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Complications After Breast Augmentation
Breast augmentation is one of the most commonly performed plastic surgery procedures. It is important for primary care providers who perform clinical breast exams to be well versed in complications that can occur after the immediate postsurgical period and to prepare patients with augmented breasts for the likelihood of requiring a secondary procedure at some time.
Breast augmentation continues to rank as the procedure most commonly performed by US plastic surgeons. According to data from the American Society of Plastic Surgeons,1 307,000 breast augmentation procedures were performed in the US in 2011—a 4% increase from the previous year. Breast implants are not permanent devices, and most patients can expect to undergo a secondary procedure during their lifetime.2
Hematomas and infections associated with breast augmentation usually occur within two to 14 days following surgery, while the patient is still under the care of the plastic surgeon.2,3 For long-term complications, however, patients are likely to consult their primary care or gynecologic provider. Thus, it is important that any clinician who performs clinical breast exams be well versed in the complications, both local and systemic, that can occur after the immediate postsurgical period in patients who have undergone breast augmentation.
Common Complications of Breast Enhancement
Complications after breast augmentation are not uncommon. They can occur in women with either silicone gel– or saline-filled implants; conflicting incidence rates for capsular contracture (the most common local complication3,4) have been reported following insertion of silicone gel–filled implants, compared with saline implants.5,6 It has been noted, however, that prospective data comparing the two implant types are lacking in the literature.7
Complications can be categorized as either local or systemic. In addition to capsular contracture, local complications (which are more common) include implant rupture or deflation, and implant rippling or wrinkling.
Systemic complications may include anaplastic large-cell lymphoma, a rare but serious complication that is currently under study for its potential association with breast implants8 (see third article in this series, “Anaplastic Large-Cell Lymphoma”9-14). Other systemic sequelae include autoimmune disorders, connective tissue disease, and fibrositis/fibromyalgia conditions; these conditions can only be addressed in an article of greater scope.
In 2006, breast implant manufacturers were mandated to conduct postapproval studies regarding the devices’ safety15 (see fourth article in this series, “History of Breast Implant Regulation,”2,15-20). Findings from these studies can facilitate primary care providers’ management of patients who have augmented breasts.
Capsular Contracture
Capsular contracture occurs with frequencies ranging from 1.9% to 2.3%.8 As a result of the immune response to any foreign body, collagen fibers form and weave around the prosthetic device once it is implanted. For reasons not completely understood, these fibers can begin to tighten over time. As the capsule continues to tighten and harden, the implant is then compressed, resulting in breast pain and deformity.
The degree of capsular contracture is categorized according to Baker’s classification system regarding implant position and breast firmness postaugmentation.2,21 A Baker’s grade I designation implies that the modified breast is soft and looks normal. Grade II describes a breast that is slightly firm upon exam but looks completely normal. In grade III, the breast is firm and has taken on an abnormal appearance. In grade IV, the breast looks abnormal and is firm on examination, with the patient describing significant pain.
Some researchers believe that capsular contracture develops because of a subclinical bacterial infection, while others suggest that silicone leakage may be the cause.6,22,23 A patient who is diagnosed with a hematoma during the postoperative period is at increased risk for capsular contracture, and one who has been treated previously for capsular contracture has a significant risk for recurrence.2,24
Capsular contracture is usually treated surgically by a capsulectomy or a capsulotomy. Currently, the preferred procedure is an open capsulectomy to remove the implant, surgically excise the entire capsule, and replace the implant.4
Implant Deflation, Rupture
Most ruptures of implants (whether they are used cosmetically or for reconstruction) occur between 10 and 15 years after implantation.3,25 Incidence of implant removal by 10 years postsurgery ranges from 21% to 32% for silicone gel–filled implants, depending on the specific implant model.17
Saline implant deflation is relatively easy to detect because it presents with a rapid decrease in breast size on the affected side. Ruptures of silicone gel–filled implants, by contrast, can go undetected for years—hence the term silent rupture applied in this circumstance.3 If a rupture is detected, the faulty breast implant is removed and returned to the manufacturer for investigation.
If surgical instrumentation leads to a puncture during saline gel–filled implant surgery, it is usually noticed immediately. A silicone gel–filled implant can also be punctured during the implantation procedure, often with no obvious signs of the rupture.
Rupture of a silicone gel–filled implant may be intracapsular or extracapsular. In intracapsular ruptures, the contents of the implant remain within the capsule that has formed around the implant. Extracapsular ruptures involve migration of the silicone material outside the capsule.3 Current-generation silicone implants are increasingly biodurable, thereby reducing the risk for silicone migration.26,27
MRI is currently considered the study of choice to detect silent rupture of a silicone gel–filled implant.28 As primary care providers should be aware, the FDA recommends that women with silicone gel–filled implants undergo MRI screening three years after implantation and every two years thereafter to assess the implants’ integrity.17 This applies to all age-groups and does not replace screening mammography requirements for breast cancer.
While mammography is ideal for detecting extracapsular silicone implant ruptures, it fails to detect intracapsular implant rupture consistently.29 Breast ultrasound cannot effectively detect ruptures in the posterior portion of the implant and cannot evaluate the chest wall. Thus, MRI, with its high spatial resolution and marked contrast between implants and natural breast tissue, is considered most effective in detecting either intracapsular or extracapsular ruptures.3,28,29
Despite earlier reports that implant rupture could prompt an immunologic reaction, giving rise to autoimmune or related diseases, subsequent studies reveal “no association between silicone gel–filled breast implants and connective tissue disease, breast cancer, or reproductive problems.”17 Apart from a relatively low risk for silicone migration, implant rupture has been deemed relatively harmless.30
Implant Wrinkling, Folding
Implant wrinkling visible to the naked eye can mar the aesthetic appearance of an augmented breast. In some cases, the wrinkled implant may be detected only by palpation. Causes of wrinkling include:
• Thin skin and insufficient natural breast tissue, especially in the lower outer pole
• Subglandular placement of the implant, which allows less coverage over the implant than submuscular placement; and
• Use of saline-filled or textured-surface implants.
Because saline has a lower viscosity than silicone, it may allow lower-pole expansion and settling—and hence, wrinkling. Insufficient filling in saline implants may contribute to the problem, in addition to palpable shell folding, palpable shifts of filler material, sloshing, and other compromised aesthetic results.3,31
In rare cases, wrinkling over thin skin can cause implant extrusion. Additionally, the friction created as the shell rubs against itself can cause implant deflation or even rupture due to the development of a “hot spot.”
Options to address implant wrinkling are to replace saline-filled implants with silicone gel–filled implants or to revise placement of the implant from the subglandular to the submuscular location. Use of acellular dermal matrix can help reinforce existing breast tissue, especially when placed in the lower pole of the affected breast.32,33
Anaplastic Large-Cell Lymphoma
Of rising concern is a possible association between certain breast implants (ie, textured vs nontextured implants; silicone vs saline implants) and anaplastic large-cell lymphoma (ALCL).9-13 RAND Health14 sponsored a study conducted by 10 multidisciplinary experts, who agreed on the following points:
(1) A positive association exists between breast implants and ALCL, with the actual number of cases probably underrecognized.
