Breast implant

Prosthesis used to change the size, shape, and contour of a person's breast

A breast implant is a prosthesis used to change the size, shape, and contour of a person's breast. In reconstructive plastic surgery, breast implants can be placed to restore a natural looking breast following a mastectomy, to correct congenital defects and deformities of the chest wall or, cosmetically, to enlarge the appearance of the breast through breast augmentation surgery. Complications of implants may include breast pain, rashes, skin changes, infection, rupture, cosmetic changes to the breasts such as asymmetry and hardness, and a fluid collection around the breast. A rare complication associated with textured surfaced implants is a type of lymphoma (cancer of the immune system) known as breast implant associated anaplastic large cell lymphoma (BIA ALCL). There are four general types of breast implants, defined by their filler material: saline solution, silicone gel, structured and composite filler. The saline implant has an elastomer silicone shell filled with sterile saline solution during surgery; the silicone implant has an elastomer silicone shell pre filled with viscous silicone gel; structured implants use nested elastomer silicone shells and two saline filled lumen; and the alternative composition implants featured miscellaneous fillers, such as soy oil or polypropylene string. In surgical practice, for the reconstruction of a breast, the tissue expander device is a temporary breast prosthesis used to form and establish an implant pocket for the future permanent breast implant. For the correction of male breast defects and deformities, the pectoral implant is the breast prosthesis used for the reconstruction and the aesthetic repair of a man's chest wall (see: gynecomastia and mastopexy).

The breast augmentation patient usually is a young woman whose personality profile indicates psychological distress about her personal appearance and her bodily self image, and a history of having endured criticism (teasing) about the aesthetics of her person. The studies Body Image Concerns of Breast Augmentation Patients (2003) and Body Dysmorphic Disorder and Cosmetic Surgery (2006) reported that the woman who underwent breast augmentation surgery also had undergone psychotherapy, suffered low self esteem, presented frequent occurrences of psychological depression, had attempted suicide, and had body dysmorphia, a type of mental illness. Post operative patient surveys about mental health and quality of life, reported improved physical health, physical appearance, social life, self confidence, self esteem, and satisfactory sexual functioning. Furthermore, the women reported long term satisfaction with their breast implant outcomes; some despite having medical complications that required surgical revision, either corrective or aesthetic. Likewise, in Denmark, 8% of breast augmentation patients had a pre operative history of psychiatric hospitalization. In 2008, the longitudinal study Excess Mortality from Suicide and other External Causes of Death Among Women with Cosmetic Breast Implants (2007), reported that women who sought breast implants are almost 3 times as likely to commit suicide as are women who have not sought breast implants. Compared to the standard suicide rate for women of the general populace, the suicide rate for women with augmented breasts remained constant until 10 years post implantation, yet, it increased to 4.5 times greater at the 11 year mark, and so remained until the 19 year mark, when it increased to 6 times greater at 20 years post implantation. Moreover, additional to the suicide risk, women with breast implants also faced a trebled death risk from alcoholism and the abuse of prescription and recreational drugs. Although seven studies have statistically connected a woman's breast augmentation to a greater suicide rate, the research indicates that breast augmentation surgery does not increase the death rate; and that, in the first instance, it is the psychopathologically inclined woman who is more likely to undergo a breast augmentation procedure. The study Effect of Breast Augmentation Mammoplasty on Self Esteem and Sexuality: A Quantitative Analysis (2007), reported that the women attributed their improved self image, self esteem, and increased, satisfactory sexual functioning to having undergone breast augmentation; the cohort, aged 21–57 years, averaged post operative self esteem increases that ranged from 20.7 to 24.9 points on the 30 point Rosenberg self esteem scale, which data supported the 78.6 per cent increase in the woman's libido, relative to her pre operative level of libido. Therefore, before agreeing to any surgery, the plastic surgeon evaluates and considers the woman's mental health to determine if breast implants can positively affect her self esteem and sexual functioning.

