Breast implants A guide for general practice - RACGP
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Clinical
Breast implants
A guide for general practice
Alia Kaderbhai, Ashlea Broomfield, BREAST IMPLANTS have been in use second crisis related to implants occurred
Amanda Cuss, Karen Shaw, for reconstruction or augmentation in 2019–20. During this time, there was
Anand K Deva since 1962. Initial breast implants an increase in the number of cases of
were primarily silicone based with a breast implant–associated anaplastic
Background
smooth surface. In 1991, there was an large cell lymphoma (BIA-ALCL), a T-cell
Silicone breast implants have been increase in number of adverse events non-Hodgkin lymphoma, which resulted
used for post-mastectomy breast reported, including hardening, rupture in certain implant types being cancelled or
reconstruction and cosmetic and a possible link to autoimmune suspended worldwide.7–9
augmentation since the 1960s. Recent disease from silicone.1,2 Subsequently, It is also important to consider that
regulatory action has resulted in a few in 1992 the US regulator, the Food and some patients undergo breast implant
devices being suspended or cancelled
Drug Administration (FDA) imposed surgery overseas as part of a growing
from the Australian market.
a ‘voluntary moratorium’ on silicone cosmetic tourism industry. Recent
Objective breast implants, restricting their use to analysis has shown that cosmetic surgery
The aim of this article is to summarise breast reconstruction or for replacement performed overseas carries significantly
important clinical information on how
following device failure.1 This resulted higher risks of complications, notably
best to assess women with breast
in a large class action lawsuit.3 However, infection.10
implants, and recognise and manage
adverse events related to these devices. for the rest of the world, there are no
restrictions for silicone breast implants.
Discussion Since the early 1990s, newer technologies Types of breast implants
It is hoped that this article will be a
have been introduced, including the Breast implants can be classified based
valuable aid to primary care practice
in view of the increasing number of
texturisation of the outer shell, cohesive on their surface, fill and shape.
patients who will need ongoing gel fill and anatomic shapes (Figure 1).4
surveillance and care. Subsequent to the Dow Corning Implant surface
crisis, there have been two further major The outer shell of breast implants can vary
regulatory actions related to breast significantly. Initially, breast implants
implants. In 2010, a French-based were designed with a smooth outer shell.
implant manufacturer was found to be Texturisation was introduced in the late
using non-approved industrial-grade 1960s in an attempt to promote better
silicone.5 This resulted in the recall of tissue ingrowth and increase the implants’
products and government-sponsored stability and longevity. There are number
implant removal in the UK. The founder of different methods for imparting
of the company was tried, convicted and texture to the outer shell, including the
jailed. In Australia, the Poly Implant use of imprinting, salt impregnation, gas
Prothèse (PIP) crisis was the impetus vulcanisation and polyurethane coating.
for the establishment of the Australian Jones et al proposed a numeric grading
Breast Device Registry (ABDR).6 The system ranging from grade 1 (smooth)
484 Reprinted from AJGP Vol. 50, No. 7, July 2021 © The Royal Australian College of General Practitioners 2021
Breast implants: A guide for general practice Clinical
to grade 4 (polyurethane) based on the Breast augmentation remains the most usually in conjunction with oestrogen
measurement of surface area/roughness.11 popular elective cosmetic surgical supplementation.
procedure worldwide. Approximately For post-mastectomy reconstruction,
Implant fill 20,000 women undergo this procedure implants can be placed either immediately
Implants are typically filled with silicone each year in Australia, with 75% for following mastectomy or after a period
gel or less commonly saline. cosmetic augmentation and 25% for of tissue expansion. Expanders are used
reconstruction.12 Implants can be placed to stretch the skin/muscle pocket over a
Implant shape either above or partly below the pectoralis period of 3–6 months prior to conversion
Implants are round (or spherical) or major muscle and can be inserted using a definitive gel implant. The use
anatomic in shape. Anatomic implants via a submammary (most common), of mesh or dermal sheets to support the
require some surface texture to prevent peri-areolar or axillary incision. For implant can also be used to control implant
rotation in the pocket. women who have lost volume of the placement and/or reinforce the soft tissues.