(2) Any recurrent, clinically evident seroma developing longer than six months after breast implantation should be aspirated for cytologic analysis.
(3) Anaplastic lymphoma kinase (ALK)–negative ALCL that develops in the vicinity of breast implants is distinct from systemic ALK-negative ALCL, is clinically indolent disease, and has a favorable prognosis.
(4) Management of ALCL requires removal of the involved implant and capsule (a strategy that is likely to prevent recurrence) and evaluation for the disease at other sites.
(5) Adjuvant radiation or chemotherapy need not be offered to women with capsule-confined disease.13,14
Currently, the FDA has called for further research, concluding, “it is not possible to confirm with statistical certainty that breast implants cause ALCL.”11
Because occurrence of ALCL is rare, the absolute risk for the disease may be extremely low. However, primary care providers who detect a seroma or note increased size in one augmented breast over another six months or longer after an augmentation procedure are advised to refer the patient to a plastic surgeon or other appropriate specialist.11
All cases of confirmed ALCL in women with breast implants should be reported to [email protected]. This is a registry begun by the FDA, in conjunction with the Plastic Surgery Foundation and the American Society of Plastic Surgeons, to gather data about ALCL in women with breast implants.
History of Breast Implant Regulation
Silicone gel–filled implants, introduced in the US in 1962, were classified as moderate-risk (Class II) medical devices when Congress passed the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act.17 In the 1980s, concerns regarding the safety of breast implants led to extensive studies. Data from the FDA’s surveillance systems and published case reports led the FDA to upgrade silicone breast implants to a Class III device (presenting “a potential unreasonable risk of illness or injury”), which requires premarket approval.16
In 1992, the FDA removed silicone breast implants from the market for primary augmentation purposes due to persistent concerns about patient safety. From 1992 to 2006, silicone breast implants remained available only for breast reconstruction after mastectomy, correction of congenital deformities, or replacement of existing implants.17 Women who agreed to undergo breast augmentation with silicone gel–filled implants were enrolled in safety studies conducted by the implant manufacturers. Saline implants remained on the market with no limitations on use, but additional studies on these implants were also ordered.
In 1999, the Institute of Medicine (IOM) released a report, “Safety of Silicone Breast Implants,”18 which more clearly delineated the complications associated with silicone gel–filled implant use. The authors concluded that local complications, including implant rupture and capsular contracture, were the primary associated safety issues. Furthermore, the authors of the IOM report found no causal relationship between silicone gel–filled implants and systemic diseases, such as autoimmune disorders or cancer.2,18
In 2006, the FDA restored approval of silicone gel–filled implants, based largely on core studies conducted by the implant manufacturers.15,19,20 “Despite frequent local complications and adverse outcomes,” it was noted, “the FDA determined that the benefits and risks of breast implants were sufficiently understood for women to make informed decisions about their use.”17 The FDA required the manufacturers to continue with several postapproval studies.15
The complications and adverse outcomes most frequently observed in these studies were capsular contracture, reoperation, removal of implant, and implant rupture.17 Revision and reconstruction surgeries typically have higher complication rates than do primary augmentation surgeries.2
Less Common Complications
In synmastia, a rare but serious complication, the breasts become conjoined because the natural intermammary sulcus (the cleft between the breasts) is obliterated. Causative and contributing factors include aggressive medical resection of the breast, medial migration of either or both implants, selection of a breast implant that is too large for the chest wall, a history of multiple breast surgeries, and a chest wall deformity called pectus excavatum.34 Treatment for synmastia is generally surgical. The main goals of surgical treatment are restoration of the initial presternal subcutaneous integrity and medial closure of the pocket.34,35
Bottoming outsimply means descent of the breast implant on the chest wall sufficient to compromise the inframammary fold. Early bottoming out is most likely due to overdissection or insufficient dissection of the implant pocket, whereas later occurrence is generally attributed to the weight of the implant, compromised breast tissue, or poor skin quality. Surgical revision is needed to elevate and reinforce the inframammary fold. As in the case of implant wrinkling, acellular dermal matrix can be added to bolster breast tissue and prevent tissue thinning (and reduce the risk for implant extrusion).32,33
Mondor’s cordsare firm, cord-like bands caused by superficial thrombophlebitis that can involve the lateral thoracic vein, thoracoepigastric vein, or superior epigastric vein.36,37 This condition presents with abrupt-onset pain in the breast or chest wall, preceded by the appearance of a firm, tender cord. Mondor’s cords usually resolve spontaneously but may be treated with warm compresses, NSAIDs, and use of a supportive bra.37
Conclusion
Breast implants are among the most thoroughly studied medical devices. Although systemic complications are sensationalized in the media, local complications are much more prevalent. The primary care provider is often the first clinician to identify complications of breast augmentation, especially beyond the one-year postprocedure period. Thus, primary care providers must be aware of the local complications that may arise.
Anaplastic large-cell lymphoma is being studied as a possible complication of breast augmentation. Clinicians should be alert to possible development of a seroma six months or longer after an augmentation procedure.
References
1.
13.8 million cosmetic plastic surgery procedures performed in 2011 [press release]. Arlington Heights, IL: American Society of Plastic Surgeons; February 9, 2012.
2. FDA. Medical devices: risks of breast implants (2013). www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/Breastimplants/ucm064106.htm. Accessed May 14, 2013.
3. Juanpere S, Perez E, Huc O, et al. Imaging of breast implants: a pictorial review. Insights Imaging. 2011;2:653-690.
4. Adams WP Jr. Capsular contracture: what is it? What causes it? How can it be prevented and managed? Clin Plast Surg. 2009;36:119-126.
5. El-Sheikh Y, Tutino R, Knight C, et al. Incidence of capsular contracture in silicone versus saline cosmetic augmentation mammoplasty: a meta-analysis. Can J Plast Surg. 2008;16:211-215.
6. Blount AL, Martin MD, Lineberry KD, et al. Capsular contracture rate in a low-risk population after primary augmentation mammaplasty. Aesthet Surg J. 2013;33:516-521.
7. Schaub TA, Ahmad J, Rohrich RJ. Capsular contracture with breast implants in the cosmetic patient: saline versus silicone—a systematic review of the literature. Plast Reconstr Surg. 2010;126:2140-2149.
8. Hvilsom GB, Hölmich LR, Henriksen TF, et al. Local complications after cosmetic breast augmentation: results from the Danish Registry for Plastic Surgery of the Breast. Plast Reconstr Surg. 2009;124:919-925.
9. Thompson PA, Lade S, Webster H, et al. Effusion-associated anaplastic large cell lymphoma of the breast: time for it to be defined as a distinct clinico-pathological entity. Haematologica. 2010;95:1977-1979.
10. Brody GS, Deapen D, Gill P, et al. T-cell non-Hodgkin’s anaplastic lymphoma associated with one style of breast implants. Presented at: American Society of Plastic Surgeons Annual Conference; March 20-23, 2010; San Antonio, Texas. Abstract 42.
11. FDA, Center for Devices and Radiological Health. Anaplastic large cell lymphoma (ALCL) in women with breast implants: preliminary FDA findings and analyses (2011). www.fda.gov/MedicalDevices/ProductsandMedical Procedures/ImplantsandProsthetics/BreastImplants/ucm239996.htm. Accessed May 14, 2013.
