available in the market and to provide practical tips that would enable the dermatologist derive optimal results for the patient.
CLASSIFICATION OF FILLERS
Fillers can be classified either on the basis of longevity in tissues, or based on their source.
Based on longevity
Fillers are classified as temporary, semipermanent, or permanent. Temporary fillers stay in the tissue for less than a year, semipermanent fillers for up to 1–2 years, whereas permanent fillers are substances that remain in the tissue more than two years. However, there is some confusion in the classification of semipermanent and permanent status of some fillers, with some sources classifying any filler that lasts more than one year as permanent.
Based on the origin
Fillers may be classified depending on their source as:
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Human
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Animal
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Synthetic
Knowing the source of the filler is important as it helps the dermatologist to take decisions about the need for preskin testing and to know the patient’s preference. Many patients may not wish to use animal products for religious or personal reasons.
Temporary fillers
Temporary fillers are also referred to as nonpermanent fillers. Their stay in the tissue is for less than 12 months and hence, they have the advantage of spontaneously disappearing if the patient is not satisfied with the results. Similarly, an adverse event with such fillers is also a temporary one, as seen in the majority of the cases. However, rare permanent side effects have been reported even with temporary fillers.
Some of the common temporary fillers available in India are described here:
Bovine collagen-based products
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Zyderm 1
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Zyderm 2
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Zyplast
Human tissue-derived collagen
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Cosmoderm
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Cosmoplast
Synthetic fillers: Hyaluronic acid-based fillers
A wide range of hyaluronic acid products is available with varying hyaluronic acid concentrations and cross-linking structure and hence, also in their indications
Fillers in Dubai Table 1
Temporary fillers, their indications, and sites of placement
Semipermanent fillers
Semipermanent fillers undergo slow degradation with time over a period of 1–2 years. Side effects with semipermanent fillers are more common and longer lasting than temporary fillers.
Fillers in Dubai Table 2
Semipermanent fillers, their indications, and sites of placement
Permanent fillers
Permanent fillers are fillers that remain for longer than two years in the tissyue. Side effects with permanent fillers tend to be more permanent, and complication is the main issue with any permanent filler.
Fillers in Dubai Table 3
Permanent fillers, their indications, and sites of placement
Other materials, which are less commonly used, include Artefill and Silicone.
INDICATIONS OF DERMAL FILLERS
Fillers are mainly used in the rejuvenation of facial areas. However, dermal fillers may also be used in nonfacial areas and for cutaneous defects.
Facial areas
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Wrinkles and folds
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Lip Augmentation
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Depressed scars – postsurgical, traumatic, postacne, chickenpox, and other diseases
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Enhancement of facial contour
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Periocular melanoses and sunken eyes
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Dermatological diseases – angular cheilitis, dermal atrophy, AIDS lipodystrophy
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Earring ptosis, atrophic earlobes
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Nasal depressions
Nonfacial areas
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Neck
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Décolleté } Rejuvenation
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Hands
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Corns and calluses – to reduce contact points, pain, and risk of ulcer formation
CONTRAINDICATIONS
Complications of fillers are generally rare; they include:
Absolute
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Hypersensitivity to products
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Unrealistic expectations
Relative
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Keloidal tendency
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Patients with autoimmune disease
PATIENT EDUCATION AND ASSESSMENT
Patients should be counseled about the nature of the filler, what to expect, longevity, any possible side effects, and the cost. An assessment of both the physical and psychological states of the patient is necessary for a successful outcome. Written informed consent ensures compliance with regulatory and legal requirements as well as the management of the patient’s expectations. Pre- and post- photographs are important to critically analyse the results of the treatment and also, to prepare for medico-legal situations.