breast, either through weight loss or
post-lactation, a breast lift (mastopexy)
Clinical use can be performed in combination with Complications following
Breast implants are used for four common augmentation. This will leave a visible breast implant insertion
indications: scar on the breast, usually in the shape Breast implants are not lifetime devices;
• cosmetic breast augmentation of an inverted T, or less commonly they have an estimated lifespan of
• post-mastectomy breast reconstruction around the areola. Implants are also 10–15 years. The risk of adverse events
• congenital deformities of the chest/breast used in transgender surgery (male begins to accumulate after the device
• transgender surgery. to female) to create a breast mound, is inserted (Figure 2). These can be
Figure 1. Generations of breast implants
© The Royal Australian College of General Practitioners 2021 Reprinted from AJGP Vol. 50, No. 7, July 2021 485
Clinical Breast implants: A guide for general practice
classified into local (breast or implant account for less than 5% of adverse fibrous capsule around the implant. The
related) versus systemic, and further events.12 Pain, swelling, redness, discharge principal cause of capsular contracture
subclassified into acute and medium/ and wound breakdown 1–2 weeks is the development and growth of a
long term. Table 1 summarises the local following surgery require urgent referral low-grade bacterial infection attached to
complications following breast implant to the treating doctor. Acute postoperative the surface of the implant (biofilm), which
surgery.12 In general, the risks associated infection requires early intervention with stimulates inflammation and fibrosis over
with post-mastectomy reconstruction are antibiotics, surgical debridement and time.14 Other postulated causes include
higher than with cosmetic augmentation. pocket irrigation to salvage the implant. If haematoma and/or foreign body reaction.
Added to this are the risks of radiation there is progression, however, the implant Patients present approximately 3–5 years
and/or chemotherapy that can increase is usually removed. It would be reasonable following initial surgery, and the rates
the risk of local implant complications. to attempt replacement following a period vary from 5% to 9% over 5–10 years’
Patients with associated comorbidities, of antibiotic therapy and tissue rest. post-implantation.15 The use of stringent
such as diabetes, obesity and smoking, bacterial mitigation (eg pocket irrigation
also increase the risk of adverse events, with antibiotics/antiseptic and ‘no touch’
especially infection. Capsular contracture insertion) when implants are placed in
Capsular contracture is the most common surgery has been shown to significantly
Acute complications reason for revision surgery (Figure 3).13 reduce the risk of capsular contracture.16–18
Infection, haematoma, implant exposure This presents as progressive hardening, Severe capsular contracture can cause
and seroma are acute complications distortion and deformity of the breast secondary implant rupture due to
following breast implant surgery and due to the development of a thick, infolding, friction and weakening of the
Figure 2. Adverse events resulting from breast implants
BIA-ALCL, breast implant–associated anaplastic large cell lymphoma
486 Reprinted from AJGP Vol. 50, No. 7, July 2021 © The Royal Australian College of General Practitioners 2021
Breast implants: A guide for general practice Clinical
outer shell. Capsular contracture is graded have some neuralgia from the axillary and swelling and pain approximately 7–8 years
clinically using the Baker grade (Table 2).19 lateral thoracic nerve branches. Nipple following the initial procedure (Figure 6).