The plastic surgical emplacement of breast implant devices, either for breast reconstruction or for aesthetic purpose, presents the same health risks common to surgery, such as adverse reaction to anesthesia, hematoma (post operative bleeding), late hematoma (post operative bleeding after 6 months or more), seroma (fluid accumulation), incision site breakdown (wound infection). Complications specific to breast augmentation include breast pain, altered sensation, impeded breast feeding function, visible wrinkling, asymmetry, thinning of the breast tissue, and symmastia, the "bread loafing" of the bust that interrupts the natural plane between the breasts. Specific treatments for the complications of indwelling breast implants—capsular contracture and capsular rupture—are periodic MRI monitoring and physical examinations. Furthermore, complications and re operations related to the implantation surgery, and to tissue expanders (implant place holders during surgery) can cause unfavorable scarring in approximately 6–7 percent of the patients. Statistically, 20 percent of women who underwent cosmetic implantation, and 50 percent of women who underwent breast reconstruction implantation, required their explantation (surgical removal) at the 10 year mark.

The human body's immune response to a surgically installed foreign object—breast implant, cardiac pacemaker, orthopedic prosthesis—is to encapsulate it with scar tissue capsules of tightly woven collagen fibers, in order to maintain the integrity of the body by isolating the foreign object, and so tolerate its presence. Capsular contracture—which should be distinguished from normal capsular tissue—occurs when the collagen fiber capsule thickens and compresses the breast implant; it is a painful complication that might distort either the breast implant, or the breast, or both. Capsular contracture is diagnosed through a visual and physical examiniation according to level of increasing severity based on the Baker Grade scale: Baker Grade I, Baker Grade II, Baker Grade III, and Baker Grade IV. The cause of capsular contracture is unknown, but the common incidence factors include bacterial contamination, device shell rupture, filler leakage, and hematoma. The surgical implantation procedures that have reduced the incidence of capsular contracture include submuscular emplacement, the use of breast implants with a textured surface (polyurethane coated); limited pre operative handling of the implants, limited contact with the chest skin of the implant pocket before the emplacement of the breast implant, and irrigation of the recipient site with triple antibiotic solutions. The correction of capsular contracture might require an open capsulotomy (surgical release) of the collagen fiber capsule, or the removal, and possible replacement, of the breast implant. Furthermore, in treating capsular contracture, the closed capsulotomy (disruption via external manipulation) once was a common maneuver for treating hard capsules, but now is a discouraged technique, because it can rupture the breast implant. Non surgical treatments for collagen fiber capsules include massage, external ultrasonic therapy, leukotriene pathway inhibitors such as zafirlukast (Accolate) or montelukast (Singulair), and pulsed electromagnetic field therapy (PEMFT).

When the patient is unsatisfied with the outcome of the augmentation mammoplasty; or when technical or medical complications occur; or because of the breast implants' limited product life, it is likely she might require replacing the breast implants. Common revision surgery indications include major and minor medical complications, capsular contracture, shell rupture, and device deflation.

In the 1990s, the national health ministries of the listed countries reviewed the pertinent studies for causal links among silicone gel breast implants and systemic and diagnosed autoimmune diseases and breast cancer. A study by researchers at the U. S. National Institute of Health reported an increase in four types of cancer among women with breast implants compared to other plastic surgery patients of the same age and similar demographic traits and health habits. A study by Watad et al. evaluated the medical records of more than 24,000 women with breast implants compared to more than 98,000 women with the same demographic traits who did not have breast implants. The researchers found a statistically significant 22 percent increase in several diagnosed diseases, increasing to more than 60% for Sjogren's syndrome, multiple sclerosis, and sarcoidosis After investigating this issue, in 2021 the U. S. FDA revised its "black box warnings" on breast implants to acknowledge the association between breast implants and systemic autoimmune, rheumatologic, and neurological symptoms to state: "Patients receiving breast implants have reported a variety of systemic symptoms, such as joint pain, muscle aches, confusion, chronic fatigue, autoimmune diseases, and others. Individual patient risk for developing these symptoms has not been well established. Some patients report complete resolution of symptoms when the implants are removed without replacement". A 2021 study by Cleveland Clinic physicians investigated the outcome of breast implant removal on women with breast implants who had reported difficulty breathing or tightness in their chest; this is one of the symptoms associated with breast implant illness. The study examined breast implant patients who reported problems breathing, comparing their scores on 6 pulmonary function tests before and after their implants and scar capsules were removed. The researchers reported that 74% of the patients reported significant improvements on at least 3 of the pulmonary function tests. In self reports, all study participants reported that their breathing improved after their implant surgery.

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. The FDA revisited this study and additional literature several years later, reaffirming prior conclusions that platinum catalysts used in implants is likely not ionized and therefore would not represent a risk to women.

