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Encyclopedia > Breast implant

A breast implant is a prosthesis used to enlarge the size of a woman's breasts (known as breast augmentation, breast enlargement, mammoplasty enlargement, augmentation mammoplasty or the common slang term boob job) for cosmetic reasons; to reconstruct the breast (e.g. after a mastectomy; or to correct genetic deformities), or as an aspect of male-to-female sex reassignment surgery. According to the American Society of Plastic Surgeons, breast augmentation is the most commonly performed cosmetic surgical procedure in the United States. In 2006, 329,000 breast augmentation procedures were performed in the U.S. A United States Army soldier plays table football with two prosthetic arms Jon Comer, professional skateboarder with a prosthetic leg. ... For other uses, see Breast (disambiguation). ... Plastic surgery is a general term for operative manual and instrumental treatment which is performed for functional or aesthetic reasons. ... Breast reconstruction is the rebuilding of a breast, usually in women. ... In medicine, mastectomy is the medical term for the surgical removal of one or both breasts, partially or completely. ... This article does not cite any references or sources. ... The American Society of Plastic Surgeons (ASPS) is the largest plastic surgery specialty organization in the world. ... Year 2006 (MMVI) was a common year starting on Sunday of the Gregorian calendar. ...


There are two primary types of breast implants: saline-filled and silicone-gel-filled implants. Saline implants have a silicone elastomer shell filled with sterile saline liquid. Silicone gel implants have a silicone shell filled with a viscous silicone gel. There have been several alternative types of breast implants developed, such as polypropylene string or soy oil, but these are uncommon and not recommended. Not to be confused with the element silicon. ... In medicine, saline is a solution of sodium chloride (a substance also commonly known as table salt) in sterile water, used frequently for intravenous infusion, rinsing contact lenses, and nasal irrigation (or the yogic practice called jala neti). ... Not to be confused with the element silicon. ... Please wikify (format) this article or section as suggested in the Guide to layout and the Manual of Style. ...


Implants have been used since 1895 to augment the size or shape of women's breasts. The earliest known implant was attempted by Vincenz Czerny, using a woman's own adipose tissue (from a lipoma, a benign growth, on her back).[1] Gersuny tried paraffin injections in 1889, with disastrous results. Subsequently, in the early to mid-1900s, a number of other substances were tried, including ivory, glass balls, ground rubber, ox cartilage, Terylene wool, gutta-percha, Dicora, polyethylene chips, polyvinyl alcohol-formaldehyde polymer sponge (Ivalon), Ivalon in a polyethylene sac, polyether foam sponge (Etheron), polyethylene tape (Polystan) or strips wound into a ball, polyester (polyurethane foam sponge) Silastic rubber, and teflon-silicone prostheses.[2] In recent history, various creams and medicaments have been used in attempts to increase bust size, and Berson in 1945 and Maliniac in 1950 performed a flap-based augmentation by rotating the patient's chest wall tissue into the breast to add volume. Various synthetics were used throughout the 1950s and 1960s, including silicone injections, which an estimated 50,000 women received.[3] Development of silicone granulomas and hardening of the breasts were in some cases so severe that women needed to have mastectomies for treatment. Women sometimes seek medical treatment for complications up to 30 years after receiving this type of injection. Year 1895 (MDCCCXCV) was a common year starting on Tuesday (link will display full calendar) of the Gregorian calendar (or a common year starting on Sunday of the 12-day-slower Julian calendar). ... For other uses, see Breast (disambiguation). ... Vincenz Czerny (Trutnov, 19 November 1842 - Heidelberg, 3 October 1916) was a German surgeon whose main contributions were in the fields of oncological and gynecological surgery. ... Adipose tissue is one of the main types of connective tissue. ... A lipoma is a common, benign tumor composed of fatty tissue. ... For other uses, see Paraffin (disambiguation). ... This article or section does not cite its references or sources. ... Species About 100-120 species, including: Palaquium amboinense Palaquium barnesii Palaquium bataanense Palaquium beccarianum Palaquium borneense Palaquium burckii Palaquium clarkeanum Palaquium cochleariifolium Palaquium dasyphyllum Palaquium ellipticum Palaquium formosanum Palaquium galactoxylum Palaquium gutta Palaquium herveyi Palaquium hexandrum Palaquium hispidum Palaquium hornei Palaquium impressinervium Palaquium kinabaluense Palaquium lanceolatum Palaquium leiocarpum Palaquium lobbianum... This article does not cite any references or sources. ... Chemical structure of polyvinyl alcohol Polyvinyl alcohol (PVOH, PVA, or PVAL) is a water-soluble synthetic polymer. ... H&E section of non-caseasting granuloma seen in the colon of a patient with Crohns disease In medicine (anatomical pathology), a granuloma is a group of epithelioid macrophages surrounded by a lymphocyte cuff. ... In medicine, mastectomy is the medical term for the surgical removal of one or both breasts, partially or completely. ...