12. Carty MJ, Pribaz JJ, Antin JH, et al. A patient death attributable to implant-related primary anaplastic large cell lymphoma of the breast. Plast Reconstr Surg. 2011;128:112e-118e.
13. Kim B, Roth C, Young VL, et al. Anaplastic large cell lymphoma and breast implants: results from a structured expert consultation process. Plast Reconstr Surg. 2011;128:629-639.
14. Kim B, Roth CP, Chung KC, et al. Are breast implants linked to a rare form of lymphoma? www.rand.org/pubs/research_briefs/RB9584.html. Accessed May 14, 2013.
15. Silicone gel-filled breast implants approved. FDA Consum. 2007;41:8-9.
16. Johnson JA; Congressional Research Service. FDA regulation of medical devices (2012). www.fas.org/sgp/crs/misc/R42130.pdf. Accessed May 14, 2013.
17. FDA. Update on the safety of silicone gel–filled breast implants (2011). www.fda.gov/downloads/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/UCM260090.pdf. Accessed May 14, 2013.
18. Bondurant S, Ernster V, Herdman R, eds; Committee on the Safety of Silicone Breast Implants, Division of Health Promotion and Disease Prevention, Institute of Medicine. Washington, DC: National Academy Press; 1999.
19. Spear SL, Hedén P. Allergan’s silicone gel breast implants. Expert Rev Med Devices. 2007;4:699-708.
20. Cunningham B. The Mentor core study on silicone MemoryGel breast implants. Plast Reconstr Surg. 2007;120(7 suppl 1):19S-32S.
21. Spear SL, Baker JL Jr. Classification of capsular contracture after prosthetic breast reconstruction. Plast Reconstr Surg. 1995;96:1119-1123.
22. Schreml S, Heine N, Eisenmann-Klein M, Pranti L. Bacterial colonization is of major relevance for high-grade capsular contracture after augmentation mammaplasty. Ann Plast Surg. 2007;59:126-130.
23. Siggelkow W, Faridi A, Spiritus K, et al. Histological analysis of silicone breast implant capsules and correlation with capsular contracture. Biomaterials. 2003;24:1101-1109.
24. Henriksen TF, Fryzek JP, Hölmich LR, et al. Surgical intervention and capsular contracture after breast augmentation: a prospective study of risk factors. Ann Plast Surg. 2005;54:343-351.
25. Amano Y, Aoki R, Kumita S, Kumazaki T. Silicone-selective multishot echo-planar imaging for rapid MRI survey of breast implants. Eur Radiol. 2007;17:1875-1878.
26. Maxwell GP, Van Natta BW, Murphy DK, et al. Natrelle style 410 form-stable silicone breast implants: core study results at 6 years. Aesthet Surg J. 2012;32:709-717.
27. Stevens WG, Harrington J, Alizadeh K, et al. Five-year follow-up data from the US clinical trial for Sientra’s U.S. Food and Drug Administration-approved Silimed® brand round and shaped implants with high-strength silicone gel. Plast Reconstr Surg. 2012;130:973-981.
28. Hold PM, Alam S, Pilbrow WJ, et al. How should we investigate breast implant rupture? Breast J. 2012;18:253-256.
29. Everson LI, Parantainen H, Detlie T, et al. Diagnosis of breast implant rupture: imaging findings and relative efficacies of imaging techniques. AJR Am J Roentgenol. 1994;163:57-60.
30. Hölmich LR, Vejborg IM, Conrad C, et al. Untreated silicone breast implant rupture. Plast Reconstr Surg. 2004;114:204-214.
31. Dowden RV, Reisman NR. Breast implant overfill, optimal fill, and the standard of care. Plast Reconstr Surg. 1999;104:1185-1186.
32. Spear SL, Sinkin JC, Al-Attar A. Porcine acellular dermal matrix (Strattice™) in primary and revision cosmetic breast surgery. Plast Reconstr Surg. 2013;131:1140-1148.
33. Shestak KC. Acellular dermal matrix inlays to correct significant implant malposition in patients with compromised local tissues. Aesthet Surg J. 2011;31(7 suppl):85S-94S.
34. Spear SL, Bogue DP, Thomassen JM. Synmastia after breast augmentation. Plast Reconstr Surg. 2006;118(7 suppl):168S-171S.
35. Selvaggi G, Giordano S, Ishak L. Synmastia: prevention and correction. Ann Plast Surg. 2010;65:455-461.
36. Coscia J, Lance S, Wong M, Garcia J. Mondor’s thrombophlebitis 13 years after breast augmentation. Ann Plast Surg. 2012;68:336-337.
37. Dudrap E, Milliez PY, Auquit-Auckbur I, Bony-Rerolle S. Mondor’s disease and breast plastic surgery [in French]. Ann Chir Plast Esthet. 2010; 55:233-237.
Breast augmentation is one of the most commonly performed plastic surgery procedures. It is important for primary care providers who perform clinical breast exams to be well versed in complications that can occur after the immediate postsurgical period and to prepare patients with augmented breasts for the likelihood of requiring a secondary procedure at some time.
Breast augmentation continues to rank as the procedure most commonly performed by US plastic surgeons. According to data from the American Society of Plastic Surgeons,1 307,000 breast augmentation procedures were performed in the US in 2011—a 4% increase from the previous year. Breast implants are not permanent devices, and most patients can expect to undergo a secondary procedure during their lifetime.2
Hematomas and infections associated with breast augmentation usually occur within two to 14 days following surgery, while the patient is still under the care of the plastic surgeon.2,3 For long-term complications, however, patients are likely to consult their primary care or gynecologic provider. Thus, it is important that any clinician who performs clinical breast exams be well versed in the complications, both local and systemic, that can occur after the immediate postsurgical period in patients who have undergone breast augmentation.
Common Complications of Breast Enhancement
Complications after breast augmentation are not uncommon. They can occur in women with either silicone gel– or saline-filled implants; conflicting incidence rates for capsular contracture (the most common local complication3,4) have been reported following insertion of silicone gel–filled implants, compared with saline implants.5,6 It has been noted, however, that prospective data comparing the two implant types are lacking in the literature.7
Complications can be categorized as either local or systemic. In addition to capsular contracture, local complications (which are more common) include implant rupture or deflation, and implant rippling or wrinkling.
Systemic complications may include anaplastic large-cell lymphoma, a rare but serious complication that is currently under study for its potential association with breast implants8 (see third article in this series, “Anaplastic Large-Cell Lymphoma”9-14). Other systemic sequelae include autoimmune disorders, connective tissue disease, and fibrositis/fibromyalgia conditions; these conditions can only be addressed in an article of greater scope.
In 2006, breast implant manufacturers were mandated to conduct postapproval studies regarding the devices’ safety15 (see fourth article in this series, “History of Breast Implant Regulation,”2,15-20). Findings from these studies can facilitate primary care providers’ management of patients who have augmented breasts.
Capsular Contracture
Capsular contracture occurs with frequencies ranging from 1.9% to 2.3%.8 As a result of the immune response to any foreign body, collagen fibers form and weave around the prosthetic device once it is implanted. For reasons not completely understood, these fibers can begin to tighten over time. As the capsule continues to tighten and harden, the implant is then compressed, resulting in breast pain and deformity.
