A breast implant is a prosthesis used to change the size, shape, and contour of a woman's breast. In reconstructive plastic surgery, breast implants can be placed to restore natural looking breast mounds for post-mastectomy breast reconstruction patients or to correct congenital defects and chest wall deformities. They are also used cosmetically to enhance or enlarge breast appearance through breast enlargement surgery.
There are three general types of breast implant devices , which are defined by their fillers: saline solution, silicone gel, and composite filler. Saline implants have elastomeric silicone skin filled with sterile saline solution during surgery; silicone implants have elastomeric silicone skin filled with thick silicone gel; and alternate arrangement arrangements display various fillers, such as soybean oil, polypropylene rope, etc. The combined implant is usually not recommended for reuse and, in fact, its use is prohibited in the United States and Europe due to health risks and related complications..
In surgical practice, for breast reconstruction, the expander tissue device is a temporary breast prosthesis used to form and make implantable pockets for permanent breast implants in the future. For the correction of deformities and male breast abnormalities, pectoral implants are breast prostheses used for the reconstruction and aesthetic improvement of a man's chest wall (see gynecomastia and mastopection).
Video Breast implant
History
19th century
Since the late nineteenth century, breast implants have been used for enlarging size (volume), modifying shapes (contours), and enhancing the taste (wisdom) of women's breasts. In 1895, surgeon Vincenz Czerny affected the earliest placement of breast implants when he used adipose autologous tissue of patients, harvested from benign lumbar lipoma, to correct the asymmetry of breast tumors that had been taken. In 1889, surgeon Robert Gersuny experimented with paraffin injections, with devastating results.
20th Century
From the first half of the twentieth century, doctors used other substances to fill the implants of ivory, glass balls, soil rubber, cow cartilage, Terylene wool, gutta percha, Dicora, polyethylene chips, Ivalon (polyvinyl alcohols - formaldehyde polymers). sponge), polyethylene pouch with Ivalon, polyether foam sponge (Etheron), polyethylene tape (Polystan) strips twisted into spheres, polyester (spongy polyurethane foam) Silicone rubber, and proton Teflon-silicon.
In the mid-twentieth century, Morton I. Berson, in 1945, and Jacques Maliniac, in 1950, each performed a flap-based breast enlargement by rotating the patient's chest wall tissue into the breast to increase the volume. Furthermore, throughout the 1950s and 1960s, plastic surgeons used synthetic fillers - including silicone injections received by about 50,000 women, from which developed silicone granulomas and hardening of the breast requiring treatment with a mastectomy. In 1961, American plastic surgeons Thomas Cronin and Frank Gerow, and Dow Corning Corporation, developed the first silicone breast prosthesis, filled with silicone gel; in time, the first augmentation mammoplasty was performed in 1962 using the Cronin-Gerow Implant, a 1963 model of prostheses. In 1964, the French company Arato Laboratoires developed and produced saline breast implants, filled with saline solution, and then introduced for use as a medical device in the year 1964.
Maps Breast implant
Type
Currently, there are two types of breast implants commonly used for mammoplasty procedures, breast reconstruction, and breast enlargement:
- saline implants are filled with sterile saline solution.
- silicone implant filled with thick silicone gel.
Saline implants
Saline breast implants - filled with saline solution (brine biological concentration 0.90% b/v NaCl, about 300 mOsm/L.) - were first produced by the company Arion Laboratoires, in France, and were introduced for use as a prosthetic medical device on 1964. The contemporary model of saline breast implants is made with a thicker, room-sized (RTV) shell made of silicone elastomers. Research In Vitro Deflated Saline Breast Implants (2006) reported that the deflation rate (filler leakage) of pre-filled saline breast implants made it a second-choice prosthesis for corrective breast. operation. Nevertheless, in the 1990s, saline breast implants were the most commonly used prosthesis tool for breast enlargement surgery in the United States, due to US FDA restrictions on implantation of silicone implants containing silicone outside clinical studies. Saline breast implants have enjoyed little popularity around the world, having a negligible market share.
The technical goal of saline-implant technology is a physically invasive surgical technique for placing an implantable breast implant device through a smaller surgical incision. In surgical praxis, after placing an empty breast implant into an implanted pouch, the plastic surgeon then fills each device with a salt solution, and, because the required incision insertion is short and small, the resulting incision scar will be smaller and shorter. rather than the usual surgical scar on the long incision required to insert a pre-filled silicone gel implant.