Breast implants are used for:

  • primary augmentation (to increase breast size for cosmetic reasons)
  • revision-augmentation (revision surgery to correct or improve the result of an original breast augmentation surgery)
  • primary reconstruction (to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality)
  • revision-reconstruction (revision surgery to correct or improve the result of an original breast reconstruction surgery)

Contents

Patient characteristics

Patients seeking breast augmentation have been reported as being usually younger, healthier, from higher socio-economic status, and more often married with children than the population at large.[4] Many of these patients have reported greater distress about their appearance in a variety of situations, and have endured teasing about their appearance. Studies have identified a pattern (shared by many cosmetic surgery procedures) that suggest women who undergo breast implantation are slightly more likely to have undergone psychotherapy, have low levels of self-esteem, and have higher prevalences of depression, suicide attempts, and mental illness (including body dysmorphia[5]) as compared to the general population.[6] Post-operative surveys on mental health and quality of life issues have reported improvement on a number of dimensions including: physical health, physical appearance, social life, self confidence, self esteem, and sexual function.[7][8][9][10] Longer term follow-up suggests these improvements may be transitory, with the exception of body esteem related to sexual attractiveness.[11] Most patients report being satisfied long-term with their implants even when they have required re-operation for complications or aesthetic reasons.[12][7] For other uses, see Depression. ... For other uses, see Suicide (disambiguation). ... Body dysmorphic disorder (BDD) is a mental disorder, which involves a disturbed body image. ...

Procedure

The surgical procedure for breast augmentation takes approximately one to two hours. Variations in the procedure include the incision type, implant material, and implant pocket placement.

Image File history File links Metadata No higher resolution available. ...

Incision types

Breast implants for sluts and hoes who have no fucking life

  • Inframammary - an incision is placed below the breast in the infra-mammary fold (IMF). This incision is the most common approach and affords maximum access for precise dissection and placement of an implant. It is often the preferred technique for silicone gel implants due to the longer incisions required. This method can leave slightly more visible scars in smaller breasts which don't drape over the IMF. In addition, the scar may heal thicker.
  • Periareolar - an incision is placed along the areolar border. This incision provides an optimal approach when adjustments to the IMF position or mastopexy (breast lift) procedures are planned. The incision is generally placed around the inferior half, or the medial half of the areola's circumference. Silicone gel implants can be difficult to place via this incision due to the length of incision required (~ 5cm) for access. As the scars from this method occur on the edge of the areola, they are often less visible than scars from inframammary incisions in women with lighter areolar pigment. There is a higher incidence of capsular contracture with this technique.
  • Transaxillary - an incision is placed in the armpit and the dissection tunnels medially. This approach allows implants to be placed with no visible scars on the breast and is more likely to consistently achieve symmetry of the inferior implant position. Revisions of transaxillary-placed implants may require inframammary or periareolar incisions (but not always). Transaxillary procedures can be performed with or without an endoscope.
  • Transumbilical (TUBA)[13] - a less common technique where an incision is placed in the navel and dissection tunnels superiorly. This approach enables implants to be placed with no visible scars on the breast, but makes appropriate dissection and implant placement more difficult.[citation needed] Transumbilical procedures may be performed bluntly or with an endoscope (tiny lighted camera) to assist dissection. This technique is not appropriate for placing silicone gel implants due to potential damage of the implant shell during blunt insertion.
  • Transabdominoplasty (TABA)[14] - procedure similar to TUBA, where the implants are tunneled up from the abdomen into bluntly dissected pockets while a patient is simultaneously undergoing an abdominoplasty procedure.