The degree of capsular contracture is categorized according to Baker’s classification system regarding implant position and breast firmness postaugmentation.2,21 A Baker’s grade I designation implies that the modified breast is soft and looks normal. Grade II describes a breast that is slightly firm upon exam but looks completely normal. In grade III, the breast is firm and has taken on an abnormal appearance. In grade IV, the breast looks abnormal and is firm on examination, with the patient describing significant pain.
Some researchers believe that capsular contracture develops because of a subclinical bacterial infection, while others suggest that silicone leakage may be the cause.6,22,23 A patient who is diagnosed with a hematoma during the postoperative period is at increased risk for capsular contracture, and one who has been treated previously for capsular contracture has a significant risk for recurrence.2,24
Capsular contracture is usually treated surgically by a capsulectomy or a capsulotomy. Currently, the preferred procedure is an open capsulectomy to remove the implant, surgically excise the entire capsule, and replace the implant.4
Implant Deflation, Rupture
Most ruptures of implants (whether they are used cosmetically or for reconstruction) occur between 10 and 15 years after implantation.3,25 Incidence of implant removal by 10 years postsurgery ranges from 21% to 32% for silicone gel–filled implants, depending on the specific implant model.17
Saline implant deflation is relatively easy to detect because it presents with a rapid decrease in breast size on the affected side. Ruptures of silicone gel–filled implants, by contrast, can go undetected for years—hence the term silent rupture applied in this circumstance.3 If a rupture is detected, the faulty breast implant is removed and returned to the manufacturer for investigation.
If surgical instrumentation leads to a puncture during saline gel–filled implant surgery, it is usually noticed immediately. A silicone gel–filled implant can also be punctured during the implantation procedure, often with no obvious signs of the rupture.
Rupture of a silicone gel–filled implant may be intracapsular or extracapsular. In intracapsular ruptures, the contents of the implant remain within the capsule that has formed around the implant. Extracapsular ruptures involve migration of the silicone material outside the capsule.3 Current-generation silicone implants are increasingly biodurable, thereby reducing the risk for silicone migration.26,27
MRI is currently considered the study of choice to detect silent rupture of a silicone gel–filled implant.28 As primary care providers should be aware, the FDA recommends that women with silicone gel–filled implants undergo MRI screening three years after implantation and every two years thereafter to assess the implants’ integrity.17 This applies to all age-groups and does not replace screening mammography requirements for breast cancer.
While mammography is ideal for detecting extracapsular silicone implant ruptures, it fails to detect intracapsular implant rupture consistently.29 Breast ultrasound cannot effectively detect ruptures in the posterior portion of the implant and cannot evaluate the chest wall. Thus, MRI, with its high spatial resolution and marked contrast between implants and natural breast tissue, is considered most effective in detecting either intracapsular or extracapsular ruptures.3,28,29
Despite earlier reports that implant rupture could prompt an immunologic reaction, giving rise to autoimmune or related diseases, subsequent studies reveal “no association between silicone gel–filled breast implants and connective tissue disease, breast cancer, or reproductive problems.”17 Apart from a relatively low risk for silicone migration, implant rupture has been deemed relatively harmless.30
Implant Wrinkling, Folding
Implant wrinkling visible to the naked eye can mar the aesthetic appearance of an augmented breast. In some cases, the wrinkled implant may be detected only by palpation. Causes of wrinkling include:
• Thin skin and insufficient natural breast tissue, especially in the lower outer pole
• Subglandular placement of the implant, which allows less coverage over the implant than submuscular placement; and
• Use of saline-filled or textured-surface implants.
Because saline has a lower viscosity than silicone, it may allow lower-pole expansion and settling—and hence, wrinkling. Insufficient filling in saline implants may contribute to the problem, in addition to palpable shell folding, palpable shifts of filler material, sloshing, and other compromised aesthetic results.3,31
In rare cases, wrinkling over thin skin can cause implant extrusion. Additionally, the friction created as the shell rubs against itself can cause implant deflation or even rupture due to the development of a “hot spot.”
Options to address implant wrinkling are to replace saline-filled implants with silicone gel–filled implants or to revise placement of the implant from the subglandular to the submuscular location. Use of acellular dermal matrix can help reinforce existing breast tissue, especially when placed in the lower pole of the affected breast.32,33
Anaplastic Large-Cell Lymphoma
Of rising concern is a possible association between certain breast implants (ie, textured vs nontextured implants; silicone vs saline implants) and anaplastic large-cell lymphoma (ALCL).9-13 RAND Health14 sponsored a study conducted by 10 multidisciplinary experts, who agreed on the following points:
(1) A positive association exists between breast implants and ALCL, with the actual number of cases probably underrecognized.
(2) Any recurrent, clinically evident seroma developing longer than six months after breast implantation should be aspirated for cytologic analysis.
(3) Anaplastic lymphoma kinase (ALK)–negative ALCL that develops in the vicinity of breast implants is distinct from systemic ALK-negative ALCL, is clinically indolent disease, and has a favorable prognosis.
(4) Management of ALCL requires removal of the involved implant and capsule (a strategy that is likely to prevent recurrence) and evaluation for the disease at other sites.
(5) Adjuvant radiation or chemotherapy need not be offered to women with capsule-confined disease.13,14
Currently, the FDA has called for further research, concluding, “it is not possible to confirm with statistical certainty that breast implants cause ALCL.”11
Because occurrence of ALCL is rare, the absolute risk for the disease may be extremely low. However, primary care providers who detect a seroma or note increased size in one augmented breast over another six months or longer after an augmentation procedure are advised to refer the patient to a plastic surgeon or other appropriate specialist.11
All cases of confirmed ALCL in women with breast implants should be reported to [email protected]. This is a registry begun by the FDA, in conjunction with the Plastic Surgery Foundation and the American Society of Plastic Surgeons, to gather data about ALCL in women with breast implants.
History of Breast Implant Regulation
Silicone gel–filled implants, introduced in the US in 1962, were classified as moderate-risk (Class II) medical devices when Congress passed the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act.17 In the 1980s, concerns regarding the safety of breast implants led to extensive studies. Data from the FDA’s surveillance systems and published case reports led the FDA to upgrade silicone breast implants to a Class III device (presenting “a potential unreasonable risk of illness or injury”), which requires premarket approval.16
In 1992, the FDA removed silicone breast implants from the market for primary augmentation purposes due to persistent concerns about patient safety. From 1992 to 2006, silicone breast implants remained available only for breast reconstruction after mastectomy, correction of congenital deformities, or replacement of existing implants.17 Women who agreed to undergo breast augmentation with silicone gel–filled implants were enrolled in safety studies conducted by the implant manufacturers. Saline implants remained on the market with no limitations on use, but additional studies on these implants were also ordered.