When compared to the results achieved with silicone-gel breast implants, saline implants can produce acceptable results, increased breast size, fine-cut contours, and realistic texture; however, it is more likely to cause cosmetic problems, such as ripples and wrinkles on the skin of breast envelopes, accelerated stretching of the breast, and technical problems, such as the presence of implants seen by the eye and touch.. The occurrence of such cosmetic problems is more likely in the case of women with very little breast tissue, and in cases of women requiring post-mastectomy breast reconstruction; thus, silicone-gel implants are technically superior prosthetic devices for breast enlargement, and for breast reconstruction. In the case of women with multiple breast tissues, for whom sub-muscular emplacement is the recommended surgical approach, saline breast implants can produce aesthetic results as provided by silicone breast implants, albeit with greater implant palpability.
Silicone gel implants
As medical device technology, there are five generations of silicone breast implants, each determined by common model manufacturing techniques.
Modern prosthetic breasts were discovered in 1961 by American plastic surgeons Thomas Cronin and Frank Gerow, and produced by Dow Corning Corporation; in time, the first augmentation mammoplasty was performed in 1962.
First generation
The Cronin-Gerow implant, a 1963 prosthesis model, is silicone rubber bags, shaped like teardrops, filled with thick silicone gel. To reduce rotation of breast implants resting on the chest wall, the 1963 model prosthesis is attached to an implanted pocket with a fastening patch, made of Dacron material (Polyethylene terephthalate), attached to the back of the breast implant shell.
Second generation
In the 1970s, manufacturers presented second-generation breast implant prostheses featuring functional growth and aesthetic improvements to technology:
- the first technological developments were thin-gauge shells, and low crystal silicone fillers, which enhanced the functionality and verisimilitude (size, appearance, and texture) of embedded silicone-gel breasts. However, in clinical practice, second-generation breast implants proved fragile, and experienced greater incidence of shell rupture, and filler leakage ("bloody silicone") through the whole device shell. As a result, the increased incidence rates of medical complications (eg capsular contractures) that cause product damage, class action lawsuits, by the US government, against Dow Corning Corporation, and other breast prosthesis producers.
- second technological developments are the polyurethane foam layer for breast implant shells; the layer reduces the incidence of capsular contracture, by causing an inflammatory reaction that inhibits the formation of fibrous collagen fibrous capsule around the breast implant. However, regardless of the size of the prophylaxis, the medical use of polyurethane coated breast implants is briefly discontinued, due to the potential health risks posed by 2,4-toluenediamine (TDA), a carcinogenic by-product of polyurethane chemical breakdown. layer of foam from breast implants.
- After reviewing medical data, the US Food and Drug Administration concluded that TDA-induced breast cancer is a very small risk for women with breast implants, and does not legally justify that doctors require to explain problem for their patients. In the event, polyurethane-coated breast implants remain in plastic surgery practice in Europe and in South America; and no manufacturer has requested FDA approval for such breast implant medical sales in the US.
- the third technological development is a double breast lumen implant device, a double cavity prosthesis consisting of a silicone breast implant embedded in a saline breast implant. Two, the technical objectives are: (i) the silicone-gel cosmetic benefits (inner lumen) enclosed in saline solution (outer lumen); (ii) a breast implant device whose volume may be adjusted postoperatively. However, the more complex designs of double-lumen breast implants experience a greater device failure rate than single-lumen breast implants. The contemporary version of a second-generation breast implant device (presented in 1984) is a Becker Expandable model of breast implants, which is primarily used for breast reconstruction.
- primary reconstruction: replacement of breast tissue damaged by trauma (blunt, penetrating, explosive), disease (breast cancer), and the development of a failed anatomy (tuberous breast deformity).
- revision and reconstruction: to revise (improve) the results of prior breast reconstruction surgery.
- Primary augmentation: aesthetically increases the size, shape, and taste of the breast.
- Inframammary: an incision made on the inframammary fold (a natural fold beneath your breast), which gives maximum access to tissue dissection and breast implant implants. This is the preferred surgical technique for the laying of silicone-gel implants, as it better exposes the breast-muscle tissue pectoralis interface; however, IMF implantation can produce thicker and slightly more visible scarring.