Cross section of the breast of an adult, female human. ... Mastopexy or breast lift surgery refers to a group of elective surgical operations designed to lessen the degree of breast ptosis (the droop of the breasts). ... The most popular and common questions that regard the risks in a breast augmentation surgery are concerning the recovery period and the procedure itself. ... Endoscopy means looking inside and refers to looking inside the human body for medical reasons. ...

Types of implants

Saline implants

Silicone gel-filled breast implants
Silicone gel-filled breast implants

Saline-filled breast implants were first manufactured in France in 1964, introduced by Arion[15] with the goal of being surgically placed via smaller incisions. Current saline devices are manufactured with thicker, room temperature vulcanized (RTV) shells. These shells are made of silicone elastomer and the implants are filled with salt water after the implant is placed in the body. Since the implants are empty when they are surgically inserted, the scar is smaller than is necessary for silicone gel breast implants (which are filled with silicone before the surgery is performed). A single manufacturer (Poly Implant Prosthesis, France) produced a model of pre-filled saline implants which has been reported to have high failure rates in vivo.[16] Wikipedia does not have an article with this exact name. ... Wikipedia does not have an article with this exact name. ...


Saline-filled implants were most common implant used in the United States during the 1990's due to restrictions that existed on silicone implants, but were rarely used in other countries. Good to excellent results may be obtained, but as compared to silicone gel implants, saline implants are more likely to cause cosmetic problems such as rippling, wrinkling, and be noticeable to the eye or the touch. Particularly for women with very little breast tissue, or for post-mastectomy breast reconstruction, it's felt that silicone gel implants are the superior device. In patients with more breast tissue in whom submuscular implant placement is used, saline implants can look very similar to silicone gel.


Silicone gel implants

Thomas Cronin and Frank Gerow, two Houston, Texas, plastic surgeons, developed the first silicone breast prosthesis with the Dow Corning Corporation in 1961. The first woman was implanted in 1962. Silicone implants are generally described in terms of five generations which segregate common characteristics of manufacturing techniques. Houston redirects here. ... For other uses, see Texas (disambiguation). ... For the album by The Huntingtons, see Plastic Surgery (album). ... Dow Corning is a multinational corporation headquartered in Midland, Michigan, USA. Dow Corning specializes in silicone-based technology and innovation, offering more than 7,000 products and services. ... Year 1961 (MCMLXI) was a common year starting on Sunday (link will display full calendar) of the Gregorian calendar. ... Year 1962 (MCMLXII) was a common year starting on Monday (the link is to a full 1962 calendar) of the Gregorian calendar. ...

  • First generation

The Cronin-Gerow implants were made of a silicone rubber envelope (or sac), filled with a thick, viscous silicone gel with a Dacron patch on the posterior shell.[17] They were firm and had an anatomic "teardrop" shape.

  • Second generation

In response to surgeons' requests for softer and more lifelike implants, breast implants were redesigned in the 1970s with thinner, less cohesive gel and thinner shells. These implants had a greater tendency to rupture and leak, or "bleed" silicone through the implant shell, and complications such as capsular contracture were quite common. It was predominantly implants of this generation that were involved in the class action-lawsuits against Dow-Corning and other manufacturers in the early 1990s. The most popular and common questions that regard the risks in a breast augmentation surgery are concerning the recovery period and the procedure itself. ...


Another development in the 1970s was a polyurethane foam coating on the implant shell which was effective in diminishing capsular contracture by causing an inflammatory reaction that discouraged formation of fibrous tissue around the capsule. These implants were later briefly discontinued due to concern of potential carcinogenic breakdown products from the polyurethane.[18] A review of the risk for cancer from TDA by the FDA later concluded that the risk was so small so as not to justify recommending explantation of the devices from individual patients. Polyurethane implants are still used in Europe and South America, but no manufacturer has sought FDA approval for sale in the United States.[19] Second-generation implants also included various "double lumen" designs. These implants were essentially a silicone implant inside a saline implant. The double lumen was an attempt to provide the cosmetic benefits of gel in the inside lumen, while the outside lumen contained saline and its volume could be adjusted after placement. The failure rate of these implants is higher than for single lumen implants due to their more complex design. The contemporary versions of these devices ("Becker Implants") are used primarily for breast reconstruction. The 1970s decade refers to the years from 1970 to 1979, also called The Seventies. ...