In 1999, the Institute of Medicine (IOM) released a report, “Safety of Silicone Breast Implants,”18 which more clearly delineated the complications associated with silicone gel–filled implant use. The authors concluded that local complications, including implant rupture and capsular contracture, were the primary associated safety issues. Furthermore, the authors of the IOM report found no causal relationship between silicone gel–filled implants and systemic diseases, such as autoimmune disorders or cancer.2,18
In 2006, the FDA restored approval of silicone gel–filled implants, based largely on core studies conducted by the implant manufacturers.15,19,20 “Despite frequent local complications and adverse outcomes,” it was noted, “the FDA determined that the benefits and risks of breast implants were sufficiently understood for women to make informed decisions about their use.”17 The FDA required the manufacturers to continue with several postapproval studies.15
The complications and adverse outcomes most frequently observed in these studies were capsular contracture, reoperation, removal of implant, and implant rupture.17 Revision and reconstruction surgeries typically have higher complication rates than do primary augmentation surgeries.2
Less Common Complications
In synmastia, a rare but serious complication, the breasts become conjoined because the natural intermammary sulcus (the cleft between the breasts) is obliterated. Causative and contributing factors include aggressive medical resection of the breast, medial migration of either or both implants, selection of a breast implant that is too large for the chest wall, a history of multiple breast surgeries, and a chest wall deformity called pectus excavatum.34 Treatment for synmastia is generally surgical. The main goals of surgical treatment are restoration of the initial presternal subcutaneous integrity and medial closure of the pocket.34,35
Bottoming outsimply means descent of the breast implant on the chest wall sufficient to compromise the inframammary fold. Early bottoming out is most likely due to overdissection or insufficient dissection of the implant pocket, whereas later occurrence is generally attributed to the weight of the implant, compromised breast tissue, or poor skin quality. Surgical revision is needed to elevate and reinforce the inframammary fold. As in the case of implant wrinkling, acellular dermal matrix can be added to bolster breast tissue and prevent tissue thinning (and reduce the risk for implant extrusion).32,33
Mondor’s cordsare firm, cord-like bands caused by superficial thrombophlebitis that can involve the lateral thoracic vein, thoracoepigastric vein, or superior epigastric vein.36,37 This condition presents with abrupt-onset pain in the breast or chest wall, preceded by the appearance of a firm, tender cord. Mondor’s cords usually resolve spontaneously but may be treated with warm compresses, NSAIDs, and use of a supportive bra.37
Conclusion
Breast implants are among the most thoroughly studied medical devices. Although systemic complications are sensationalized in the media, local complications are much more prevalent. The primary care provider is often the first clinician to identify complications of breast augmentation, especially beyond the one-year postprocedure period. Thus, primary care providers must be aware of the local complications that may arise.
Anaplastic large-cell lymphoma is being studied as a possible complication of breast augmentation. Clinicians should be alert to possible development of a seroma six months or longer after an augmentation procedure.
References
1.
13.8 million cosmetic plastic surgery procedures performed in 2011 [press release]. Arlington Heights, IL: American Society of Plastic Surgeons; February 9, 2012.
2. FDA. Medical devices: risks of breast implants (2013). www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/Breastimplants/ucm064106.htm. Accessed May 14, 2013.
3. Juanpere S, Perez E, Huc O, et al. Imaging of breast implants: a pictorial review. Insights Imaging. 2011;2:653-690.
4. Adams WP Jr. Capsular contracture: what is it? What causes it? How can it be prevented and managed? Clin Plast Surg. 2009;36:119-126.
5. El-Sheikh Y, Tutino R, Knight C, et al. Incidence of capsular contracture in silicone versus saline cosmetic augmentation mammoplasty: a meta-analysis. Can J Plast Surg. 2008;16:211-215.
6. Blount AL, Martin MD, Lineberry KD, et al. Capsular contracture rate in a low-risk population after primary augmentation mammaplasty. Aesthet Surg J. 2013;33:516-521.
7. Schaub TA, Ahmad J, Rohrich RJ. Capsular contracture with breast implants in the cosmetic patient: saline versus silicone—a systematic review of the literature. Plast Reconstr Surg. 2010;126:2140-2149.
8. Hvilsom GB, Hölmich LR, Henriksen TF, et al. Local complications after cosmetic breast augmentation: results from the Danish Registry for Plastic Surgery of the Breast. Plast Reconstr Surg. 2009;124:919-925.
9. Thompson PA, Lade S, Webster H, et al. Effusion-associated anaplastic large cell lymphoma of the breast: time for it to be defined as a distinct clinico-pathological entity. Haematologica. 2010;95:1977-1979.
10. Brody GS, Deapen D, Gill P, et al. T-cell non-Hodgkin’s anaplastic lymphoma associated with one style of breast implants. Presented at: American Society of Plastic Surgeons Annual Conference; March 20-23, 2010; San Antonio, Texas. Abstract 42.
11. FDA, Center for Devices and Radiological Health. Anaplastic large cell lymphoma (ALCL) in women with breast implants: preliminary FDA findings and analyses (2011). www.fda.gov/MedicalDevices/ProductsandMedical Procedures/ImplantsandProsthetics/BreastImplants/ucm239996.htm. Accessed May 14, 2013.
12. Carty MJ, Pribaz JJ, Antin JH, et al. A patient death attributable to implant-related primary anaplastic large cell lymphoma of the breast. Plast Reconstr Surg. 2011;128:112e-118e.
13. Kim B, Roth C, Young VL, et al. Anaplastic large cell lymphoma and breast implants: results from a structured expert consultation process. Plast Reconstr Surg. 2011;128:629-639.
14. Kim B, Roth CP, Chung KC, et al. Are breast implants linked to a rare form of lymphoma? www.rand.org/pubs/research_briefs/RB9584.html. Accessed May 14, 2013.
15. Silicone gel-filled breast implants approved. FDA Consum. 2007;41:8-9.
16. Johnson JA; Congressional Research Service. FDA regulation of medical devices (2012). www.fas.org/sgp/crs/misc/R42130.pdf. Accessed May 14, 2013.
17. FDA. Update on the safety of silicone gel–filled breast implants (2011). www.fda.gov/downloads/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/UCM260090.pdf. Accessed May 14, 2013.
18. Bondurant S, Ernster V, Herdman R, eds; Committee on the Safety of Silicone Breast Implants, Division of Health Promotion and Disease Prevention, Institute of Medicine. Washington, DC: National Academy Press; 1999.
19. Spear SL, Hedén P. Allergan’s silicone gel breast implants. Expert Rev Med Devices. 2007;4:699-708.
20. Cunningham B. The Mentor core study on silicone MemoryGel breast implants. Plast Reconstr Surg. 2007;120(7 suppl 1):19S-32S.
21. Spear SL, Baker JL Jr. Classification of capsular contracture after prosthetic breast reconstruction. Plast Reconstr Surg. 1995;96:1119-1123.
22. Schreml S, Heine N, Eisenmann-Klein M, Pranti L. Bacterial colonization is of major relevance for high-grade capsular contracture after augmentation mammaplasty. Ann Plast Surg. 2007;59:126-130.
23. Siggelkow W, Faridi A, Spiritus K, et al. Histological analysis of silicone breast implant capsules and correlation with capsular contracture. Biomaterials. 2003;24:1101-1109.
24. Henriksen TF, Fryzek JP, Hölmich LR, et al. Surgical intervention and capsular contracture after breast augmentation: a prospective study of risk factors. Ann Plast Surg. 2005;54:343-351.