- Periareolar: borderline incision along the periphery of the areola, which provides an optimal approach when IMF position adjustment is required, or when mastopection (breast tightness) is inserted into the primary mammoplasty procedure. In periareolar emplacement, the incision is about half the medial (half inferior) of the areola ring. Silicone gel implants can be difficult to block through the periareolar incision, because the length is five centimeters (~ 5.0 cm) of the required access incision. Aesthetically, since scars are on the border of the areola (fringe), they are usually less visible than IMF incision scars in women with isola light pigment; when compared with a skin incision scar, the modified epithelium of the areolae is less susceptible to a hypertrophic (raised) scar. Transaxillary: the incision made to the axilla (axilla), from which the medial medullary tunnel, to place the implant, either bluntly or with an endoscope (an illuminated video camera), without producing a visible scar on the right breast; however, it is more likely to result in inferior asymmetry from the device-implant position. Therefore, surgical revision of transaxillary emplaced breast implants usually requires either an IMF incision or a periareolar incision.
- Transumbilical: trans-umbilical breast enlargement (TUBA) is a less common implant-emplacement technique in which the incision is in the umbilicus (navel), and the superior dissection tunnel, toward the breast. The TUBA approach enables the implantation of the breast without producing a visible scar on the right breast; but make the appropriate dissection and device-emplacement more technically difficult. The TUBA procedure is performed bluntly - without the endoscopic visual aid - and is unsuitable for the silicone gel attachment (pre-filled), because of the great potential to damage the breast implantation silicone elastomer shell during manual installation through a short incision (~ 2.0 cm) in the navel, and since the pre-filled silicone gel implants can not be compressed, and can not be inserted through a very small incision. Transabdominal: as in the TUBA procedure, in transabdominoplasty breast enlargement (TABA), breast implants are superiorly transmitted from the abdominal incision into an implantable blind split sac, while the patient simultaneously develops abdominoplasty.
Third Generation and Fourth
In the 1980s, the Third Generation and Fourth Generation implant device models were sequential advancements in manufacturing technology, such as elastomeric coated skin with decreased ble-gel (filler leak), and thicker (gel-enhanced) gel fillers. Sociologically, prosthetic breast producers then design and model the anatomy (natural breast) and shaped model (round, oval) that realistically matches the breasts and female body. The breast implanted breast implant model has a uniform textured surface, which reduces the rotation of the prosthesis inside the implant pocket; a round breast implant model is available in a smooth surface and textured surface type.
Fifth generation
Since the mid-1990s, the fifth generation of silicone-gel breast implants are made of highly cohesive high-strength silicone gel which largely eliminates the occurrence of filler leaks ("silicone gel bleeds") and the migration of silicone fillers from the implanted bag to other places in the female body. These implants are usually referred to as "gummy gummy breast implants" for their strong and sturdy consistency, similar to gummy candy. Studies Experiences with Cohesive silicone anatomical silicone cohesive prosthesis in Cosmetic and Reconstructive Breast Reconstruction Surgery (2004) and Silicone Breast Implants Cohesive Gel on Aesthetic and Reconstructive Breast Surgery [2005] reported low incidence rates of capsular and rupture contractures device-shell; and a greater degree of increased medical security and technical efficacy compared to early-stage breast implant equipment.
Psychology
Breast enlargement patients are usually a young woman whose personality profile shows psychological distress about her personal appearance and physical self-image, and history is criticized (teasing) about her aesthetic. Studies of Body Image on Breast Augmentation Patients (2003) and Body Dysmorphic Disorders and Cosmetic Surgery (2006) reported that women undergoing breast enlargement surgery have also undergone psychotherapy, suffering from low self, often presented psychological depression, have attempted suicide, and suffered from body dysmorphia, a type of mental illness.
Post-operative patient surveys on mental health and quality of life, reported improvements in physical health, physical appearance, social life, self-confidence, self-esteem, and satisfying sexual function. Furthermore, women reported long-term satisfaction with the results of their breast implants; some even have medical complications that require surgical revision, either correction or aesthetics. Similarly, in Denmark, 8.0 percent of breast enlargement patients have a pre-operative history in a mental hospital.
In 2008, longitudinal studies Excess mortality from suicide and other causes of external mortality among women with cosmetic breast implants (2007), reported that women seeking breast implants were almost 3.0 times more likely to commit suicide such as are women who are not looking for breast implants. Compared with standard suicide rates for women of the general population, suicide rates for women with enlarged breasts remained constant until 10-years postimplantation, however, increased to 4.5 times greater in the 11-year mark, and so on. remained until the 19-year mark, when it rose to 6.0 times greater in the 20-year post-implantation. In addition, in addition to the risk of suicide, women with breast implants also face the risk of death from alcoholism and abuse of prescription and recreational drugs. Although seven studies statistically linked breast enlargement of women to a greater suicide rate, studies have shown that breast enlargement surgery does not increase mortality rates; and that, in the first instance, is a psychopathologically inclined woman who is more likely to undergo breast enlargement procedures.