The FDA has identified that breast implants may be associated with a rare form of cancer called anaplastic large cell lymphoma (ALCL), which some experts believe is 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 (TMJ) implants. The causal association between breast implants and ALCL was conclusively established in December 2013, when researchers at MD Anderson Cancer Center published a study of 60 women with breast implants who were diagnosed with ALCL in the breast. In 2015, plastic surgeons published an article reviewing 37 articles in the literature on 79 patients and collected another 94 unreported cases, resulting in 173 women with breast implants who had developed ALCL of the breast. They concluded that "Breast implant associated ALCL is a novel manifestation of site and material specific lymphoma originating in a specific scar location, presenting a wide array of diverse characteristics and suggesting a multifactorial cause." They stated that "There was no preference for saline or silicone fill or for cosmetic or reconstructive indications." Where implant history was known, the patient had received at least one textured surface device. In 2016, the World Health Organization (WHO) officially recognized BIA ALCL. As of April 2022, the FDA has received 1,130 global medical device reports (MDRs) of BIA ALCL, including 59 deaths. Since ALCL was thought to be diagnosed in only 1 woman in half a million, 60 women was a much higher number than would be expected. The researchers pointed out that BIA ALCL could be fatal. If women with implants present with delayed swelling or fluid collection, cytologic studies and a test for the marker CD30 are suggested. The American Society of Plastic Surgery (ASPS) states, "CD30 is the main diagnostic test that must be performed on the seroma fluid as routine pathology or H&E staining can frequently miss the diagnosis." Diagnosis and treatment of breast implant associated ALCL now follows standardized guidelines established by the National Comprehensive Cancer Network. The current lifetime risk of BIA ALCL in the U. S. is unknown, but estimates have ranged between one in 70,000 and one in 500,000 women with breast implants, according to the MD Anderson Cancer Center. Countries with breast implant registries have the best data on the risks of BIA ALCL. For example, as of October 2020, the Therapeutic Goods Administration of Australia and New Zealand reported a "1:3,345 risk with Allergan Biocell and a 1:86,029 risk with Mentor Siltex." Almost all those women had Allergan biocell implants and expanders. These reports strongly suggest that BIA ALCL develops primarily in patients with textured implants or expanders. In all cases, however, many researchers suspect that BIA ALCL is an under recognized, misdiagnosed, and under reported complication of breast implants. The ASPS and the Plastic Surgery Foundation (PSF) have partnered with the FDA to study this condition and in doing so created the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE). The United States FDA strongly encourages all physicians to report cases to PROFILE in an effort to better understand the role of breast implants in ALCL and the management of this disease.

In September, 2022, the FDA announced new information regarding other types of cancers related to breast implants, based on medical device reports (MDRs) of cases of patients with squamous cell carcinoma or various lymphomas found in the scar tissue around breast implants. The agency reported 10 MDRs about squamous sell carcinoma found in the capsule scar tissue and 12 MDRs about various lymphomas also in the scar tissue around the breast implants. These new cases do not overlap with cases of  BIA ALCL. SCC and other lymphomas have been found in smooth surface and textured implants as well as silicone gel filled and saline filled implants. Patients who reported symptoms specified swelling, pain, lumps, and changes to their skin. As of 2022, neither the incidence rate nor prevalence is known.

The five surgical approaches to emplacing a breast implant to the implant pocket are often described in anatomical relation to the pectoralis major muscle. Subglandular: the breast implant is emplaced to the retromammary space, between the breast tissue (the mammary gland) and the pectoralis major muscle (major muscle of the chest), which most approximates the plane of normal breast tissue, and affords the most aesthetic results. Yet, in women with thin pectoral soft tissue, the subglandular position is likelier to show the ripples and wrinkles of the underlying implant. Moreover, the capsular contracture incidence rate is slightly greater with subglandular implantation. Subfascial: the breast implant is emplaced beneath the fascia of the pectoralis major muscle; the subfascial position is a variant of the subglandular position for the breast implant. The technical advantages of the subfascial implant pocket technique are debated; proponent surgeons report that the layer of fascial tissue provides greater implant coverage and better sustains its position. Subpectoral (dual plane): the breast implant is emplaced beneath the pectoralis major muscle, after the surgeon releases the inferior muscular attachments, with or without partial dissection of the subglandular plane. Resultantly, the upper pole of the implant is partially beneath the pectoralis major muscle, while the lower pole of the implant is in the subglandular plane. This implantation technique achieves maximal coverage of the upper pole of the implant, whilst allowing the expansion of the implant's lower pole; however, "animation deformity", the movement of the implants in the subpectoral plane can be excessive for some patients. Submuscular: the breast implant is emplaced beneath the pectoralis major muscle, without releasing the inferior origin of the muscle proper. Total muscular coverage of the implant can be achieved by releasing the lateral muscles of the chest wall—either the serratus muscle or the pectoralis minor muscle, or both—and suturing it, or them, to the pectoralis major muscle. In breast reconstruction surgery, the submuscular implantation approach effects maximal coverage of the breast implants. This technique is rarely used in cosmetic surgery due to high risk of animation deformities. Prepectoral or subcutaneous: in a breast reconstruction following a skin sparing or skin and nipple sparing mastectomy, the implant is placed above the pectoralis major muscle without dissecting it so that the implant fills directly the volume of the mammary gland that has been removed. To avoid the issue of capsular contracture, the implant is often covered frontally or completely with a mesh in biomaterial, either biological or synthetic.