25. Amano Y, Aoki R, Kumita S, Kumazaki T. Silicone-selective multishot echo-planar imaging for rapid MRI survey of breast implants. Eur Radiol. 2007;17:1875-1878.
26. Maxwell GP, Van Natta BW, Murphy DK, et al. Natrelle style 410 form-stable silicone breast implants: core study results at 6 years. Aesthet Surg J. 2012;32:709-717.
27. Stevens WG, Harrington J, Alizadeh K, et al. Five-year follow-up data from the US clinical trial for Sientra’s U.S. Food and Drug Administration-approved Silimed® brand round and shaped implants with high-strength silicone gel. Plast Reconstr Surg. 2012;130:973-981.
28. Hold PM, Alam S, Pilbrow WJ, et al. How should we investigate breast implant rupture? Breast J. 2012;18:253-256.
29. Everson LI, Parantainen H, Detlie T, et al. Diagnosis of breast implant rupture: imaging findings and relative efficacies of imaging techniques. AJR Am J Roentgenol. 1994;163:57-60.
30. Hölmich LR, Vejborg IM, Conrad C, et al. Untreated silicone breast implant rupture. Plast Reconstr Surg. 2004;114:204-214.
31. Dowden RV, Reisman NR. Breast implant overfill, optimal fill, and the standard of care. Plast Reconstr Surg. 1999;104:1185-1186.
32. Spear SL, Sinkin JC, Al-Attar A. Porcine acellular dermal matrix (Strattice™) in primary and revision cosmetic breast surgery. Plast Reconstr Surg. 2013;131:1140-1148.
33. Shestak KC. Acellular dermal matrix inlays to correct significant implant malposition in patients with compromised local tissues. Aesthet Surg J. 2011;31(7 suppl):85S-94S.
34. Spear SL, Bogue DP, Thomassen JM. Synmastia after breast augmentation. Plast Reconstr Surg. 2006;118(7 suppl):168S-171S.
35. Selvaggi G, Giordano S, Ishak L. Synmastia: prevention and correction. Ann Plast Surg. 2010;65:455-461.
36. Coscia J, Lance S, Wong M, Garcia J. Mondor’s thrombophlebitis 13 years after breast augmentation. Ann Plast Surg. 2012;68:336-337.
37. Dudrap E, Milliez PY, Auquit-Auckbur I, Bony-Rerolle S. Mondor’s disease and breast plastic surgery [in French]. Ann Chir Plast Esthet. 2010; 55:233-237.
Breast augmentation is one of the most commonly performed plastic surgery procedures. It is important for primary care providers who perform clinical breast exams to be well versed in complications that can occur after the immediate postsurgical period and to prepare patients with augmented breasts for the likelihood of requiring a secondary procedure at some time.
Breast augmentation continues to rank as the procedure most commonly performed by US plastic surgeons. According to data from the American Society of Plastic Surgeons,1 307,000 breast augmentation procedures were performed in the US in 2011—a 4% increase from the previous year. Breast implants are not permanent devices, and most patients can expect to undergo a secondary procedure during their lifetime.2
Hematomas and infections associated with breast augmentation usually occur within two to 14 days following surgery, while the patient is still under the care of the plastic surgeon.2,3 For long-term complications, however, patients are likely to consult their primary care or gynecologic provider. Thus, it is important that any clinician who performs clinical breast exams be well versed in the complications, both local and systemic, that can occur after the immediate postsurgical period in patients who have undergone breast augmentation.
Common Complications of Breast Enhancement
Complications after breast augmentation are not uncommon. They can occur in women with either silicone gel– or saline-filled implants; conflicting incidence rates for capsular contracture (the most common local complication3,4) have been reported following insertion of silicone gel–filled implants, compared with saline implants.5,6 It has been noted, however, that prospective data comparing the two implant types are lacking in the literature.7
Complications can be categorized as either local or systemic. In addition to capsular contracture, local complications (which are more common) include implant rupture or deflation, and implant rippling or wrinkling.
Systemic complications may include anaplastic large-cell lymphoma, a rare but serious complication that is currently under study for its potential association with breast implants8 (see third article in this series, “Anaplastic Large-Cell Lymphoma”9-14). Other systemic sequelae include autoimmune disorders, connective tissue disease, and fibrositis/fibromyalgia conditions; these conditions can only be addressed in an article of greater scope.
In 2006, breast implant manufacturers were mandated to conduct postapproval studies regarding the devices’ safety15 (see fourth article in this series, “History of Breast Implant Regulation,”2,15-20). Findings from these studies can facilitate primary care providers’ management of patients who have augmented breasts.
Capsular Contracture
Capsular contracture occurs with frequencies ranging from 1.9% to 2.3%.8 As a result of the immune response to any foreign body, collagen fibers form and weave around the prosthetic device once it is implanted. For reasons not completely understood, these fibers can begin to tighten over time. As the capsule continues to tighten and harden, the implant is then compressed, resulting in breast pain and deformity.
The degree of capsular contracture is categorized according to Baker’s classification system regarding implant position and breast firmness postaugmentation.2,21 A Baker’s grade I designation implies that the modified breast is soft and looks normal. Grade II describes a breast that is slightly firm upon exam but looks completely normal. In grade III, the breast is firm and has taken on an abnormal appearance. In grade IV, the breast looks abnormal and is firm on examination, with the patient describing significant pain.
Some researchers believe that capsular contracture develops because of a subclinical bacterial infection, while others suggest that silicone leakage may be the cause.6,22,23 A patient who is diagnosed with a hematoma during the postoperative period is at increased risk for capsular contracture, and one who has been treated previously for capsular contracture has a significant risk for recurrence.2,24
Capsular contracture is usually treated surgically by a capsulectomy or a capsulotomy. Currently, the preferred procedure is an open capsulectomy to remove the implant, surgically excise the entire capsule, and replace the implant.4
Implant Deflation, Rupture
Most ruptures of implants (whether they are used cosmetically or for reconstruction) occur between 10 and 15 years after implantation.3,25 Incidence of implant removal by 10 years postsurgery ranges from 21% to 32% for silicone gel–filled implants, depending on the specific implant model.17
Saline implant deflation is relatively easy to detect because it presents with a rapid decrease in breast size on the affected side. Ruptures of silicone gel–filled implants, by contrast, can go undetected for years—hence the term silent rupture applied in this circumstance.3 If a rupture is detected, the faulty breast implant is removed and returned to the manufacturer for investigation.
If surgical instrumentation leads to a puncture during saline gel–filled implant surgery, it is usually noticed immediately. A silicone gel–filled implant can also be punctured during the implantation procedure, often with no obvious signs of the rupture.
Rupture of a silicone gel–filled implant may be intracapsular or extracapsular. In intracapsular ruptures, the contents of the implant remain within the capsule that has formed around the implant. Extracapsular ruptures involve migration of the silicone material outside the capsule.3 Current-generation silicone implants are increasingly biodurable, thereby reducing the risk for silicone migration.26,27
MRI is currently considered the study of choice to detect silent rupture of a silicone gel–filled implant.28 As primary care providers should be aware, the FDA recommends that women with silicone gel–filled implants undergo MRI screening three years after implantation and every two years thereafter to assess the implants’ integrity.17 This applies to all age-groups and does not replace screening mammography requirements for breast cancer.