PROCEDURE OF FILLER INJECTION
The aesthetic benefit for the patient with temporary fillers can be attributed to 90% technique and 10% substance, whereas it is usually 99% technique with permanent fillers.[3]
Preparation and anaesthesia
The area of injection and also the surrounding skin should be cleaned properly with antiseptics. Anaesthesia is important for technical benefit and the patient’s comfort. Anaesthesia can be ensured by:
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Application of ice
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Topical EMLA cream application
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Regional nerve blocks – infraorbital, mental, maxillary, submucosal – as applicable, depending on the area
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Distraction Techniques such as massage, application of vibration
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Talking in a soothing and comforting manner – Talkesthesia
Injection technique
The choice of the injection technique depends on the indication, its location, the filler substance, size of the needle, and the experience of the injector. The techniques include:
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Linear threading technique
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Serial puncture
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Fanning
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Cross-hatching
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Depot
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Fern
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Cone
The first four techniques are used commonly, whereas the last three are only used in special situations. It is important to place the filler in the right place and the bevel orientation is not a significant issue at any site.
Postinjection management
Patients should be asked to avoid extreme cold or heat for 48 hours. Massaging of the treated area and strenuous physical activity should be avoided for six hours. Patients are asked to sleep with their heads elevated for one night; skin care routine may be followed after 24 hours.
Measures to achieve successful outcomes
A comprehensive treatment plan should be devised to suit the needs of each patient. Choosing the right filler for the right indication is vital. Where essential, combinations of fillers with botulinum toxin should be used to optimize the results. In such cases, it is advisable to inject the botulinum toxin first, wait for a week to see the improvement, and then, inject the filler to achieve best results.
FACIAL ANATOMIC AREAS: SPECIAL CONSIDERATIONS
Glabella area
Always choose patients with a positive glabella test. Inject small boluses relatively superficially, using only moderate pressure while injecting. Always watch for erythema and stop injecting when you see blanching as this will reduce the incidence of ischaemic necrosis which is common in this area. Techniques used in this area are usually a combination of linear threading and serial puncture techniques.
Nasolabial fold
This is the ideal indication to start with for a novice injector. Stretch and compress the skin to visualize the fold. Inject into a site medial to the fold to avoid further cheek ptosis. Overcorrection is common here and this leads to change in animation, lumpiness, and bumpiness. Remember that nasolabial folds always display a degree of natural asymmetry which should be discussed with the patient prior to injection. Usually a linear threading or a fern technique is chosen to treat this area.
Lips
The lips are the focal centre of the lower face. It is always important to consider antiviral prophylaxis in a patient with a history of herpes simplex episodes.
The height of the lips and the proportion of the upper to lower lip should be considered. The lower lip should protrude slightly beyond the upper lip. The upper lip should be 2/3 of the volume of the lower lip. Usually lip augmentation is done with a larger particle-sized filler in contrast to lip line augmentation which is done with a smaller gel particle-sized filler. Overcorrection of the upper lip can lead to a “duck bill” appearance. As lips swell immediately following the injection of the filler, steroid prophylaxis needs to be considered.[7]
A linear threading technique is done for volume augmentation and a microdroplet technique is used very rarely when one has to inject near the submucosal area.
Periocular area
The best candidates are younger patients with thicker skin and minimal to moderate volume loss. A depot injection at the level of the periosteum essentially traps the gel implant creating a long-lasting effect. Edema and ecchymosis are quite common in this area. Too superficial placement or thin skin in this area can lead to visibly pale nodules or Tyndall effect. Injection of filler into the periocular area is a difficult procedure and only a person with good training and experience should attempt it. One should also be aware of serious side effects such as blindness (see under complications).
COMPLICATIONS OF FILLERS
Temporary fillers have fewer complications and transient adverse effects when compared to semipermanent and permanent fillers. Adverse effects could be injection-related or filler material-related and may appear either immediately or later.
Early complications
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Hypersensitivity reactions
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Haematomas and ecchymoses
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Infections – reactivation of herpes simplex
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Nonhypersensitivity-related swelling
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Acneiform eruptions
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Erythema – transient or permanent
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Skin necrosis
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Embolism (blindness)
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Tyndall effect
Late complications
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Implant migration
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Telangiectasia
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Granulomas
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Lipoatrophy
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Hypertrophic scarring
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Sterile abscess
The treatment of complications should be aggressive and initiated as soon as possible after occurrence. Effective treatment of complications and assuring patients in the interim are the keys to successful practice.
NOVEL THERAPEUTIC AGENTS AS DERMAL FILLERS
Stem cells
Adipose tissue is easily obtained through liposuction and it provides a good source of stem cells which serve as a useful agent for soft tissue regeneration or repair. It has been found that fatty tissue has the highest percentage of adult stem cells of any tissue in the body with about 5000 adipose-derived stem cells per gram of fat vs 100–1000 stem cells per milliliter of bone marrow.
