Editing Breast augmentation (section)

===Capsular contracture===
{{Main|Capsular contracture}}
The human body's [[immune response]] to a surgically installed foreign object{{snd}}breast implant, cardiac [[pacemaker]], [[orthopedic]] [[prosthesis]]{{snd}}is to encapsulate it with [[Scar|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]]{{snd}}which should be distinguished from normal capsular tissue{{snd}}occurs when the collagen-fiber capsule thickens and compresses the breast implant; it is a painful [[Complication (medical)|complication]] that might distort either the breast implant, or the breast, or both.{{cn|date=July 2024}}

[[Image:Capsular fibrosis.jpg|thumb|right|225px|Breast-implant failure: Capsular contracture is a medical complication, in this case, a Baker scale Grade IV contraction, of a subglandular silicone implant in the right breast.]]

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);<ref name="Barnsley2006">{{cite journal | author=Barnsley GP| title= Textured surface Breast Implants in the Prevention of Capsular Contracture among Breast Augmentation Patients: a Meta-analysis of Randomized Controlled Trials | journal=Plastic and Reconstructive Surgery | year=2006 | pages=2182–2190| volume=117 | issue=7 | pmid=16772915| doi= 10.1097/01.prs.0000218184.47372.d5 | first2=LJ | first3=SE | last2=Sigurdson | last3=Barnsley| s2cid= 35420582 }}</ref><ref name="Wong2006">{{cite journal |vauthors=Wong CH, Samuel M, Tan BK, Song C | s2cid= 29643167| title= Capsular Contracture in Subglandular Breast Augmentation with Textured versus Smooth Breast Implants: a Systematic Review| journal=Plastic and Reconstructive Surgery | year=2006 | pages=1224–1236| volume=118 | issue=5 | pmid=17016195| doi= 10.1097/01.prs.0000237013.50283.d2}}</ref><ref name="Handel2006">{{cite journal | author=Handel N| title= Long-term safety and efficacy of polyurethane foam-covered breast implants | journal=Journal of Aesthetic Surgery |date=May 2006 | pages=265–274| volume=26 | issue=3| doi= 10.1016/j.asj.2006.04.001 | pmid=19338905 |name-list-style=vanc | display-authors=1 | last2=Gutierrez | first2=J| doi-access=free }}</ref> 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.<ref name="Mladick1993">{{cite journal | author=Mladick RA| title= "No-touch" submuscular saline breast augmentation technique | journal=Journal of Aesthetic Surgery | year=1993 | pages=183–192| volume=17 | issue=3 | pmid= 8213311| doi= 10.1007/BF00636260 | s2cid= 39767802 }}</ref><ref name="Adams2006">{{cite journal | author=Adams WP jr.| title= Enhancing Patient Outcomes in Aesthetic and Reconstructive Breast Surgery using Triple Antibiotic Breast Irrigation: Six-year Prospective Clinical Study | journal=Plastic and Reconstructive Surgery | year=2006 | pages=30–6 | volume=117 | issue=1 | pmid=16404244 | doi=10.1097/01.prs.0000185671.51993.7e | last2=Rios | first2=Jose L. | last3=Smith | first3=Sharon J. | s2cid= 35238465 }}</ref> The use of a funnel device for implant insertion has also been shown to reduce the rate of capsular contracture.<ref>{{Cite journal|last1=Newman|first1=Ashley N.|last2=Davison|first2=Steven P.|date=June 2018|title=Effect of Keller Funnel on the Rate of Capsular Contracture in Periareolar Breast Augmentation|journal=Plastic and Reconstructive Surgery. Global Open|volume=6|issue=6|pages=e1834|doi=10.1097/GOX.0000000000001834|issn=2169-7574|pmc=6157951|pmid=30276059}}</ref>