sensitivity (either decreased sensation or In approximately 10–15% of women,
Implant rupture hyperaesthesia) can also occur following BIA-ALCL presents as a peri-implant
Disruption of the implant shell and leakage breast implant placement. mass, usually detectable on ultrasound,
of contents is termed ‘implant rupture’. which can subsequently spread to axillary
The contents can be held within the Breast implant–associated and mediastinal nodes. Currently, there
capsule (intracapsular) or leak into the anaplastic large cell lymphoma have been over 100 confirmed cases in
surrounding breast tissue and/or lymph Reports of a rare T-cell non-Hodgkin Australia with four deaths.23 The risk of
nodes (extracapsular). Extracapsular lymphoma occurring around breast BIA-ALCL is higher for implants with
rupture may present as an acute foreign implants have increased over the higher grades of texture.24 The current
body reaction with swelling, redness and past decade.19 It is not classified as a accepted hypothesis for causation proposes
induration of the breast and surrounding breast cancer. BIA-ALCL has now been that higher-grade texture provides a
chest wall. The patient may experience definitively linked to breast implants, template for the growth of bacteria,
a sudden change in shape or projection and more specifically, textured surface ultimately transforming genetically
of the breast, or in some cases may devices.7,9,20–22 Clinically, this tumour susceptible T cells into lymphoma over
be completely unaware of the rupture manifests most commonly as a malignant time.24 This theory is supported by
(termed ‘silent rupture’). This requires effusion with fluid build-up in the space clinical, laboratory and epidemiological
timely surgery for removal. Rupture is best between the implant and capsule, causing evidence. All women considering breast
detected by screening ultrasonography
and can be confirmed by magnetic
resonance imaging (MRI). Table 1. Local adverse events in women with breast implants
Implant mobility and visibility Implant related Breast related
The movement of the implant from its • Capsular contracture • Parenchymal ptosis: waterfall (Snoopy)
original pocket may cause visibility and/ deformity
• Rupture intracapsular/extracapsular/silent
or palpability of the implant outer shell. • Breast pain
• Rotation
This can manifest as a double bubble • Benign breast lumps
• Displacement: double bubble, axillary
appearance, where the implant moves
migration • Breast cancer
below the inframammary fold or into the
• Visibility/rippling
axilla (Figure 4). In some patients with very
• Deflation (saline filled)
thin parenchyma or weight loss following
• Folding
surgery, implant folding or rippling can also
• Breast implant–associated anaplastic large
be seen and felt. For anatomic implants,
cell lymphoma
rotation of the device can also cause
distortion of the breast shape.
Waterfall (Snoopy) deformity
This deformity occurs when the breast and
parenchyma drop below the position of
the implant (Figure 5). It can occur after
pregnancy/lactation and fluctuations in
weight. Treatment usually involves implant
exchange with a breast lift (mastopexy).
Breast pain
Pain in and around the breast implant is
usually related to capsular contracture.
Other causes of breast pain, including
breast lumps, fibrocystic change and
hormonally induced changes, can be timed
Figure 3. Right-sided grade 4 capsular Figure 4. Left-sided double bubble
with the menstrual cycle. Musculoskeletal contracture 10 years following primary
strain and costochondritis also need to be breast augmentation
considered. It is common after surgery to
© The Royal Australian College of General Practitioners 2021 Reprinted from AJGP Vol. 50, No. 7, July 2021 487
Clinical Breast implants: A guide for general practice
implant surgery should be informed of Once diagnosed, patients should be loss, myalgia, arthralgia, rashes, gastritis,
the relative risk of BIA-ALCL based on referred to a multidisciplinary team with hair loss, dyspnoea and loss of libido.26
the type of implant recommended. Latest expertise in breast cancer/reconstruction The term ‘breast implant illness’, which
evidence has estimated the risk as one in and be clinically staged using MRI/computed has coalesced as a term to describe this
2000–3000 for devices with a grade 3 tomography–positron emission tomography. condition, remains poorly characterised.
or 4 surface.25 To date, there are no cases In approximately 88% of women in Australia, Studies investigating likely pathogenesis,
arising from exposure to smooth (grade 1) the tumour is detected in the earliest stages, natural history and outcomes following
devices alone. The Australian regulator has when it is confined to the seroma and inner explantation are underway.26 Patients are
now cancelled grades 3 and 4 devices in lining of the capsule. For these patients, encouraged to register with one of these
response to this risk. surgical removal of the implant and capsule prospective trials.
A patient with suspected BIA-ALCL is curative. For more advanced disease,
should proceed to breast ultrasonography adjuvant chemotherapy, radiation therapy
and sampling of the peri-implant seroma. and immunotherapy are indicated. Clinical approach to
The presence of abnormal tumour cells breast implant assessment
that are CD30 positive and anaplastic Figure 7 outlines a clinical, investigative and
lymphoma kinase negative confirms the Breast implant illness management flowsheet for the assessment
diagnosis. For patients who present with Some women present with a range of of breast implants, and the diagnosis and
a mass and no effusion, ultrasound- systemic symptoms thought to be related management of non-acute complications.
guided biopsy or open biopsy can to breast implants. These symptoms are
confirm the diagnosis. diverse and include brain fog, memory History
All patients are now encouraged to keep
details of their implant on a patient card.