The surgical scars of a breast augmentation mammoplasty develop approximately at 6 weeks post operative, and fade within months. Depending upon the daily life physical activities required of the woman, the breast augmentation patient usually resumes her normal life at 1 week post operative. Moreover, women whose breast implants were emplaced beneath the chest muscles (submuscular placement) usually have a longer, slightly more painful convalescence, because of the healing of the incisions to the chest muscles. Usually, she does not exercise or engage in strenuous physical activities for approximately 6 weeks. During the initial post operative recovery, the woman is encouraged to regularly exercise (flex and move) her arm to alleviate pain and discomfort; if required, analgesic indwelling medication catheters can alleviate pain Moreover, significantly improved patient recovery has resulted from refined breast device implantation techniques (submuscular, subglandular) that allow 95 per cent of women to resume their normal lives at 24 hours post procedure, without bandages, fluid drains, pain pumps, catheters, medical support brassières, or narcotic pain medication.

The saline breast implant—filled with saline solution (biological concentration salt water 0.90% w/v of NaCl, ca. 300 mOsm/L. )—was first manufactured by the Laboratoires Arion company, in France, and was introduced for use as a prosthetic medical device in 1964. The contemporary models of saline breast implant are manufactured with thicker, room temperature vulcanized (RTV) shells made of a silicone elastomer. The study In vitro Deflation of Pre filled Saline Breast Implants (2006) reported that the rates of deflation (filler leakage) of the pre filled saline breast implant made it a second choice prosthesis for corrective breast surgery. In surgical praxis, after having emplaced the empty breast implants to the implant pockets, the plastic surgeon then filled each device with saline solution, and, because the required insertion incisions are short and small, the resultant incision scars will be smaller and shorter than the surgical scars usual to the long incisions required for inserting pre filled, silicone gel implants. When compared to the results achieved with a silicone gel breast implant, the saline implant can yield acceptable results, of increased breast size, smoother hemisphere contour, and realistic texture; yet, it is likelier to cause cosmetic problems, such as the rippling and the wrinkling of the breast envelope skin, accelerated lower breast pole stretch, and technical problems, such as the presence of the implant being noticeable to the eye and to the touch. The occurrence of such cosmetic problems is likelier in the case of the woman with very little breast tissue, and in the case of the woman who requires post mastectomy breast reconstruction; thus, the silicone gel implant is the technically superior prosthetic device for breast augmentation, and for breast reconstruction. In the case of the woman with much breast tissue, for whom sub muscular emplacement is the recommended surgical approach, saline breast implants can produce an aesthetic result much like that afforded by silicone breast implants. Ultrasound examination and outcome studies have revealed that saline and silicone breast implants look and feel similar.

As a medical device technology, there are five generations of silicone breast implant, each defined by common model manufacturing techniques. The modern prosthetic breast was invented in 1961 by the American plastic surgeons Thomas Cronin and Frank Gerow, and manufactured by the Dow Corning Corporation; in due course, the first augmentation mammoplasty was performed in 1962.

The Cronin–Gerow Implant, prosthesis model 1963, was a silicone rubber envelope sac, shaped like a teardrop, which was filled with viscous silicone gel. To reduce the rotation of the emplaced breast implant upon the chest wall, the model 1963 prosthesis was affixed to the implant pocket with a fastener patch, made of Dacron material (Polyethylene terephthalate), which was attached to the rear of the breast implant shell.