  • Third & Fourth generation

Third & fourth generation implants, from the mid 1980s, represented sequential advances in manufacturing principles with elastomer-coated shells to decrease gel bleed, and are filled with thicker, more cohesive gel. These implants are sold under restricted conditions in the U.S. and Canada, and are widely used in other countries. The increased cohesion of the gel filler reduces potential leakage of the gel compared to earlier devices. A variety of both round and tapered anatomic shapes are available. Anatomic shaped implants are uniformly textured to reduce rotation, while round devices are available in smooth or textured surfaces.

  • Fifth generation

Evaluation of "gummy bear" or solid, high-cohesive, form-stable implants is in preliminary stages in the United States but these implants have been widely used since the mid 1990s in other countries. The semi-solid gel in these type of implants largely eliminates the possibility of silicone migration. Studies of these devices have shown significant potential improvements in safety and efficacy over the older implants with low rates of capsular contracture and rupture. [20][21][22] For the show based on the candy, see Disneys Adventures of the Gummi Bears. ...


Implant pocket placement

Subglandular breast implant diagram

The placement of implants is described in relation to the pectoralis major muscle. Image File history File links BreastImplant(inamed35). ... Image File history File links BreastImplant(inamed35). ... The Pectoralis major is a thick, fan-shaped muscle, situated at the upper front (anterior) of the chest wall. ...

  • Subglandular- implant between the breast tissue and the pectoralis muscle. This position closely resembles the plane of normal breast tissue and is felt by many to achieve the most aesthetic results. The subglandular position in patients with thin soft-tissue coverage is most likely to show ripples or wrinkles of the underlying implant. Capsular contracture rates are also slightly higher with this approach, and placement of implants in this pocket might be inappropriate in women who are at risk for capsule formation (smokers, multiple breast surgeries).
  • Subfascial [23] - the implant is placed in the subglandular position, but underneath the fascia of the pectoralis muscle. The benefits of this technique are debated,[24] but proponents believe the (sometimes thick) fascial sheet of tissue may help with coverage and sustaining positioning of the implant. Implants that undergo capsular contraction are unlikely to displace upward or toward the underarm.
  • Subpectoral ("dual plane")[25] - the implant is placed underneath the pectoralis major muscle after releasing the inferior muscular attachments. As a result, the implant is partially beneath the pectoralis in the upper pole, while the lower half of the implant is in the subglandular plane. This is the most common technique in North America and achieves maximal upper implant coverage while allowing expansion of the lower pole. Animation or movement of the implants in the subpectoral plane can be excessive to some patients.
  • Submuscular - the implant is placed below the pectoralis without release of the inferior origin of the muscle. Total muscular coverage may be achieved by releasing the lateral chest wall muscles (serratus and/or pectoralis minor) and sewn to the pectoralis major. This technique is most commonly used for maximal coverage of implants used in breast reconstruction.

Recovery

Depending on the level of activity required, patients are generally able to return to work or school in approximately one week's time. Women who have their implants placed underneath the muscle (submuscular placement) will generally have a longer recovery time and experience slightly more pain due to the muscle being cut during surgery. During initial recovery it is important not to use the arms or strain the body in any way, and to avoid cigarettes. Scars from a breast augmentation surgery will last six weeks or longer and usually begin to fade several months after surgery.


Claims of Systemic illness and disease

Since the early 1990s, a number of independent systemic comprehensive reviews have examined studies concerning links between silicone gel breast implants and systemic diseases. The consensus of these reviews is that there is no clear evidence of a causal link between the implantation of silicone breast implants and systemic disease.[26][27][28][29]


Thousands of women claim that they have become ill from their implants. Complaints include neurological and rheumatological problems. Some studies have suggested that subjective and objective symptoms of women with implants may improve when their implants are removed.[30] Neurology is a branch of medicine dealing with disorders of the nervous system. ... Rheumatology, a subspecialty of internal medicine, is devoted to the diagnosis and therapy of rheumatic diseases. ...