While mammography is ideal for detecting extracapsular silicone implant ruptures, it fails to detect intracapsular implant rupture consistently.29 Breast ultrasound cannot effectively detect ruptures in the posterior portion of the implant and cannot evaluate the chest wall. Thus, MRI, with its high spatial resolution and marked contrast between implants and natural breast tissue, is considered most effective in detecting either intracapsular or extracapsular ruptures.3,28,29
Despite earlier reports that implant rupture could prompt an immunologic reaction, giving rise to autoimmune or related diseases, subsequent studies reveal “no association between silicone gel–filled breast implants and connective tissue disease, breast cancer, or reproductive problems.”17 Apart from a relatively low risk for silicone migration, implant rupture has been deemed relatively harmless.30
Implant Wrinkling, Folding
Implant wrinkling visible to the naked eye can mar the aesthetic appearance of an augmented breast. In some cases, the wrinkled implant may be detected only by palpation. Causes of wrinkling include:
• Thin skin and insufficient natural breast tissue, especially in the lower outer pole
• Subglandular placement of the implant, which allows less coverage over the implant than submuscular placement; and
• Use of saline-filled or textured-surface implants.
Because saline has a lower viscosity than silicone, it may allow lower-pole expansion and settling—and hence, wrinkling. Insufficient filling in saline implants may contribute to the problem, in addition to palpable shell folding, palpable shifts of filler material, sloshing, and other compromised aesthetic results.3,31
In rare cases, wrinkling over thin skin can cause implant extrusion. Additionally, the friction created as the shell rubs against itself can cause implant deflation or even rupture due to the development of a “hot spot.”
Options to address implant wrinkling are to replace saline-filled implants with silicone gel–filled implants or to revise placement of the implant from the subglandular to the submuscular location. Use of acellular dermal matrix can help reinforce existing breast tissue, especially when placed in the lower pole of the affected breast.32,33
Anaplastic Large-Cell Lymphoma
Of rising concern is a possible association between certain breast implants (ie, textured vs nontextured implants; silicone vs saline implants) and anaplastic large-cell lymphoma (ALCL).9-13 RAND Health14 sponsored a study conducted by 10 multidisciplinary experts, who agreed on the following points:
(1) A positive association exists between breast implants and ALCL, with the actual number of cases probably underrecognized.
(2) Any recurrent, clinically evident seroma developing longer than six months after breast implantation should be aspirated for cytologic analysis.
(3) Anaplastic lymphoma kinase (ALK)–negative ALCL that develops in the vicinity of breast implants is distinct from systemic ALK-negative ALCL, is clinically indolent disease, and has a favorable prognosis.
(4) Management of ALCL requires removal of the involved implant and capsule (a strategy that is likely to prevent recurrence) and evaluation for the disease at other sites.
(5) Adjuvant radiation or chemotherapy need not be offered to women with capsule-confined disease.13,14
Currently, the FDA has called for further research, concluding, “it is not possible to confirm with statistical certainty that breast implants cause ALCL.”11
Because occurrence of ALCL is rare, the absolute risk for the disease may be extremely low. However, primary care providers who detect a seroma or note increased size in one augmented breast over another six months or longer after an augmentation procedure are advised to refer the patient to a plastic surgeon or other appropriate specialist.11
All cases of confirmed ALCL in women with breast implants should be reported to [email protected]. This is a registry begun by the FDA, in conjunction with the Plastic Surgery Foundation and the American Society of Plastic Surgeons, to gather data about ALCL in women with breast implants.
History of Breast Implant Regulation
Silicone gel–filled implants, introduced in the US in 1962, were classified as moderate-risk (Class II) medical devices when Congress passed the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act.17 In the 1980s, concerns regarding the safety of breast implants led to extensive studies. Data from the FDA’s surveillance systems and published case reports led the FDA to upgrade silicone breast implants to a Class III device (presenting “a potential unreasonable risk of illness or injury”), which requires premarket approval.16
In 1992, the FDA removed silicone breast implants from the market for primary augmentation purposes due to persistent concerns about patient safety. From 1992 to 2006, silicone breast implants remained available only for breast reconstruction after mastectomy, correction of congenital deformities, or replacement of existing implants.17 Women who agreed to undergo breast augmentation with silicone gel–filled implants were enrolled in safety studies conducted by the implant manufacturers. Saline implants remained on the market with no limitations on use, but additional studies on these implants were also ordered.
In 1999, the Institute of Medicine (IOM) released a report, “Safety of Silicone Breast Implants,”18 which more clearly delineated the complications associated with silicone gel–filled implant use. The authors concluded that local complications, including implant rupture and capsular contracture, were the primary associated safety issues. Furthermore, the authors of the IOM report found no causal relationship between silicone gel–filled implants and systemic diseases, such as autoimmune disorders or cancer.2,18
In 2006, the FDA restored approval of silicone gel–filled implants, based largely on core studies conducted by the implant manufacturers.15,19,20 “Despite frequent local complications and adverse outcomes,” it was noted, “the FDA determined that the benefits and risks of breast implants were sufficiently understood for women to make informed decisions about their use.”17 The FDA required the manufacturers to continue with several postapproval studies.15
The complications and adverse outcomes most frequently observed in these studies were capsular contracture, reoperation, removal of implant, and implant rupture.17 Revision and reconstruction surgeries typically have higher complication rates than do primary augmentation surgeries.2
Less Common Complications
In synmastia, a rare but serious complication, the breasts become conjoined because the natural intermammary sulcus (the cleft between the breasts) is obliterated. Causative and contributing factors include aggressive medical resection of the breast, medial migration of either or both implants, selection of a breast implant that is too large for the chest wall, a history of multiple breast surgeries, and a chest wall deformity called pectus excavatum.34 Treatment for synmastia is generally surgical. The main goals of surgical treatment are restoration of the initial presternal subcutaneous integrity and medial closure of the pocket.34,35
Bottoming outsimply means descent of the breast implant on the chest wall sufficient to compromise the inframammary fold. Early bottoming out is most likely due to overdissection or insufficient dissection of the implant pocket, whereas later occurrence is generally attributed to the weight of the implant, compromised breast tissue, or poor skin quality. Surgical revision is needed to elevate and reinforce the inframammary fold. As in the case of implant wrinkling, acellular dermal matrix can be added to bolster breast tissue and prevent tissue thinning (and reduce the risk for implant extrusion).32,33
Mondor’s cordsare firm, cord-like bands caused by superficial thrombophlebitis that can involve the lateral thoracic vein, thoracoepigastric vein, or superior epigastric vein.36,37 This condition presents with abrupt-onset pain in the breast or chest wall, preceded by the appearance of a firm, tender cord. Mondor’s cords usually resolve spontaneously but may be treated with warm compresses, NSAIDs, and use of a supportive bra.37
Conclusion
Breast implants are among the most thoroughly studied medical devices. Although systemic complications are sensationalized in the media, local complications are much more prevalent. The primary care provider is often the first clinician to identify complications of breast augmentation, especially beyond the one-year postprocedure period. Thus, primary care providers must be aware of the local complications that may arise.