Table 2. Baker classification of capsular contracture18 Some patients may also be now registered
on the ABDR. A thorough history covering
Baker grade Description the following points should be taken:
1 Breast implant is soft and is not palpable and/or visible (for women with • Implant history: indication for surgery,
breast implants for reconstruction). Grade 1B is where the implant is soft date(s) of procedure(s), type of implant
but visible, as the skin envelope is thinner (size, surface, brand, shape), placement
of implant (above or below muscle),
2 Implant is palpable, but no visible deformity
name of treating practitioner and
3 Implant is hard, palpable and with some minor visibility (eg puckering, location of surgery
rippling, change in shape). Ultrasound usually shows infolding • Symptoms related to implant and/or
breast: pain, change in shape of breast,
4 Implant is very hard and painful with significant deformity of breast and/
hardness/palpable lumps, deformity,
or malposition. Ultrasound shows significant folding and/or rupture
change in sensation of nipple, nipple
discharge and skin abnormalities
• Systemic symptoms: fatigue, joint pains
and skin rashes
• Breast and reproductive history:
pregnancy, lactation/breastfeeding,
breast cancer/ovarian cancer history,
menstrual history and hormonal status
• Other concurrent illness
• Family history of cancer (including
lymphoma) and autoimmune disease
• Any recent imaging results.
Examination
Clinical examination should include
a thorough examination of the breast,
parenchyma and draining lymph nodes.
Visual inspection, with arms by the side
Figure 5. Waterfall deformity bilaterally shown Figure 6. Late right seroma. This patient
in three-quarter right view had benign pathology. She also had bilateral and raised above the head, of abnormal
waterfall (Snoopy) deformity. contour, visible lumps and skin changes
should be noted. The degree of capsular
488 Reprinted from AJGP Vol. 50, No. 7, July 2021 © The Royal Australian College of General Practitioners 2021
Breast implants: A guide for general practice Clinical
contracture can be clinically assessed for detecting implant rupture, seroma regular surveillance of women with breast
using the Baker grade (Table 2). The or any peri-implant or capsular mass. implants is becoming both recognised
presence of any asymmetry or associated A mammogram is also indicated if and recommended. Many surgeons now
chest wall abnormalities should also the patient has a high risk for breast conduct their own follow-up care for their
be noted and documented. It is good cancer or where a patient has not been patient cohort and have incorporated this
practice to document the appearance on previously screened. Many women with into their standard of care.
photographs with frontal, left and right breast implants wrongly assume that
three-quarter views (with the patient mammograms are not possible with
facing at a 45-degree angle) and right and implants in situ. A displacement technique Summary
left lateral views, if possible. can be used safely to protect the implant With a significant proportion of the
from damage. population accessing breast augmentation
Investigations At any stage in the work up, referral or reconstruction, it is useful for general
If there is a clinical abnormality, a to the original surgeon who placed the practitioners to become familiar with how
breast ultrasound is the gold standard implant should be considered. The need for to assess patients with breast implants
Figure 7. Clinical approach to the assessment of patients with breast implants, and the diagnosis and management of non-acute complications
CT-PET, computed tomography–positron emission tomography; MRI, magnetic resonance imaging; PROMS, patient-reported outcome measures
© The Royal Australian College of General Practitioners 2021 Reprinted from AJGP Vol. 50, No. 7, July 2021 489
Clinical Breast implants: A guide for general practice
and detect potential adverse events. In 8. Collett DJ, Rakhorst H, Lennox P, Magnusson M, 22. Doren EL, Miranda RN, Selber JC, et al. U.S.
Cooter R, Deva AK. Current risk estimate of Epidemiology of breast implant-associated
the aftermath of recent regulatory action, breast implant-associated anaplastic large anaplastic large cell lymphoma. Plast Reconstr
there are many understandably anxious cell lymphoma in textured breast implants. Surg 2017;139(5):1042–50. doi: 10.1097/
Plast Reconstr Surg 2019;143(3S A Review of PRS.0000000000003282.
patients who will require assessment and Breast Implant-Associated Anaplastic Large 23. Therapeutic Goods Administration. Breast
assurance, and in the event of a problem, Cell Lymphoma):30S–40S. doi: 10.1097/ implants and anaplastic large cell lymphoma
timely diagnosis and treatment. PRS.0000000000005567. Update – Suspended breast implant devices now
9. Magnusson M, Beath K, Cooter R, et al. The cancelled. Symonston, ACT: TGA, 2020. Available
epidemiology of breast implant-associated at www.tga.gov.au/alert/breast-implants-and-
anaplastic large cell lymphoma in Australia anaplastic-large-cell-lymphoma [Accessed 26
Authors and New Zealand confirms the highest risk February 2021].