As studies have followed women with implants for a longer period of time, more data has become available on systemic diseases as well as autoimmune symptoms. Several large studies from the national health registry in Denmark found implant recipients no more likely to be diagnosed with an increased incidence of classic auto-immune symptoms as compared to women of the same age in the general population,[31] and that musculoskeletal symptoms were generally lower among women with implants compared with women with other cosmetic surgery and women in the general population.[32] Recent longitudinal follow-up of these patients has confirmed previously reported findings.[33]


Several studies have established that women who elect to undergo breast augmentation or other plastic surgery tend to be healthier and more affluent than the general population, prior to surgery and afterwards. For example, two large studies of plastic surgery patients found a decreased standardized mortality ratio in both breast implant and other plastic surgery patients, but an increased risk of respiratory cancer deaths in breast implant recipients compared to other forms of plastic surgery. Smoking was statistically controlled in one study and not in the other, but the authors speculated that there could potentially be differences in smoking that might contribute to the higher lung cancer deaths among women with implants.[34][35] Another large study with long-term follow-up of nearly 25,000 Canadian women with implants reported, "Findings suggest that breast implants do not directly increase mortality in women."[36] The standardized mortality ratio in epidemiology is the ratio of observed deaths to expected deaths in a population. ...


In 2001 a study suggested an increase in fibromyalgia among women with extracapsular silicone gel leakage, compared to women whose implants were not broken or leaking outside the capsule.[37] This association has not repeated in a number of related studies,[38] and the US-FDA concluded "the weight of the epidemiological evidence published in the literature does not support an association between fibromyalgia and breast implants."[39] Fibromyalgia (FM or FMS) is a chronic syndrome (constellation of signs and symptoms) characterized by diffuse or specific muscle, joint, or bone pain, fatigue, and a wide range of other symptoms. ...


While there is a general international consensus that silicone implants have not been shown to cause systemic illness, excluding the possibility that a small group of patients may become ill through (as yet) unknown mechanisms may prove difficult. As the US-FDA notes "researchers must study a large group of women without breast implants who are of similar age, health, and social status and who are followed for a long time (such as 10-20 years) before a relationship between breast implants and these diseases can conclusively be made."[39]


Complications

Local complications that can occur with breast implants include post-operative bleeding (hematoma), fluid collections (seroma), surgical site infection, breast pain, alterations in nipple sensation, interference with breast feeding, visible wrinkling, asymmetric appearance, wound dehiscence (with potential implant exposure), thinning of the breast tissue, and synmastia (disruption of the natural plane between breasts). Hematoma on thigh, 6 days after a fall down stairs, 150ml of blood drained a few days later A hematoma, or haematoma, is a collection of blood, generally the result of hemorrhage, or, more specifically, internal bleeding. ... A seroma is a pocket of clear serous fluid that sometimes develops in the body after surgery. ...


Rupture

Ruptured silicone implant with removed capsule

Breast implants can potentially remain intact decades in the body, but all such devices will fail at some point. When saline breast implants break, they often deflate quickly and can be easily removed. Prospective studies of saline-filled breast implants showed rupture/deflation rates of 3-5% at 3 years and 7-10% at 5 years for augmentation patients.[39] Image File history File linksMetadata Download high resolution version (1600x1200, 1019 KB) Licensing I, the creator of this work, hereby release it into the public domain. ... Image File history File linksMetadata Download high resolution version (1600x1200, 1019 KB) Licensing I, the creator of this work, hereby release it into the public domain. ...


Among the suspected mechanisms for rupture are damage during implantation or other procedures, degradation of the implant shell, blunt or penetrating chest trauma, and in rare instances from the pressure of traditional mammograms.[40]


The age and design of the implant are the most important factors in rupture, but estimating ruptures rates of contemporary devices has been difficult, as most previous reports[41] mixed heterogeneous groups of devices in non-randomized populations. The only available literature with longer term available MRI data on single lumen 3rd/4th generation silicone implants comes from Europe and has reported silent rupture rates of an implant at between 8% to 15% at or around a decade (or 15-30% of patients).[42][43][44] The first series of MRI evaluation of the highly-cohesive (5th generation) gel implants suggests improved durability, with a rupture rate reported at 1% or less at a median age of six years.[45]