Study of Influence of Mammoplasty of Breast Enlargement on Self-Esteem and Sexuality: Quantitative Analysis (2007), reported that women attribute enhanced self-image, self-esteem, and enhancement, satisfactory sexual function to have experienced breast enlargement; group, aged 21-57 years, an average post-operative self-improvement increase ranging from 20.7 to 24.9 points on Rosenberg's self-esteem scale of 30 points, supported by a 78.6 percent increase in female libido, relative to libido levels pre-operation. Therefore, before approving any surgery, the plastic surgeon evaluates and considers the mental health of the woman to determine whether breast implants can positively affect her self-esteem and sexual function.
Surgical procedure
Indication
The mammoplasty procedure for placement of breast implant devices has three (3) objectives:
The operating room (OR) time of post-mastectomy breast reconstruction, and breast enlargement surgery is determined by the procedure used, type of incision, breast implants (types and materials), and pectoral location of the implant pocket.
Recent research suggests that mammograms should not be performed with increasing frequency than those used in normal procedures in patients undergoing breast surgery, including breast implants, augmentation, mastopection, and breast education.
Incise type
Breast implant planting was performed with five (5) types of surgical incisions:
Placement of the implanted pocket
Four surgical approaches to placing breast implants into an implanted pocket are described in an anatomical relationship with the major pectoral muscles. Subglandular: breast implants are attached to the retromammary space, between the breast tissue (mammary gland) and the main pectoral muscle (the main chest muscle), closest to the normal breast tissue area, and provide the most aesthetic results. However, in women with thin pectoral soft tissues, subglandular positions are more likely to show ripples and wrinkles in the underlying implants. In addition, the incidence of capsule contracture is slightly greater with subglandular implantation.
Post-operative recovery
Mammoplasty surgical scarring of breast enlargement develops approximately at 6 weeks postoperatively, and fades within a few months. Depending on the daily physical activity that women need, breast enlargement patients usually resume normal life at 1 week postoperatively. In addition, women whose breast implants are superimposed under the chest muscles (submuscular placement) usually have a longer, slightly more painful recovery, due to healing from the incision to the chest muscles. Usually, he does not exercise or engages in heavy physical activity for about 6 weeks. During early postoperative recovery, women are encouraged to regularly exercise (flex and move) their arms to reduce pain and discomfort; if necessary, analgesics in a drug catheter can relieve pain. In addition, patient recovery has significantly resulted from subtle, submuscular, subglandular implantation techniques that allow 95 percent of women to resume their normal life at 24-hour post-procedure, without bandages, channel fluids, pain pumps, catheters, medical support brassières, or narcotic pain medication.
Complications
The plastic surgery emplacement of breast implants, whether for breast reconstruction or for aesthetic purposes, presents the same general health risks for surgery, such as adverse reactions to anesthesia, hematoma (postoperative hemorrhage), end hematoma (after surgery after 6 months or more ), seroma (fluid accumulation), site-incision damage (infection wound). Specific complications for breast enlargement include breast tenderness, altered sensations, impaired breastfeeding, visible wrinkles, asymmetry, thinning of the breast tissue, and symmastia, the "loafbread" of breast disturbing the natural plane between breasts. Special treatments for deep breast implant complications - capsular contracture and capsular rupture - are MRI monitoring and periodic physical examination. Furthermore, complications and repeat surgeries associated with implantation surgery, and for tissue expansion (holders of implant sites during surgery) can cause unfavorable scarring in about 6-7 percent of patients. Statistically, 20 percent of women who underwent cosmetic implantation, and 50 percent of women who underwent breast implantation reconstruction, require their explanation on the 10-year mark.
Implanted damage
Since breast implants are class III medical devices from a limited product life, the major rupture level factors are age and design; However, breast implant devices can maintain their mechanical integrity for decades in the female body. When a saline breast implant breaks out, leaks, and empties, it rapidly deflates, and thus can easily be explored (surgically removed). The follow-up report, Natrelle Saline-filled Breast Implants: The 10-year Study of Candidates (2009) shows a 3-5 percent deflation rate in 3-year postimplantation, and a 7 -10 percent deflation rate split in 10-year post-implantation.