In the 1980s, the models of the third and of the fourth generations of breast implant devices were sequential advances in manufacturing technology, such as elastomer coated shells that decreased gel bleed (filler leakage), and a thicker (increased cohesion) filler gel. Sociologically, the manufacturers of prosthetic breasts then designed and made anatomic models (natural breast) and shaped models (round, tapered) that realistically corresponded with the breast and body types of women. The tapered models of breast implant have a uniformly textured surface, which reduces the rotation of the prosthesis within the implant pocket; the round models of breast implant are available in smooth surface and textured surface types.

Since the mid 1990s, the fifth generation of silicone gel breast implant is made of a high strength, highly cohesive silicone gel that mostly eliminates the occurrences of filler leakage ("silicone gel bleed") and of the migration of the silicone filler from the implant pocket to elsewhere in the woman's body. These implants are commonly referred to as "gummy bear breast implants" for their firm, pliant consistency, which is similar to gummy candies. The studies Experience with Anatomical Soft Cohesive Silicone gel Prosthesis in Cosmetic and Reconstructive Breast Implant Surgery (2004) and Cohesive Silicone gel Breast Implants in Aesthetic and Reconstructive Breast Surgery (2005) reported low incidence rates of capsular contracture and of device shell rupture; and greater rates of improved medical safety and technical efficacy than that of early generation breast implant devices.

The presence of breast implants currently presents no contraindication to breast feeding, and no evidence to support that the practice may present health issues to a breast feeding infant is recognized by the USFDA. Women with breast implants may have functional breast feeding difficulties; mammoplasty procedures that feature periareolar incisions are especially likely to cause breast feeding difficulties. Surgery may also damage the lactiferous ducts and the nerves in the nipple areola area. Functional breast feeding difficulties arise if the surgeon cut the milk ducts or the major nerves innervating the breast, or if the milk glands were otherwise damaged. Milk duct and nerve damage are more common if the incisions cut tissue near the nipple. The milk glands are most likely to be affected by subglandular implants (under the gland), and by large sized breast implants, which pinch the lactiferous ducts and impede milk flow. Small sized breast implants, and submuscular implantation, cause fewer breast function problems; however, it is impossible to predict whether a woman who undergoes breast augmentation will be able to successfully breast feed since some women are able to breast feed after periareolar incisions and subglandular placement and some are not able to after augmentation using submuscular and other types of surgical incisions. The breast cancer studies Cancer in the Augmented Breast: Diagnosis and Prognosis (1993) and Breast Cancer after Augmentation Mammoplasty (2001) of women with breast implant prostheses reported no significant differences in disease stage at the time of the diagnosis of cancer; prognoses are similar in both groups of women, with augmented patients at a lower risk for subsequent cancer recurrence or death. Conversely, the use of implants for breast reconstruction after breast cancer mastectomy appears to have no negative effect upon the incidence of cancer related death. That patients with breast implants are more often diagnosed with palpable—but not larger—tumors indicates that equal sized tumors might be more readily palpated in augmented patients, which might compensate for the impaired mammogram images. The ready palpability of the breast cancer tumor(s) is consequent to breast tissue thinning by compression, innately in smaller breasts a priori (because they have lesser tissue volumes), and that the implant serves as a radio opaque base against which a cancerous tumor can be differentiated. The breast implant has no clinical bearing upon lumpectomy breast conservation surgery for women who developed breast cancer after the implantation procedure, nor does the breast implant interfere with external beam radiation treatments (XRT); moreover, the post treatment incidence of breast tissue fibrosis is common, and thus a consequent increased rate of capsular contracture. There is tentative evidence that women who have had breast augmentation, have worse breast cancer prognosis. The use of implants for breast reconstruction after breast cancer mastectomy appears to have no negative effect upon cancer related death. There have been multiple reported cases of other adverse effects of mammography of women with breast implants; ruptures resulting from pressure exerted on the breast implant make up a majority of these cases.

Since the late nineteenth century, breast implants have been used to surgically augment the size (volume), modify the shape (contour), and enhance the feel (tact) of a woman's breasts. In 1895, surgeon Vincenz Czerny effected the earliest breast implant emplacement when he used the patient's autologous adipose tissue, harvested from a benign lumbar lipoma, to repair the asymmetry of the breast from which he had removed a tumor. In 1889, surgeon Robert Gersuny experimented with paraffin injections, with disastrous results arising from the breakup of the paraffin into smaller bodies following the procedure.