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 [[medical ultrasound|ultrasonic]] therapy, [[leukotriene antagonist|leukotriene pathway inhibitors]] such as [[zafirlukast]] (Accolate) or [[montelukast]] (Singulair), and [[Pulsed Electromagnetic Field Therapy|pulsed electromagnetic field therapy]] (PEMFT).<ref name="Planas2001">{{cite journal | author=Planas J| title= Five-year experience on ultrasonic treatment of breast contractures | journal=Aesthetic Plastic Surgery | year=2001| pages=89–93 | volume=25 | issue=2 | pmid=11349308| doi= 10.1007/s002660010102 | first2=V | first3=G | last2=Cervelli | last3=Planas| s2cid= 2784003 }}</ref><ref name="Schlesinger2002">{{cite journal |author1=Schlesinger SL |author2=wt al | title= Zafirlukast (Accolate): A new treatment for capsular contracture | journal=Aesthetic Plast. Surg. | year=2002| pages=329–36| volume=22 | issue=4 | doi=10.1067/maj.2002.126753 | pmid=19331987| doi-access=free }}</ref><ref name="Scuderi">{{cite journal | author=Scuderi N| title= The effects of zafirlukast on capsular contracture: preliminary report| journal=Aesthetic Plast. Surg. | year=2006| pages=513–520 | volume=30 | issue=5 | pmid=16977359| doi= 10.1007/s00266-006-0038-3 |name-list-style=vanc | display-authors=1 | last2=Mazzocchi | first2=Marco | last3=Fioramonti | first3=Paolo | last4=Bistoni | first4=Giovanni| s2cid= 251008}}</ref><ref name="Silver1982">{{cite journal | author=Silver H| title= Reduction of capsular contracture with two-stage augmentation mammaplasty and pulsed electromagnetic energy (Diapulse therapy) | journal=Plastic and Reconstructive Surgery | year=1982| pages=802–805 | volume=69 | issue=5 | pmid=7071225| doi= 10.1097/00006534-198205000-00013| s2cid= 8451166 }}</ref>

====Repair and revision surgeries====
When the woman 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 ([[Medical device|Class III medical device]], in the U.S.), it is likely she might require replacing the breast implants. The common revision surgery indications include major and minor medical complications, capsular contracture, shell rupture, and device deflation.<ref name = FDA_2004b /> Revision incidence rates were greater for breast reconstruction patients, because of the post-mastectomy changes to the soft-tissues and to the skin envelope of the breast, and to the [[human anatomy|anatomical]] borders of the breast, especially in women who received adjuvant external [[radiation therapy]].<ref name = FDA_2004b /> Moreover, besides breast reconstruction, [[breast cancer]] patients usually undergo revision surgery of the nipple-areola complex (NAC), and symmetry procedures upon the opposite breast, to create a bust of natural appearance, size, form, and feel. Carefully matching the type and size of the breast implants to the patient's pectoral soft-tissue characteristics reduces the incidence of revision surgery. Appropriate tissue matching, implant selection, and proper implantation technique, the re-operation rate was 3.0% at the 7-year-mark, compared with the re-operation rate of 20% at the 3-year-mark, as reported by the U.S. Food and Drug Administration.<ref name="Tebbets2006">{{Cite journal | last1 = Tebbetts | first1 = J. B. | title = "Out points" criteria for breast implant removal without replacement and criteria to minimize reoperations following breast augmentation | journal = Plastic and Reconstructive Surgery | volume = 114 | issue = 5 | pages = 1258–1262 | year = 2004 | pmid = 15457046 | doi=10.1097/01.prs.0000136802.91357.cf}}</ref><ref name="Tebbets2">{{Cite journal | last1 = Tebbetts | first1 = J. B. | s2cid = 27630646 | title = Achieving a Zero Percent Reoperation Rate at 3 Years in a 50-Consecutive-Case Augmentation Mammaplasty Premarket Approval Study | doi = 10.1097/01.prs.0000239602.99867.07 | journal = Plastic and Reconstructive Surgery | volume = 118 | issue = 6 | pages = 1453–1457 | year = 2006 | pmid = 17051118 }}</ref>