When silicone breast implants rupture usually do not deflate, but the gel filler does not leak, which can migrate to the implanted pouch; therefore, intracapsular rupture (leakage of the capsule) may be an extracapsular rupture (leakage outside the capsule), and each event is solved by explanation. Although leaking silicone gels may migrate from the chest tissue to other sites in the female body, most clinical complications are limited to the breast and armpit areas, usually manifested as granulomas (inflammatory nodules) and axillary lymphadenopathy (enlarged lymph nodes in the armpit area).
The mechanism of implanted breast implants ruptured is:
- damage during implantation
- damage during the (other) surgical procedure
- chemical degradation of breast implant shells
- trauma (blunt trauma, penetrating trauma, blast trauma)
- mechanical pressure from traditional mammography breast examination
Ruptured silicone implants can be evaluated using magnetic resonance imaging; from long-term MRI data for single-lumen breast implants, European literature on second generation silicone-gel breast implants (1970s design), reported a loss of 8-15 percent of stationary damage in 10-year post-implantation (15- 30% of patients).
This Study The Security and Effectiveness of MemoryGel Mentor Implants at 6 Years (2009), which is a branch study of the FDA's core US core clinical trials for primary breast enlargement surgery patients, reported a low-loss device level of 1.1 percent at 6 post-implantation years. The first series of MRI evaluations of silicone breast implants with thick filler gel reported a device break-up rate of 1.0 percent, or less, at a median of 6-year-old device. Statistically, a woman's manual (palpation) check is not sufficient to accurately evaluate if breast implants have broken. Research, <<> Diagnosis of Silicone Breast Implant Implantation: Clinical Findings Compared to Findings in Magnetic Resonance Imaging (2005), reported that, in asymptomatic patients, only 30 percent of broken breast implants were accurately palpated. and was detected by experienced plastic surgeons, while the MRI examination accurately detected 86 percent of broken breast implants. Therefore, the US FDA recommends a scheduled MRI examination, as the scanning is cracked, beginning in post-implantation 3 years, and then every two years, thereafter. Nevertheless, outside the US, medical companies in other countries have not supported routine MRI checks, and, instead, propose that such radiological examinations be conducted for two purposes: (i) for women suspected of having breast implants; and (ii) to confirm mammography and ultrasonic studies indicating the presence of broken breast implants.
Furthermore, the effect of Bias Study design on the accuracy of magnetic resonance diagnostic imaging for detection of silicone breast implants (Meta-analysis) (2011) reported that breast-screening breast MRI asymptomatic women may overestimate the incidence of breast implant rupture. In the event, the US Food and Drug Administration stressed that "breast implants are not lifelong devices, the longer a woman has breast implants containing silicone gel, the more likely she is to have complications."
Capsular contracture
The human immune response to foreign objects that are surgically implanted - breast implants, pacemakers, orthopedic prostheses - is to wrap it with capsules of scar tissue from tightly bound collagen fibers, to maintain the integrity of the body by isolating foreign bodies. object, and tolerate its presence. Capsular contracture - which must be distinguished from normal capsular tissue - occurs when collagen-fiber capsules thicken and compress breast implants; it is a painful complication that may distort breast implants, or breasts, or both.
The cause of capsular contracture is unknown, but common incident factors include bacterial contamination, rupture of the device's shell, filler leakage, and hematoma. Surgical implantation procedures that have reduced the incidence of capsular contracture include submuscular emplacement, use of breast implants with textured surfaces (layered polyurethane); limited pre-operative implant handling, limited contact with breast skin from implanted pockets before breast implant implants, and irrigation from the receiving site with triple-antibiotic solution.
Corrective capsular contractures may require open capsulotomy (surgical removal) of collagen fiber capsules, or removal, and possible replacement, breast implants. Furthermore, in treating capsular contracture, closed capsulotomy (a disturbance through external manipulation) was once a common maneuver to treat hard capsules, but now is a technique not recommended, as it may damage breast implants. Non-surgical treatments for collagen-fiber capsules include massage, external ultrasound therapy, leukotriene line inhibitors such as zafirlukast (Accolate) or montelukast (Singulair), and pulsed electromagnetic field therapy (PEMFT).