From the first half of the twentieth century, physicians used other substances as breast implant fillers—ivory, glass balls, ground rubber, ox cartilage, Terylene wool, gutta percha, Dicora, polyethylene chips, Ivalon (polyvinyl alcohol—formaldehyde polymer sponge), a polyethylene sac with Ivalon, polyether foam sponge (Etheron), polyethylene tape (Polystan) strips wound into a ball, polyester (polyurethane foam sponge) Silastic rubber, and teflon silicone prostheses. In the mid twentieth century, Morton I. Berson, in 1945, and Jacques Maliniac, in 1950, each performed flap based breast augmentations by rotating the patient's chest wall tissue into the breast to increase its volume. Furthermore, throughout the 1950s and the 1960s, plastic surgeons used synthetic fillers—including silicone injections received by some 50,000 women, from which developed silicone granulomas and breast hardening that required treatment by mastectomy. In 1961, the American plastic surgeons Thomas Cronin and Frank Gerow, and the Dow Corning Corporation, developed the first silicone breast prosthesis, filled with silicone gel; in due course, the first augmentation mammoplasty was performed in 1962 using the Cronin–Gerow Implant, prosthesis model 1963. In 1964, the French company Laboratoires Arion developed and manufactured the saline breast implant, filled with saline solution, and then introduced for use as a medical device in 1964.

In 1988, twenty six years after the 1962 introduction of breast implants filled with silicone gel, the U. S. Food and Drug Administration (FDA) investigated breast implant failures and the subsequent complications, and re classified breast implant devices as Class III medical devices, and required from manufacturers the documentary data substantiating the safety and efficacy of their breast implant devices. In 1992, the FDA placed silicone gel breast implants in moratorium in the U. S., because there was "inadequate information to demonstrate that breast implants were safe and effective". Nonetheless, medical access to silicone gel breast implant devices continued for clinical studies of post mastectomy breast reconstruction, the correction of congenital deformities, and the replacement of ruptured silicone gel implants. The FDA required from the manufacturers the clinical trial data, and permitted their providing breast implants to the breast augmentation patients for the statistical studies required by the U. S. Food and Drug Administration. In 2000, the FDA approved saline breast implant Premarket Approval Applications (PMA) containing the type and rate data of the local medical complications experienced by the breast surgery patients. "Despite complications experienced by some women, the majority of those women still in the Inamed Corporation and Mentor Corporation studies, after three years, reported being satisfied with their implants." In 2006, for the Inamed Corporation and for the Mentor Corporation, the U. S. Food and Drug Administration lifted its restrictions against using silicone gel breast implants for breast reconstruction and for augmentation mammoplasty. Yet, the approval was conditional upon accepting FDA monitoring, the completion of 10 year mark studies of the women who already had the breast implants, and the completion of a second, 10 year mark study of the safety of the breast implants in 40,000 other women. The FDA warned the public that breast implants do carry medical risks, and recommended that women who undergo breast augmentation should periodically undergo MRI examinations to screen for signs of either shell rupture or of filler leakage, or both conditions; and ordered that breast surgery patients be provided with detailed, informational brochures explaining the medical risks of using silicone gel breast implants. One of the major topics of that public meeting was the evidence that Allergan BIOCELL textured breast implants were the type of breast implants most likely to cause BIA ALCL. Following the committee meeting, the FDA requested that Allergan recall their BIOCELL textured breast implants and tissue expanders, and in July 2019 Allergan took those BIOCELL textured implants and expanders off the market. Allergan subsequently announced they would contact all customers who had purchased their products to ensure they were aware of the recall. The U. S. Food and Drug Administration established the age ranges for women seeking breast implants; for breast reconstruction, silicone gel filled implants and saline filled implants were approved for women of all ages; for breast augmentation, saline implants were approved for women 18 years of age and older; silicone implants were approved for women 22 years of age and older. Because each breast implant device entails different medical risks, the minimum age of the patient for saline breast implants is different from the minimum age of the patient for silicone breast implants—because of the filler leakage and silent shell rupture risks; thus, periodic MRI screening examinations are the recommended post operative, follow up therapy for the patient. In other countries, in Europe and Oceania, the national health ministries' breast implant policies do not endorse periodic MRI screening of asymptomatic patients, but suggest palpation proper—with or without an ultrasonic screening—to be sufficient post operative therapy for most patients.