Breast implant

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 and polyurethane foam-covered implants is a type of lymphoma known as breast implant-associated anaplastic large-cell lymphoma.
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 hydrogel, 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.

Uses

A mammoplasty procedure for the placement of breast implant devices has three purposes:

primary reconstruction: the replacement of breast tissues damaged by trauma, disease, and failed anatomic development.
revision and reconstruction: to revise the outcome of a previous breast reconstruction surgery.
primary augmentation: to aesthetically augment the size, form, and feel of the breasts.

The operating room time of post–mastectomy breast reconstruction, and of breast augmentation surgery is determined by the procedure employed, the type of incisions, the breast implant, and the pectoral locale of the implant pocket.
Recent research has indicated that mammograms should not be done with any greater frequency than that used in normal procedure in patients undergoing breast surgery, including breast implant, augmentation, mastopexy, and breast reduction.

Psychology

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 about the aesthetics of her person. The studies Body Image Concerns of Breast Augmentation Patients and Body Dysmorphic Disorder and Cosmetic Surgery 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, 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, 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.

Complications

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, late hematoma, seroma, incision-site breakdown. 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 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 at the 10-year mark.

Safety

In the 1990s, several reports reviewed the few studies evaluating any increased risk of systemic and auto-immune diseases among women with breast implants. The conclusion at that time was that there was no evidence establishing a causal connection between the implantation of silicone breast implants and either type of disease. However, the Institute of Medicine report pointed out that these earlier studies included too few women to conclusively evaluate the impact on these rare diseases. In addition, many of the studies included women who had breast implants for just a few months, which would be too early to develop a diagnosed autoimmune disease. In recent years, large epidemiological studies have reported clinically and statistically significant increases in some of these diseases. A study by Watad and colleagues that was published in 2018 compared and examined the medical records of more than 24,000 women with breast implants to more than 98,000 "matched controls" who did not have breast implants but shared very similar demographic traits. The study found a statistically significant 22% overall increase in diagnosed autoimmune or rheumatic disorders. The greatest increases in diagnoses for women with breast implants was for Sjögren's syndrome, Multiple Sclerosis, and sarcoidosis, each of which were 58%-98% higher in women with breast implants. That analysis was based on Israeli women with breast implants as confirmed by medical records, and the analyses of diseases were based on diagnoses made after the women got breast implants that were included in medical records during up to 20 years of follow-up.
A published study of U.S. women with similar results was published in 2019 by Coroneos and his colleagues at MD Anderson Medical Center. The data were based on two studies with a combined total of almost 100,000 women with breast implants, but many dropped out of the study within a few years of their breast implant surgery. However, of the women in the study for at least two years, the researchers reported an 800% increase in Sjögren syndrome, 700% increase in scleroderma, and almost 600% increase in rheumatoid arthritis among women with breast implants compared to the general population of women of the same age and demographics.
Recent research on women who reported autoimmune and other system symptoms but were not diagnosed with an autoimmune disease evaluated whether the women's symptoms changed after their implants were removed. A 2020 study on the effectiveness of explant surgery on women with breast implant illness found that nearly all of 750 women who underwent explant surgery reported a significant improvement in their health within a month after their surgery. Researchers focused on the following symptoms: hair loss, memory loss, dry eyes and/or blurred vision, numbness or tingling in the extremities, chronic fatigue, joint pain, rashes, breast pain, food intolerance, flu-like symptoms, and difficulty breathing. The same authors also published a study on the impact of breast implant removal on breathing difficulties and found a statistically significant improvement in well-established objective measures of pulmonary function following explant surgery.

Year	Country	Systemic Review Group	Conclusions
1991–93	United Kingdom	Independent Expert Advisory Group	There was no evidence of an increased risk of connective-tissue disease in patients who had undergone silicone-gel breast implant emplacement, and no cause for changing either breast implant practice or policy in the U.K.
1996	United States	U.S. Institute of Medicine	There was "insufficient evidence for an association of silicone gel- or saline-filled breast implants with defined connective tissue disease."
1996	France	Agence Nationale pour le Developpement de l'Evaluation Medicale	French original: "Nous n'avons pas observé de connectivité 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...." English translation: "We did not observe connective tissue diseases to be directly or indirectly associated by the presence of a breast implant, in particular one of silicone gel...."
1997	Australia	Therapeutic Devices Evaluation Committee	The "current, high-quality literature suggest that there is no association between breast implants and connective tissue disease-like syndromes."
1998	Germany	Federal Institute for Medicine and Medical Products	Reported 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."
2000	United States	Federal court-ordered review	"No evidence of an association between... silicone-gel-filled breast implants specifically, and any of the individual CTDs, all definite CTDs combined, or other auto-immune or rheumatic conditions."
2000	European Union	European Committee on Quality Assurance & Medical Devices in Plastic Surgery	"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 evidence that silicone allergy, silicone intoxication, atypical disease or a 'new silicone disease' exists."
2001	United Kingdom	UK Independent Review Group	"There is no evidence of an association with an abnormal immune response or typical or atypical connective tissue diseases or syndromes."
2001	United States	Court-appointed National Science Panel review	The panel evaluated established and undifferentiated connective tissue diseases, and concluded there was no causal evidence between breast implants and these CTDs.
2003	Spain	Science and Technology Options Assessment	The STOA report to the European Parliament Petitions Committee reported that the current scientific evidence demonstrates no solid, causal evidence linking SBI to severe diseases, e.g. breast cancer, connective tissue diseases.
2009	European Union	International Committee for Quality Assurance, Medical Technologies & Devices in Plastic Surgery panel	The consensus statement of the Transatlantic Innovations conference indicated that additional medical studies demonstrated no association between silicone gel-filled breast implants and carcinoma, or any metabolic, immune, or allergic disorder.