Operation repair and revision
When patients are dissatisfied with mammoplasty augmentation results; or when technical or medical complications occur; or because of the limited product life of the breast implant, it is likely that she needs to replace breast implants. Surgical indications of general revision include major and minor medical complications, capsular contracture, shell rupture, and deflation of the device. The incidence rate of revision is greater for breast reconstruction patients, due to post-mastectomy changes to the soft tissues and to the skin of the breast envelope, and the anatomical border of the breast, especially in women receiving adjuvant external radiation therapy. In addition, in addition to breast reconstruction, breast cancer patients typically undergo revision surgery of the nipple-areola complex (NAC), and symmetry procedures in opposite breasts, to create a natural appearance, size, shape, and nuance. Carefully matching the type and size of breast implants with pectoral soft tissue characteristics of patients will reduce the incidence of revision surgery. Appropriate network matching, implant selection, and implantation techniques are appropriate, the re-operation rate is 3.0 percent on the 7-year mark, compared with a 20 percent repeat rate on the 3-year mark, as reported by the US Food and Drug Administration.
Systemic Disease and ALCL Cancer
Systemic diseases and diseases
Many women with breast implants have reported connective tissue diseases such as systemic sclerosis, systemic lupus erythematosus, rheumatoid arthritis, and fibromyalgia. Various other systemic symptoms have been widely demonstrated and fall under the term Breast Disease Implant. Symptoms include extreme fatigue, cognitive dysfunction (brain fog, memory loss, difficulty concentrating), joint and muscle pain, dryness throughout the body, hair loss, tingling and numbness in the extremities, recurrent infections, endocrine problems (thyroid, adrenal, ) ), and others.
Platinum Poisoning
Platinum is used in the production of silicone gel for breast implants and small quantities can seep into the surrounding tissue. Dr. Ernest Lykissa and Dr. Susan Maharaj did research on breast and platinum silicone implants. In their Analytical Chemistry paper, which is the top journal in the field, they reported finding the highest platinum to date in women who have an implant. They also found that platinum turned into a more dangerous oxidizing state.
Anaplastic large cell lymphoma
The FDA has identified that breast implants may be associated with a rare form of cancer called anaplastic large cell lymphoma, believed to be associated with chronic bacterial inflammation. Similar ALCL phenomena have been seen with other types of medical implants including vascular access ports, orthopedic hip implants, and jaw implants (TMJ). On February 1, 2017, the FDA has received a total of 359 medical device reports from breast implant-related ALCL (BIALCL), including 9 deaths. Most cases of breast implants associated ALCL have implants for many years prior to the condition, and are usually successfully treated by the removal of simple implants and capsules around the implant without the need for chemotherapy if there is no evidence of systemic disease. If women with implants present with swelling or delayed fluid collection, cytologic examinations and tests for "CD30" markers are recommended. The American Society of Plastic Surgery (ASPS) states, "CD30 is the major diagnostic test that should be performed on serum fluids as routine pathology or H & E staining can often lose diagnosis." The diagnosis and treatment of breast implants related to ALCL now follow the standard guidelines established by the National Comprehensive Cancer Network.
Current life-long BIA-ALCL risk in the US is unknown, but estimates range from between 1 in 70,000 to 1 in 500,000 women with breast implants according to MD Anderson. Certain geographic locations have indicated variable risk. For example, December 2016 updates from the Australian and New Zealand Goods Treatment Administration report risks of 1: 1,000 to 1: 10,000 for textured implants. "Until now (2017), there has not been a case of BIAL reporting where the patient was only implanting a soft-shell breast implant or a textured tissue expander exchanged with fine implants.The reported case deficiency in the Asian population has increased the possibility that there may be a genetic range, a vulnerability to a phenomenon, or simply reflect differences in how cases are identified and reported.
ASPS and the Plastic Surgery Foundation (PSF) have partnered with the FDA to study this condition and thereby create the Patient Registry and Results For Breast Implants and Large Lymphoma Etiology and Epidemiology (PROFIL) Lymphoma Cells. The FDA of the United States strongly encourages all doctors to report cases to PROFIL in an effort to better understand the role of breast implants in ALCL and the management of this disease.
Implants and breastfeeding
Digestive contamination and systemic toxicity are major infant health problems; leakage of breast implants to breast milk, and if the filler is harmful to breastfeeding infants. The biologically implantable breast implant device filler is salt water, and the silicone filler can not be digested - because of any inert chemical, and general environment. In addition, support physicians say that "there should be no absolute contraindication to breastfeeding by women with silicone breast implants." In the early 1990s, early in the incidence of silicone breast implant disease, small-scale, non-randomized studies (ie "patients present with complaints, which may have multiple sources", not "doctors performing random tests") suggests breast-feeding possibilities complications from silicone implants; but no studies have reported disease-causality causality.