Autologous vein transplantation
Autologous vein transplantation can be performed with the unwanted veins of the patient. The procedure involves extracting varicose or other unwanted leg or hand veins of the patient, soaking the vein in hypertonic saline to destroy endothelial cells, and then, implanting portions of the remaining material (containing collagen, elastin, and muscle) into the dermal defect. The endothelium is destroyed to prevent newer angiogenesis in the implanted area. So far the results have been long-lasting with no complications. Although results are encouraging, this procedure is laborious at present, and is restricted to patients with unwanted veins.
CONCLUSION
With a variety of fillers flooding the market and with the aging of baby boomers aspiring to retain their youthfulness, careful selection of the patient, the dermal filler, and the technique can maximise patient satisfaction and lead to a successful outcome
Breast Augmentation Dubai With Sientra Silicone Gel Breast Implants
Breast Augmentation Dubai | 1 March 2018
Breast Augmentation Dubai – A surgical procedure to increase breast size and to treat such conditions as sagging or drooping of the breast (ptosis) or breasts of different size, shape, or placement (asymmetry). The first time a breast implant is placed to increase breast size or treat such conditions as ptosis or asymmetry, it is referred to as “primary augmentation.” Any time there is another surgery to replace the implant, it is referred to as “revision-augmentation.” Any surgically implanted artificial device intended to replace missing breast tissue or to enhance a breast. A lump in the breast.
Abdomen Anaplastic Large Cell Lymphoma (ALCL) Areola Asymmetry Atrophy Autoimmune Disease Biocompatible Biopsy Body Dysmorphic Disorder (BDD) Body Esteem Scale The part of the body between the upper chest (breasts) and the pelvis (hips); often called the stomach. ALCL is not breast cancer; it is a rare type of non-Hodgkin’s lymphoma (cancer of the immune system). The pigmented or darker colored area of skin surrounding the nipple. Uneven appearance between a woman’s left and right breasts in terms of their size, shape, or breast level. Thinning or diminishing of tissue or muscle. An autoimmune disease is a disease in which the body’s immune system attacks its own cells or tissues by mistake, causing damage and dysfunction. Autoimmune diseases can affect connective tissue in the body (the tissue that binds together body tissues and organs). Autoimmune diseases can affect many parts of the body, like nerves, muscles, glands and the digestive system. The ability to exist along with living tissues or systems without causing harm. The removal and examination of tissue, cells, or fluid from a living body. A psychological condition characterized by excessive worry about an imagined or minor physical flaw to the point that it can interfere
with normal daily activities. A series of questions asking about a person’s feelings about his or her body.
Breast Augmentation Dubai
reconstruct a breast after tissue was taken out because of cancer or injury. Breast reconstruction also includes the surgical correction of a breast that has failed to develop properly due to a severe abnormality or congenital defect. The first time a breast implant is placed to replace breast tissue is referred to as “primary reconstruction.” Any time there is another surgery to replace the implant, it is referred to as “revision-reconstruction.” The process of a soft tissue hardening when the mineral calcium builds up in a certain place. Tightening of the scar tissue (also called a capsule) that normally forms around the breast implant during the healing process after surgery. In some women, the scar tissue (capsule) squeezes the implant. When this occurs, it is called capsular contracture. This results in firmness or hardening of the breast. Capsular contracture is classified by a scale named Baker Grade.
Breast Implant
Breast Mass
Breast Reconstruction A surgical procedure to replace breast tissue or
Calcification/ Calcium Deposits Capsular Contracture
etc. and/or the immune system. Connective tissue diseases (“CTDs”) that involve the immune system include autoimmune diseases such as rheumatoid arthritis, lupus, and scleroderma. A use that is improper and should not be followed. Failure to follow contraindications identified in the labeling could cause serious harm. The major clinical study that supports the approval of a medical product (such as breast implants). For Sientra’s breast implants, the CORE study includes augmentation, reconstruction, and revision (revision-augmentation and revision-reconstruction) patients. Information on the safety and effectiveness of the implants are collected every year for 10 years after study participants get their implants.