It's been suggested that clinical exams alone are inadequate to evaluate suspected rupture after a study reported that only 30% of ruptures in asymptomatic patients are accurately detected by experienced plastic surgeons, compared to 86% detected by MRIs [46] The US-FDA has recommended that MRIs be considered to screen for silent rupture starting at three years after implantation and then every two years thereafter.[47] Other countries have not endorsed routine MRI screening, and have taken the position that MRI should be reserved only for cases involving suspected clinical rupture or to confirm mammographic or ultrasound studies suggesting rupture.[29]


When silicone implants break they rarely deflate, and the silicone from the implant can leak out into the space around the implant. An intracapsular rupture can progress to outside of the capsule (extracapsular rupture), and both conditions are generally agreed to indicate the need for removal of the implant. Extracapsular silicone has the potential to migrate, but most clinical complications have appeared to be limited to the breast and axillae [48] in the form of granulomas (inflammatory nodules) and axillary lymphadenopathy [49] (enlarged lymph glands in the armpit area).[50] The specific risk and treatment of extracapsular silicone gel is still controversial. In medicine (anatomical pathology), a granuloma is a group of epithelioid macrophages surrounded by a lymphocyte cuff. ... The armpit (or axilla) is the area on the human body directly under the area where the arm connects to the shoulder. ... Lymphadenopathy is a term meaning disease of the lymph nodes. ...


Capsular contracture

See main article, Capsular contracture
High grade (Baker IV) capsular contracture in the right breast around a subglandular gel implant.
High grade (Baker IV) capsular contracture in the right breast around a subglandular gel implant.

Capsules of tightly-woven collagen fibers form as an immune response around a foreign body (eg. breast implants, pacemakers, orthopedic joint prosthetics), tending to wall it off. Capsular contracture occurs when the capsule tightens and squeezes the implant. This contracture is a complication that can be very painful and distort the appearance of the implanted breast. The exact cause of contracture is not known. However, some factors include bacterial contamination, silicone rupture or leakage, and hematoma. Capsular contracture may happen again after this additional surgery. The most popular and common questions that regard the risks in a breast augmentation surgery are concerning the recovery period and the procedure itself. ... Image File history File links No higher resolution available. ... Image File history File links No higher resolution available. ... A request has been made on Wikipedia for this article to be deleted in accordance with the deletion policy. ... The most popular and common questions that regard the risks in a breast augmentation surgery are concerning the recovery period and the procedure itself. ... Hematoma on thigh, 6 days after a fall down stairs, 150ml of blood drained a few days later A hematoma, or haematoma, is a collection of blood, generally the result of hemorrhage, or, more specifically, internal bleeding. ...


Methods which have reduced capsular contracture include submuscular implant placement, using textured[51][52] or polyurethane-coated implants,[53] limiting handling of the implants and skin contact prior to insertion[54] and irrigation with triple-antibiotic solutions.[55]


Correction of capsular contracture may require surgical removal or release of the capsule, or removal and possible replacement of the implant itself. Closed capsulotomy (disrupting the capsule via external manipulation), a once common maneuver for treating hard capsules, has been discouraged as it can cause implant rupture. Nonsurgical methods of treating capsules include massage, external ultrasound,[56] treatment with leukotriene pathway inhibitors (Accolate, Singulair),[57][58]and pulsed electromagnetic field therapy.[59] Leukotrienes are autocrine and paracrine eicosanoid lipid mediators derived from arachidonic acid by 5-lipoxygenase. ...


Scarring

All surgical procedures on the breast leave scars. Scar quality is determined by factors including a patient's ethnicity, tissue quality, wound tension, suture material, tissue trauma from surgery, smoking, and an individuals propensity for favorable wound healing. While most breast augmentation incisions heal well, a rate of 6-7% of unfavorable scarring was reported for primary augmentation patients in US-FDA clinical trials.[47][60]


Chronic pain and changes in nipple and breast sensitivity

Feeling in the nipple and breast can change after implant surgery. Changes include intense sensitivity, chronic breast pain, and no feeling in the nipple or breast for months or years after surgery.


In their booklets for patients, Allergan and Mentor report that within the first three years, between 2-8% of augmentation patients report moderate to severe chronic breast pain, an additional 1-2% report moderate to severe breast sensitivity changes, and 3-10% report moderate to severe nipple complications such as loss of sensation.[47][60][61] These are similar for silicone gel or saline breast implants, but the longer-term data on saline implants indicates that chronic breast pain is reported by 17% of women within five years.