Women with breast implants may have difficulty in functional breastfeeding; The mammoplasty procedure featuring periareolar incisions is very likely to cause difficulty in breastfeeding. Surgery can also damage the lactiferous ducts and nerves in the nipple-areola area.
Functional breastfeeding difficulties arise if the surgeon cuts the milk ducts or the major nerves that conserve the breast, or if the mammary gland is declared damaged. Dairy channels and nerve damage are more common if the incision cuts the tissue near the nipple. The milk glands are most likely to be affected by subglandular implants (under the gland), and with large-sized breast implants, which pinch the lactiferous channels and inhibit the flow of milk. Small breast implants, and submuscular implantation, cause fewer breast function problems; However, it is not possible to predict whether a woman who has breast augmentation will be able to successfully breastfeed because some women can breastfeed after periareolar incisions and subglandular placements and some can not after augmentation using submuscular and other types of surgical incisions.
Implants and mammography
The presence of impervious radiological breast implants (either saline or silicon) may interfere with the radiographic sensitivity of the mammography, ie, the images may not indicate an existing tumor. In this case, the Eklund mammogram sees necessary to ascertain whether or not there is a cancerous tumor, in which the breast implants are manually transferred to the chest wall and the breast is pulled forward, so that mammography can visualize larger volumes. of the internal network; However, about one-third of breast tissue remains not adequately visualized, resulting in an increased incidence of mammograms with false-negative results.
Breast Cancer Study on Augmented Breast: Diagnosis and Prognosis (1993) and Breast Cancer after Augmentation Mammoplasty (2001) of women with breast implanted prosthesis reported no significant difference in stage of the disease at the time of cancer diagnosis; prognosis is similar in both groups of women, with patients being enlarged at a lower risk for cancer recurrence or subsequent death. In contrast, the use of implants for breast reconstruction after breast cancer mastectomy did not appear to have a negative effect on cancer-related deaths. That patients with breast implants are more often diagnosed with palpable - but not greater - tumors suggest that tumors of the same size may be more palpable in an enlarged patient, which may compensate for a disturbed mammogram image. Palpability of breast-cancer-ready tumors is the result of thinning of the breast tissue by compression, by default in smaller breasts a priori (because they have lower tissue volume), and that the implants function as a radio- opaque where cancerous tumors can be distinguished.
Breast implants have no clinical cushion on lumpectomy breast enlargement surgery for women with breast cancer after implantation procedures, as well as breast implants interfering with external radiation (XRT) treatments; In addition, the incidence of post-treatment of breast tissue fibrosis is common, and thus a consequent increase in the level of capsular contracture. Research on Breast Cancer Detection and Survival among Women with Cosmetic Breast Implants: A Systematic Review and Meta-analysis from Observational Studies , reported a significant delay in the diagnosis of women who developed breast cancer after undergoing breast enlargement, when compared with breast cancer patients who have not experienced breast enlargement. Breast Implant Study Following Mastectomy in Women with Breast Cancer Early Stage: Prevalence and Impact on Survival (2005) reported that breast augmentation patients were statistically more likely to die from breast cancer. Although the use of implants for breast reconstruction after breast cancer mastectomy does not appear to have a negative effect on cancer-related deaths, women undergoing mastectomy procedures tend to die earlier than women undergoing lumpectomy. procedures, with such diagnosis.
AS. FDA Approval
In 1988, twenty-six years after the introduction of breast implants in 1962 filled with silicone gel, the US Food and Drug Administration (FDA) investigated the failure of breast implants and subsequent complications, and reclassified breast implant devices as Class III medical devices, and is required from documentary data manufacturers who reinforce the safety and efficacy of their breast implant devices. In 1992, the FDA placed silicone-gel breast implants in a moratorium in the US, as there was "insufficient information to show that breast implants are safe and effective". Nonetheless, medical access to a silicone-gel breast implant device continues for clinical studies of post-mastectomy breast reconstruction, congenital defect correction, and replacement of broken silicon-gel implants. The FDA requires from manufacturers of clinical trial data, and allows them to provide breast implants for breast enlargement patients for statistical studies required by the US Food and Drug Administration. In mid-1992, the FDA approved additional research protocols for silicone filled implants for breast reconstruction patients, and for revision surgery patients. Also in 1992, Dow Corning Corporation, a silicone product and breast implant manufacturer, announced the discontinuance of five implantable silicon grade silicon, but will continue to produce 45 other medical grade silicon materials - three years later, in 1995, Dow Corning Corporation went bankrupt when faced a large class lawsuit that claims various diseases. In 1997, the US Department of Health and Human Services (HHS) appointed the Institute of Medicine (IOM) of the US National Academy of Sciences (NAS) to investigate the potential risks of surgical and postoperative complications from silicone breast implants implants. The IOM's review of the safety and efficacy of breast implants containing silicone gel, reported that "evidence suggests illness or conditions, such as connective tissue disease, cancer, neurological disease, or other systemic complaints or conditions that are no more common in women with breast implants than in women without implants "subsequent studies and systemic review found no causal association between implants and silicone breast disease.