====Systemic disease and sickness====
Since the 1990s, reviews of the studies that sought causal links between silicone-gel breast implants and [[systemic disease]] reported no link between the implants and subsequent systemic and autoimmune diseases.<ref name=Canada_2005>{{cite web|title=Expert Advisory Panel on Breast Implants: Record of Proceedings|publisher=HealthCanada|url=http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/sci-consult/implant-breast-mammaire/eapbi_rop_gceim_crd_2005-09-29_e.html|date=2005-09-29|access-date=2007-05-04|archive-url=https://web.archive.org/web/20071107040623/http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/sci-consult/implant-breast-mammaire/eapbi_rop_gceim_crd_2005-09-29_e.html|archive-date=2007-11-07}}</ref><ref name=BIIB_2001>{{cite book|author=Therapeutic Goods Administration|title=Breast Implant Information Booklet|edition=4th|publisher=Australian Government|year=2001|url=http://www.tga.gov.au/docs/pdf/breasti4.pdf|isbn=978-0-642-73579-9|access-date=2011-03-18|archive-url=https://web.archive.org/web/20070101081442/http://www.tga.gov.au/docs/pdf/breasti4.pdf|archive-date=2007-01-01|url-status=dead}}</ref><ref name=EQUAM_2000>{{cite web|author=European Committee on Quality Assurance and Medical Devices in Plastic Surgery | title=Consensus Declaration on Breast Implants|url=http://www.secpre.org/pdf/equam.pdf|date=2000-06-23|access-date=2007-05-04 |archive-url = https://web.archive.org/web/20061230061944/http://www.secpre.org/pdf/equam.pdf |archive-date = December 30, 2006}}</ref><ref name=UK_1998>{{cite web|title=Silicone Gel Breast Implant Report Launched - No Epidemiological Evidence For Link With Connective Tissue Disease - Independent Review Group|url=http://www.dh.gov.uk/en/Publicationsandstatistics/Pressreleases/DH_4024791|date=1998-07-13|access-date=2007-05-04}}</ref> Nonetheless, during the 1990s, thousands of women claimed sicknesses they believed were caused by their breast implants, including [[neurology|neurological]] and [[rheumatology|rheumatological]] health problems.
[[Image:BreastImplant09.JPG|thumb|right|225px|Breast Implant: the chest X-ray of a woman with bilaterally emplaced breast implants shows that the prostheses are radiographically opaque, and are foreign objects in her body, but not of her body.]]
In the study ''Long-term Health Status of Danish Women with Silicone Breast Implants'' (2004), the national healthcare system of Denmark reported that women with implants did not risk a greater incidence and diagnosis of [[autoimmune disease]], when compared to same-age women in the general population; that the incidence of musculoskeletal disease was lower among women with breast implants than among women who had undergone other types of cosmetic surgery; and that they had a lower incidence rate than like women in the general population.<ref name="Breiting2004">{{cite journal|vauthors=Breiting VB, Holmich LR, Brandt B, Fryzek JP, Wolthers MS, Kjoller K, McLaughlin JK, Wiik A, Friis S |title=Long-term Health Status of Danish Women with Silicone Breast Implants|journal=Plastic and Reconstructive Surgery |year=2004|pages=217–226 |volume=114|pmid=15220596|doi=10.1097/01.PRS.0000128823.77637.8A|issue=1|s2cid=20584928}}</ref><ref name="Kjoller2004">{{cite journal |vauthors=Kjoller K, Holmich LR, Fryzek JP, Jacobsen PH, Friis S, McLaughlin JK, Lipworth L, Henriksen TF, Hoier-Madsen M, Wiik A, Olsen JH |title=Self-reported musculoskeletal symptoms among Danish women with cosmetic breast implants|journal= Annals of Plastic Surgery|year=2004|pages=1–7|volume=52 | pmid= 14676691|doi=10.1097/01.sap.0000101930.75241.55 | issue=1|s2cid=33639882}}</ref>