This altered sensitivity can be temporary or permanent and may affect sexual response or the ability to nurse a baby.


Implant extrusion and tissue necrosis

Compromise of blood supply as a result of surgical procedures may lead to skin loss or breast tissue necrosis (death). Unstable or weakened tissue covering may result in subsequent extrusion of the breast implant through the skin. Implant extrusion and tissue necrosis are rare in breast augmentation patients, but may occur in up to 2-3% of reconstruction patients using implants.[47] Surgery needed to correct this can result in unacceptable scarring or breast tissue loss.[60] Procedures which combine simultaneous breast augmentation with mastopexy (breast lift) techniques carry higher rates of implant loss or wound breakdown than either procedure alone. Mastopexy or breast lift surgery refers to a group of elective surgical operations designed to lessen the degree of breast ptosis (the droop of the breasts). ...


Platinum

Platinum is a catalyst used in the making of silicone implant polymer shells and other silicone devices used in medicine. The literature indicates that small amounts of platinum leaches (leaks) from these implants and is present in the surrounding tissue. The FDA reviewed the available studies from the medical literature on platinum and breast implants in 2002 and concluded there was little evidence suggesting toxicity from platinum in implant patients.[62] General Name, Symbol, Number platinum, Pt, 78 Chemical series transition metals Group, Period, Block 10, 6, d Appearance grayish white Standard atomic weight 195. ... It has been suggested that this article or section be merged into Catalysis. ...


In 2006, researchers published a controversial study that claimed to identify the previously undocumented presence of toxic platinum oxidative states in vivo.[63] A letter from the editors of the publishing journal, Analytical Chemistry, subsequently expressed concern over the research's experimental design and urged the journal's readers to "use caution in evaluating the conclusions drawn in the paper."[64] The FDA reviewed this study and the existing literature, concluding that the body of existing research did not support their findings, and that the platinum in new implants is likely not ionized and therefore would not represent a significant risk to women.[65]


Cancer screening

The presence of radio-opaque breast implants may interfere with the sensitivity of screening mammography. Specialized radiographic techniques where the implant is manually displaced (Eklund views) may improve this somewhat, but approximately 1/3 of the breast is still not adequately visualized with a resultant increase in false-negative mammograms.[66] A number of studies looking at breast cancers in women with implants have found no significant difference in stage of disease at time of diagnosis, and prognosis appears to be similar in both groups with augmented patients not a higher risk for subsequent cancer recurrence or death.[67][68] Conversely, the use of implants for reconstruction after mastectomy for breast cancer also appears not to have a negative effect on cancer-related mortality.[69]


An observation that patients with implants are more often diagnosed with palpable tumors (but not larger ones) suggest that tumors of equal size may be more easily palpated in augmented patients, and this may compensate somewhat for the potential impairment of mammography.[53] This palpability is due to thinning of the breast by compression, innately smaller breasts a priori, and that the implant serves as a base against which the mass may be differentiated.[70]


The presence of a breast implant does not influence the ability for breast conservation (lumpectomy) surgery for women who subsequently develop breast cancer, and does not interfere with delivery of external beam radiation (XRT) treatments that may be required.[71] Fibrosis of breast tissue after XRT is common and an increase in capsular contracture rates would be expected.


Repair or revision surgery

Regardless of the type of implant, it is likely that women with implants will need to have one or more additional surgeries (re-operations) over the course of their lives. Most common indications for re-operations have included major or minor complications, capsular contracture treatment, and replacement of ruptured/deflated implants.[40] Re-operation rates are predictably more frequent in breast reconstruction cases due to the dramatic changes in the soft-tissue envelope and anatomical breast borders after mastetcomy, particularly when patients have received adjuvant XRT.[40] Breast cancer patients also frequently undergo staged procedures for reconstruction of the nipple-areola complex (NAC) and symmetry procedures on the opposite breast.


It appears that re-operation rates in cosmetic cases can be improved by more carefully matching individual patients' soft-tissue characteristics to the type and size of implants used. Using appropriate device selection and proper technique, re-operation rates at up to seven years followup have been reported as low as 3%,[72][73] as compared with the 20 percent re-operation rate at 3 years in the most recent Food and Drug Administration study.