- In 1998, the US FDA approved additional study protocols for silicone filled implants only for breast reconstruction patients and for revision surgery patients; and also approved Dow Corning Corporation's Investigational Device Exemption (IDE) study for silicone-gel breast implants for a number of breast enlargement, reconstruction, and revision-limited patients.
- In 1999, the Institute of Medicine published a study of Silicone Breast Implant Security (1999) which reported no evidence that breast implanted devices filled with saline and silicone gel caused systemic health problems; that its use does not pose any new health or safety risks; and that local complications are a "major safety issue with silicone breast implants," in distinguishing between routine and local medical complications and systemic health problems. "
- In 2000, the FDA approved a salary copy implant of the Premarket Approval App (PMA) containing the type and data on the level of local medical complications experienced by breast surgery patients. "Despite the complications experienced by some women, the majority of women still in the study of Inamed Corporation and Mentor Corporation, after three years, report satisfied with their implants." Premarket approval is given for breast enlargement, for women at least 18 years, and for women who need breast reconstruction.
- In 2006, for Inamed Corporation and for Mentor Corporation, the US Food and Drug Administration lifted restrictions on the use of silicone-gel breast implants for breast reconstruction and for augmentation mammoplasty. However, the approval was conditional upon receiving FDA monitoring, completion of a 10-year study of women who already had breast implants, and a second completion, a 10-year study of breast implant safety in 40,000 other women. The FDA warns the public that breast implants do carry medical risks, and recommend that women undergoing breast enlargement regularly undergo MRI examinations to screen for signs of shrunken or filler leakage, or both conditions; and ordered that breast surgery patients be given detailed and informative brochures explaining the medical risks of using silicone-gel breast implants.
The US Food and Drug Administration sets the age range for women seeking breast implants; for breast reconstruction, silicone filled implants and salt-filled implants are approved for women of all ages; for breast enlargement, saline implants are approved for women aged 18 years and older; silicone implants approved for women 22 years and older. Because each breast implant device has different medical risks, the patient's minimum age for saline breast implants is different from the patient's minimum age for silicone breast implants - due to filler leakage and the risk of silent membrane shells; thus, periodic MRI screening examinations are recommended post-operative therapy for patients. In other countries, in Europe and Oceania, the national health ministry's breast implant policy does not support periodic MRI examination in asymptomatic patients, but suggests a proper palpation - with or without ultrasonic screening - to be sufficient post-operative therapy for the majority of patients. patient.
Breast Implant Security
In the early 1990s, the national health departments of the listed countries reviewed related studies for the causal relationship between silicone-gel breast implants and systemic and auto-immune diseases. The common conclusion is that there is no evidence to suggest a causal relationship between implantation of breast implants and silicone type of disease. Danish Studies Danish Women Long Term Health Status with Silicone Breast Implants (2004) reported that women who had an average breast implant of 19 years were no more likely to report an excess of rheumatic disease. symptoms than women from the control group. Further studies of mortality rates among patients with mammoplasty Augmentation: Updates (2006) reported a decrease in the standard mortality ratio and an increased risk of lung cancer mortality among breast implant patients, compared among patients for other types of plastic surgery; the difference in mortality rates associated with smoking tobacco. Mortality among Canadian Women with Cosmetic Breast Implants (2006), about 25,000 women with breast implants, reported a 43 percent lower breast cancer rate among them than among the general public, and lower. - the average risk of cancer.
See also
References
External links
- The basics of implant-based breast reconstruction (E-medicine)
- Institute of Medicine (IOM) Report on Silicon Implants
- US. Food and Drug Administration (FDA) - breast implant page
- U.K. Drug & amp; Health Care Products Body Regulator (MHRA) - breast implants page
- Australian Department of Health & amp; Aging Therapeutic Goods Administration breast implant page
- What you need to know about breast implants by National Center for Health Research
Source of the article : Wikipedia
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