Follow-up [[Longitudinal study|longitudinal studies]] of these breast implant patients confirmed the previous findings on the matter.<ref name="Fryzek2007">{{cite journal|vauthors=Fryzek JP, Holmich L, McLaughlin JK, Lipworth L, Tarone RE, Henriksen T, Kjoller K, Friis S |title=A Nationwide Study of Connective Tissue Disease and Other Rheumatic Conditions Among Danish Women With Long-Term Cosmetic Breast Implantation|journal=Annals of Epidemiology |year=2007|pmid=17321754|doi=10.1016/j.annepidem.2006.11.001|volume=17|pages=374–379|issue=5}}</ref> European and North American studies reported that women who underwent augmentation mammoplasty, and any plastic surgery procedure, tended to be healthier and wealthier than the general population, before and after implantation; that plastic surgery patients had a lower [[standardized mortality ratio]] than did patients for other surgeries; yet faced an increased risk of death by [[lung cancer]] than other plastic surgery patients. Moreover, because only one study, the Swedish ''Long-term Cancer Risk Among Swedish Women with Cosmetic Breast Implants: an Update of a Nationwide Study'' (2006), controlled for [[tobacco smoking]] information, the data were insufficient to establish verifiable statistical differences between smokers and non-smokers that might contribute to the higher [[lung cancer]] mortality rate of women with breast implants.<ref>{{cite journal|vauthors=Brinton LA, Lubin JH, Murray MC, Colton T, Hoover RN |title=Mortality Rates Among Augmentation Mammoplasty patients: an update|journal=Epidemiology|year=2006|pages=162–9|volume=17|issue=2|pmid=16477256|doi=10.1097/01.ede.0000197056.84629.19|s2cid=22285852|doi-access=free}}</ref><ref>{{cite journal|vauthors=McLaughlin JK, Lipworth L, Fryzek JP, Ye W, Tarone RE, Nyren O |title=Long-term Cancer Risk Among Swedish Women with Cosmetic Breast Implants: an Update of a Nationwide Study| journal=J Natl Cancer Inst|year=2006|pages=557–60|volume=98|issue=8|pmid=16622125|doi=10.1093/jnci/djj134|doi-access=free}}</ref> The long-term study of 25,000 women, ''Mortality among Canadian Women with Cosmetic Breast Implants'' (2006), reported that the "findings suggest that breast implants do not directly increase mortality in women."<ref name="Villenueve2006">{{cite journal|author=Villenueve PJ|title=Mortality among Canadian Women with Cosmetic Breast Implants|journal=American Journal of Epidemiology|date=June 2006|pmid=16777929|doi=10.1093/aje/kwj214|volume=164|pages=334–341|issue=4|name-list-style=vanc|display-authors=1|last2=Holowaty|first2=EJ|last3=Brisson|first3=J|last4=Xie|first4=L|last5=Ugnat|first5=AM|last6=Latulippe|first6=L|last7=Mao|first7=Y |doi-access=free}}</ref>

The study ''Silicone gel Breast Implant Rupture, Extracapsular Silicone, and Health Status in a Population of Women'' (2001), reported increased incidences of [[fibromyalgia]] among women who had [[Capsular contracture|extracapsular silicone-gel leakage]] than among women whose breast implants neither ruptured nor leaked.<ref name="Brown2001">{{cite journal|vauthors=Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS |title=Silicone gel Breast Implant Rupture, Extracapsular Silicone, and Health Status in a Population of Women|journal=Journal of Rheumatology|year=2001|pages=996–1003|volume=28|issue=5|pmid=11361228 |url=https://www.fda.gov/cdrh/breastimplants/extracapstudy.html |archive-url=https://web.archive.org/web/20010605000700/http://www.fda.gov/cdrh/breastimplants/extracapstudy.html |url-status=dead |archive-date=June 5, 2001 }}</ref> The study later was criticized as significantly methodologically flawed, and a number of large subsequent follow-up studies have not shown any evidence of a causal device–disease association. After investigating, the U.S. FDA has concluded "the weight of the [[Epidemiology|epidemiological]] evidence published in the literature does not support an association between fibromyalgia and breast implants."<ref>{{cite journal|vauthors=Lipworth L, Tarone RE, McLaughlin JK |title=Breast Implants and Fibromyalgia: a Review of the Epidemiologic Evidence|journal=Annals of Plastic Surgery|year=2004|pages=284–287|volume=52|issue=3|pmid=15156983|doi=10.1097/01.sap.0000116024.18713.28|s2cid=19370286}}</ref><ref name=FDA_2004>{{cite web|title=Diseases|work=FDA Breast Implant Consumer Handbook - 2004|url=https://www.fda.gov/cdrh/breastimplants/handbook2004/diseases.html|date=2004-06-08|access-date=2007-05-04|archive-url=https://web.archive.org/web/20070609134559/https://www.fda.gov/cdrh/breastimplants/handbook2004/diseases.html|archive-date=2007-06-09}}</ref> The systemic review study, ''Silicone Breast implants and Connective tissue Disease: No Association'' (2011) reported the investigational conclusion that "any claims that remain regarding an association between cosmetic breast implants and CTDs are not supported by the scientific literature".<ref>{{cite journal|vauthors=Lipworth L, Holmich LR, McLaughlin JK |title=Silicone Breast implants and Connective tissue Disease: No Association|journal=Semin Immunopathol|year=2011|pages=287–294|volume=33|issue=3|pmid=21369953|doi=10.1007/s00281-010-0238-4|s2cid=22297654}}</ref>