Breast Augmentation Dubai – Displacement Extrusion Fibrocystic Breast Disease Fibromyalgia Fibrous Tissues
The production and secretion of milk by the breast glands. Complications that occur in the breast or chest area. Lymph nodes are glands that play an important part in the body’s defense against infection. They produce lymph, which travels throughout the body in the lymph system, and filters impurities from the body. Common areas where the lymph nodes can be felt with the fingers include: groin, armpit, neck, under the jaw and chin, behind the ears, and on the back of the head. Enlarged lymph node(s). When the implant is placed incorrectly during the initial surgery or when the implant has moved/shifted from its original position. Shifting can be caused by many factors, such as gravity, trauma, poor initial placement, and capsular contracture. Pertaining to the breast. A type of x-ray examination of the breasts used for detection of cancer. Plastic surgery of the breast. Surgical procedure to raise and reshape sagging breasts.
Death of cells or tissues. Palpability is when the implant can be felt through the skin. Visibility is when the implant can be seen through the skin. Major muscle of the chest. The areola is the pigmented or darker colored area of skin surrounding the nipple. Periareolar refers to the area just around the areola. Around the belly button. Surgery intended to enhance or improve the appearance of the body. A metallic element used to help make both silicone elastomer (the rubbery material of the breast implant shell) and silicone gel. After surgery. Information that warns the reader of a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. Any artificial device used to replace or represent a body part. Sagging or drooping of the breast. Bleeding at the surgical site that causes discoloration and varies in degree and length of time. This is expected following breast implant surgery or other breast procedures. Removal of the implant, with or without replacement using another implant. Any additional surgery performed to the breast or chest area after the first breast implantation. The chance or likelihood that an undesirable effect will occur.
A hole or tear in the shell of the implant that allows silicone gel filler material to leak from the shell. Saltwater (A solution made of water and a small amount of salt). A surgical procedure to improve the appearance of a scar. Formation of tissue at an incision site; all wounds heal by the formation of a scar. Similar to a bruise, a seroma occurs when the watery portion of the blood collects around a surgical incision or around a breast implant. The Short Form 36 Health Scale; a questionnaire intended to measure physical, mental, and social health. The clinical Study that supports the approval
of a medical product (such as breast implants). For Sientra’s breast implants, the Study includes augmentation, reconstruction, and revision
(revision-augmentation and revision-reconstruction) patients. Information on the safety and effectiveness of the implants are collected every year for 10 years after Study participants get their implants. A breast implant rupture without symptoms or a visible change. Silent rupture cannot be felt by the woman or detected by a doctor through physical examination. Silent rupture can only be discovered through appropriate imaging techniques such
as MRI. Silicone is a man-made material that can be
found in several forms such as oil, gel, or rubber
(elastomer). The exact make-up of silicone will be different depending on its use.
Sientra, the company that sells these Silicone Gel Breast Implants, has designed this educational brochure to help you understand breast augmentation and to help you talk with your doctor(s) about breast augmentation. Sientra sponsored a large clinical study of these breast implants (also referred to in this brochure as the “Study”) that gathered data about these breast implants. The Study collected data from the primary augmentation and revision-augmentation cohorts of the CORE study, as well as pooled data from Sientra’s CORE and Continued Access studies for the primary reconstruction and revision-reconstruction cohorts. There are 1,788 patients participating in the Study. A total of 1,115 patients had primary augmentation and 362 patients had revision-augmentation. Of the 229 patients who had primary reconstruction, 156 patients were from the CORE study and 73 were from the Continued Access study. Of the 82 patients who had revision-reconstruction with Sientra Silicone Gel Breast Implants, 50 were from the CORE study and 32 were from the Continued Access study. Results from the Study are presented in Section 8 of this brochure. After you receive this information, give yourself time to read and think about the information. Because breast implants will require monitoring and care for the rest of your life, you should wait 1-2 weeks after reviewing and considering this information before deciding whether to have the surgery.