Anaplastic large-cell lymphoma is being studied as a possible complication of breast augmentation. Clinicians should be alert to possible development of a seroma six months or longer after an augmentation procedure.
References
1.
13.8 million cosmetic plastic surgery procedures performed in 2011 [press release]. Arlington Heights, IL: American Society of Plastic Surgeons; February 9, 2012.
2. FDA. Medical devices: risks of breast implants (2013). www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/Breastimplants/ucm064106.htm. Accessed May 14, 2013.
3. Juanpere S, Perez E, Huc O, et al. Imaging of breast implants: a pictorial review. Insights Imaging. 2011;2:653-690.
4. Adams WP Jr. Capsular contracture: what is it? What causes it? How can it be prevented and managed? Clin Plast Surg. 2009;36:119-126.
5. El-Sheikh Y, Tutino R, Knight C, et al. Incidence of capsular contracture in silicone versus saline cosmetic augmentation mammoplasty: a meta-analysis. Can J Plast Surg. 2008;16:211-215.
6. Blount AL, Martin MD, Lineberry KD, et al. Capsular contracture rate in a low-risk population after primary augmentation mammaplasty. Aesthet Surg J. 2013;33:516-521.
7. Schaub TA, Ahmad J, Rohrich RJ. Capsular contracture with breast implants in the cosmetic patient: saline versus silicone—a systematic review of the literature. Plast Reconstr Surg. 2010;126:2140-2149.
8. Hvilsom GB, Hölmich LR, Henriksen TF, et al. Local complications after cosmetic breast augmentation: results from the Danish Registry for Plastic Surgery of the Breast. Plast Reconstr Surg. 2009;124:919-925.
9. Thompson PA, Lade S, Webster H, et al. Effusion-associated anaplastic large cell lymphoma of the breast: time for it to be defined as a distinct clinico-pathological entity. Haematologica. 2010;95:1977-1979.
10. Brody GS, Deapen D, Gill P, et al. T-cell non-Hodgkin’s anaplastic lymphoma associated with one style of breast implants. Presented at: American Society of Plastic Surgeons Annual Conference; March 20-23, 2010; San Antonio, Texas. Abstract 42.
11. FDA, Center for Devices and Radiological Health. Anaplastic large cell lymphoma (ALCL) in women with breast implants: preliminary FDA findings and analyses (2011). www.fda.gov/MedicalDevices/ProductsandMedical Procedures/ImplantsandProsthetics/BreastImplants/ucm239996.htm. Accessed May 14, 2013.
12. Carty MJ, Pribaz JJ, Antin JH, et al. A patient death attributable to implant-related primary anaplastic large cell lymphoma of the breast. Plast Reconstr Surg. 2011;128:112e-118e.
13. Kim B, Roth C, Young VL, et al. Anaplastic large cell lymphoma and breast implants: results from a structured expert consultation process. Plast Reconstr Surg. 2011;128:629-639.
14. Kim B, Roth CP, Chung KC, et al. Are breast implants linked to a rare form of lymphoma? www.rand.org/pubs/research_briefs/RB9584.html. Accessed May 14, 2013.
15. Silicone gel-filled breast implants approved. FDA Consum. 2007;41:8-9.
16. Johnson JA; Congressional Research Service. FDA regulation of medical devices (2012). www.fas.org/sgp/crs/misc/R42130.pdf. Accessed May 14, 2013.
17. FDA. Update on the safety of silicone gel–filled breast implants (2011). www.fda.gov/downloads/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/UCM260090.pdf. Accessed May 14, 2013.
18. Bondurant S, Ernster V, Herdman R, eds; Committee on the Safety of Silicone Breast Implants, Division of Health Promotion and Disease Prevention, Institute of Medicine. Washington, DC: National Academy Press; 1999.
19. Spear SL, Hedén P. Allergan’s silicone gel breast implants. Expert Rev Med Devices. 2007;4:699-708.
20. Cunningham B. The Mentor core study on silicone MemoryGel breast implants. Plast Reconstr Surg. 2007;120(7 suppl 1):19S-32S.
21. Spear SL, Baker JL Jr. Classification of capsular contracture after prosthetic breast reconstruction. Plast Reconstr Surg. 1995;96:1119-1123.
22. Schreml S, Heine N, Eisenmann-Klein M, Pranti L. Bacterial colonization is of major relevance for high-grade capsular contracture after augmentation mammaplasty. Ann Plast Surg. 2007;59:126-130.
23. Siggelkow W, Faridi A, Spiritus K, et al. Histological analysis of silicone breast implant capsules and correlation with capsular contracture. Biomaterials. 2003;24:1101-1109.
24. Henriksen TF, Fryzek JP, Hölmich LR, et al. Surgical intervention and capsular contracture after breast augmentation: a prospective study of risk factors. Ann Plast Surg. 2005;54:343-351.
25. Amano Y, Aoki R, Kumita S, Kumazaki T. Silicone-selective multishot echo-planar imaging for rapid MRI survey of breast implants. Eur Radiol. 2007;17:1875-1878.
26. Maxwell GP, Van Natta BW, Murphy DK, et al. Natrelle style 410 form-stable silicone breast implants: core study results at 6 years. Aesthet Surg J. 2012;32:709-717.
27. Stevens WG, Harrington J, Alizadeh K, et al. Five-year follow-up data from the US clinical trial for Sientra’s U.S. Food and Drug Administration-approved Silimed® brand round and shaped implants with high-strength silicone gel. Plast Reconstr Surg. 2012;130:973-981.
28. Hold PM, Alam S, Pilbrow WJ, et al. How should we investigate breast implant rupture? Breast J. 2012;18:253-256.
29. Everson LI, Parantainen H, Detlie T, et al. Diagnosis of breast implant rupture: imaging findings and relative efficacies of imaging techniques. AJR Am J Roentgenol. 1994;163:57-60.
30. Hölmich LR, Vejborg IM, Conrad C, et al. Untreated silicone breast implant rupture. Plast Reconstr Surg. 2004;114:204-214.
31. Dowden RV, Reisman NR. Breast implant overfill, optimal fill, and the standard of care. Plast Reconstr Surg. 1999;104:1185-1186.
32. Spear SL, Sinkin JC, Al-Attar A. Porcine acellular dermal matrix (Strattice™) in primary and revision cosmetic breast surgery. Plast Reconstr Surg. 2013;131:1140-1148.
33. Shestak KC. Acellular dermal matrix inlays to correct significant implant malposition in patients with compromised local tissues. Aesthet Surg J. 2011;31(7 suppl):85S-94S.
34. Spear SL, Bogue DP, Thomassen JM. Synmastia after breast augmentation. Plast Reconstr Surg. 2006;118(7 suppl):168S-171S.
35. Selvaggi G, Giordano S, Ishak L. Synmastia: prevention and correction. Ann Plast Surg. 2010;65:455-461.
36. Coscia J, Lance S, Wong M, Garcia J. Mondor’s thrombophlebitis 13 years after breast augmentation. Ann Plast Surg. 2012;68:336-337.
37. Dudrap E, Milliez PY, Auquit-Auckbur I, Bony-Rerolle S. Mondor’s disease and breast plastic surgery [in French]. Ann Chir Plast Esthet. 2010; 55:233-237.