Controversy

Since the early 1990's, nearly a dozen comprehensive systemic reviews have been commissioned by various governments' health ministries to examine the alleged links between silicone gel breast implants and systemic diseases. A clear consensus has emerged from these independent scientific reviews that there is no clear evidence of a causal link between the implantation of silicones and connective tissue disease. The conclusions of these reviews are summarized:

Year Country Systemic Review Group Conclusions
1991-1993 United Kingdom Independent Expert Advisory Group (IEAG) The IEAG concluded that there was no evidence of an increased risk of connective tissue disease in patients who had undergone silicone gel breast implantation and that there was no scientific case for changing practice or policy in the UK in respect of breast implantation
1996 USA US Institute of Medicine (IOM) [74] Not "sufficient evidence for an association of silicone gel- or aline-filled breast implants with defined connective tissue disease".
1996 France Agence Nationale pour le Developpement de l'Evaluation Medicale (ANDEM)[1] "Nous n’avons pas observé de connectivite ni d’autre pathologie auto-immune susceptible d’être directement ou indirectement induite par la présence d’un implant mammaire en particulier en gel de silicone..." (We did not observe connective tissue diseases to be directly or indirectly associated with (in particular) silicone gel breast implants)
1997 Australia Australia’s Therapeutic Devices Evaluation Committee review "current high quality literature suggest that there is no association between breast implants and connective tissue disease-like syndromes (atypical connective tissue diseases)"[2]
1998 Germany Germany’s Federal Institute for Medicine and Medical Products concluded that "silicone breast implants neither cause auto-immune diseases nor rheumatic diseases and have no disadvantageous effects on pregnancy, breast feeding capability or the health of children who are breast fed. There is no scientific evidence for the existence of silicone allergy, silicone poisoning, atypical silicone diseases or a new silicone disease" [75]
2000 USA Review request of the United States Federal Judiciary[76] "no evidence of an association between...silicone-gel-filled breast implants specifically, and any of the individual CTDs, all definite CTDs combined, or other autoimmune or rheumatic conditions."
2000 European Union European Committee on Quality Assurance & Medical Devices in Plastic Surgery (EQUAM) "Additional medical studies have not demonstrated any association between silicone-gel filled breast implants and traditional auto-immune or connective tissue diseases, cancer, nor any other malignant disease....EQUAM continues to believe that there is no scientific evidenxce that silicone allergy, silicone intoxication, atypical disease or a 'new silicone disease' exists."[3]
2001 Great Britain UK Independent Review Group (UK-IRG) "there is no evidence of an association with an abnormal immune response or typical or atypical connective tissue diseases or syndromes"[4]
2001 USA Review for court appointed National Science Panel [77] The panel evaluated both established and undifferentiated connective tissue diseases and concluded that there was no evidence of an association between breast implants and these CTDs.
2003 Spain STOA Report to the European Parliament Petitions Committee Regarding new scientific evidence, the currently available information shows that there is not solid evidence linking SBI to severe diseases (such as breast cancer or connective tissue diseases). [5]

Thousands of women have still claimed that they have become ill from their implants. Complaints include systemic fungus, neurological and rheumatological problems. Neurology is a branch of medicine dealing with disorders of the nervous system. ... Rheumatology, a subspecialty of internal medicine, is devoted to the diagnosis and therapy of rheumatic diseases. ...


As studies have followed women with implants for a longer period of time, more information has been made available to assess these issues. A 2004 Danish study, reported that women who had breast implants for an average of 19 years were no more likely to report an excess number of rheumatic symptoms then control groups.[31] A large study of plastic surgery patients found a decreased standardized mortality ratio in both breast implant and other plastic surgery patients, but a relatively increased risk of lung cancer deaths in breast implant recipients compared to other forms of plastic surgery. The authors attributed this to differences in smoking rates.[78] Another large study of nearly 25,000 Canadian women with implants recently reported a 43 percent lower rate of breast cancer compared with the general population and a lower-than-average risk of developing cancer of any kind.[36] The standardized mortality ratio in epidemiology is the ratio of observed deaths to expected deaths in a population. ... Lung cancer is a disease of uncontrolled cell growth in tissues of the lung. ...


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You should refer to our breast implant consumer handbook, which is available on our FDA breast implant website at http://www.fda.gov/cdrh/breastimplants/, for a description of potential breast implant complications.
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