If you are having revision-augmentation surgery, your surgeon may advise you to have the surgery sooner. If you decide to have the surgery, you will be asked to sign a statement before the surgery. The statement says you have read and understood the information in this brochure and that you have been informed of the benefits and risks of breast implants. This statement is called the “Acknowledgement
of Informed Decision,” and there is a copy of it at the end
of this brochure. Make sure all of your questions have
been answered and you understand the information in
this brochure, before you sign the “Acknowledgement of Informed Decision.”
About Breast Augmentation With Breast Implants
The information in this section provides some general information about breast augmentation with breast implants
As shown in Figure 1, your breast consists of milk ducts, glands, blood vessels, and nerves that are surrounded by fatty tissue. Glandular tissue is firm and gives the breast its shape. The fatty tissue gives the breast its soft feel. The chest muscle (the pectoralis major muscle) is located underneath all this breast tissue but does not have much effect on the shape or feel of the breast.
What Is A Silicone Gel Breast Implant?
A silicone gel breast implant is a sac (implant shell) made of silicone elastomer (rubber), which is filled with clear silicone gel. Sientra uses implant grade silicone elastomer and implant grade high-strength silicone gel to manufacture its Implants. Sientra’s Implants are designed to resemble the human breast in shape, weight and feel. Sientra’s Implants are available in a variety of shapes and sizes, with either a smooth or textured surface. You and your surgeon can choose the Sientra round or shaped implant option that best suits your individual needs. Round implants provide volume in the upper breast area (called upper pole area). Shaped implants are intended to match the anatomy of your chest wall. Depending on your needs, shaped implants can also provide more or less volume in the upper pole area. Refer to Section 6.3 – CHOOSING THE RIGHT IMPLANT FOR YOU, for more information on the different silicone gel breast Implants available from Sientra.
Breast Augmentation Dubai? Breast implants are used to make the breasts larger or to restore or replace breast tissue. They are surgically implanted beneath your breast tissue, either on top of the chest muscle (subglandular placement) or underneath part or all of the chest muscle (submuscular placement).
stays within the scar tissue (capsule) around the implant. Sometimes, the gel does not stay there and may move to other areas around the body (gel migration). There have been rare reports of gel moving to nearby tissues such as the chest wall, armpit, or upper abdominal wall, and to more distant locations down the arm or into the groin. One group of researchers found silicone in the livers of women with ruptured silicone gel breast implants.1 Sometimes silicone travels into the lymph nodes. When silicone gel moves into the lymph nodes, they may become enlarged. When silicone gel moves into lymph nodes or other parts of the body, small hardened lumps of silicone (called silicone granulomas) may be felt. These lumps are NOT cancer, but it can be hard to tell them from cancerous lumps just by feeling them. If you feel any lumps in your breasts, around your breasts, in your armpits or anywhere in your body, your doctor should examine them. Your doctor may have to remove a small amount of tissue from the lump(s)
(called taking a biopsy) to find out if the lump is cancer. Before having a biopsy, be sure to tell your doctor that you have breast implants. Studies have been done to find out what, if any, effects migrated silicone gel has on the body.1-5 In most cases, no serious problems were reported. Several studies report that some women with migrated silicone gel experienced breast hardness, numbness and/or tingling in their extremities, and some seemed more sensitive to sunlight.1,4,6 In a few cases, migrated gel has caused nerve damage, hard silicone nodules (granulomas) in the body, and/or breakdown of the body tissues around the gel.5 Most doctors and researchers agree that there is NO evidence that ruptured implants or migrated gel causes
any disease that affects the whole body (systemic disease) like Connective Tissue Disease (CTD) or cancer. However, one group of researchers2,3 reported that women who had migrated silicone gel had a higher risk of getting a CTD. This is discussed more fully in Section 4.2.
or without being replaced) at some point during the course of your life. You and your doctor may decide to remove an implant or implants because of a complication or to improve the cosmetic result. Based on the experiences of augmentation patients in the Study, the 3-year risk of implant removal (including removal with replacement for a size exchange) is 6% for primary augmentation patients and 11% for revision-augmentation patients. This means that 6 out of 100 primary augmentation patients and 11 out of 100 revision-augmentation patients who receive Silicone Gel Breast Implants may need to have one or both implant removed within 3 years after receiving their implants. Implant removal information from the Study is discussed more fully in Section 8.6.