Alia Kaderbhai MBBS, FRACGP, Chair, RACGP for grade 4 surface breast implants. Plast 24. Rastogi P, Deva AK, Prince HM. Breast implant-
Specific Interests Breast Medicine, Vic Reconstr Surg 2019;143(5):1285–92. doi: 10.1097/ associated anaplastic large cell lymphoma.
Ashlea Broomfield MBBS (Hons), DCH, FRACGP, PRS.0000000000005500. Curr Hematol Malig Rep 2018;13(6):516–24.
RACGP representative, NSW Health advisory 10. Venditto C, Gallagher M, Hettinger P, et al. doi: 10.1007/s11899-018-0478-2.
committee breast implant taskforce, NSW Complications of cosmetic surgery tourism: 25. Loch-Wilkinson A, Beath KJ, Magnusson MR,
Amanda Cuss BMedSci (Hons), MBBS (Hons), Case series and cost analysis. Aesthet Surg J et al. Breast implant-associated anaplastic large
BHealthSci, Senior Medical Advisor and Assistant 2020;sjaa092. doi: 10.1093/asj/sjaa092. cell lymphoma in Australia: A longitudinal study
Director, Devices Clinical Section, Health Products 11. Jones P, Mempin M, Hu H, et al. The functional of implant and other related risk factors. Aesthet
and Regulation Group, Therapeutic Goods influence of breast implant outer shell morphology Surg J 2020;40(8):838–46. doi: 10.1093/asj/
Administration, ACT on bacterial attachment and growth. Plast sjz333.
Karen Shaw BMedSci, MBBS (Hons), MS, Reconstr Surg 2018;142(4):837–49. doi: 10.1097/ 26. Magnusson MR, Cooter RD, Rakhorst H,
GradCertSurg(Breast), FRACS, Doctor, Faculty PRS.0000000000004801. McGuire PA, Adams WP Jr, Deva AK.
of Medicine and Health Sciences, Macquarie 12. Hopper I, Parker E, Pellegrini B, et al. The Breast implant illness: A way forward. Plast
University, Qld Australian breast device registry 2016 report. Reconstr Surg 2019;143(3S A review of
Anand K Deva BSc (Med), MBBS (Hons), MS, Melbourne, Vic: Monash University, Department breast implant-associated anaplastic large
FRACS, Professor, Faculty of Medicine and Health of Epidemiology and Preventive Medicine, 2018. cell lymphoma):74S–81S. doi: 10.1097/
Sciences, Macquarie University, NSW; Professor, 13. Wong CH, Samuel M, Tan BK, Song C. PRS.0000000000005573.
Integrated Specialist Healthcare Education and Capsular contracture in subglandular breast
Research Foundation, Integrated Care, NSW augmentation with textured versus smooth breast
Competing interests: AKD reports consulting and implants: A systematic review. Plast Reconstr
education from Mentor (Johnson & Johnson), advisory Surg 2006;118(5):1224–36. doi: 10.1097/01.
board fees from Allergen, educational resource fees prs.0000237013.50283.d2.
from Sientra and unrestricted research grants and 14. Tamboto H, Vickery K, Deva AK. Subclinical
consulting fees from Motiva (establishment labs) (biofilm) infection causes capsular
outside the submitted work. contracture in a porcine model following
Funding: None. augmentation mammaplasty. Plast Reconstr
Surg 2010;126(3):835–42. doi: 10.1097/
Providence and peer review: Not commissioned,
PRS.0b013e3181e3b456.
externally peer reviewed.
Correspondence to: 15. McGuire P, Reisman NR, Murphy DK. Risk factor
anand.deva@mq.edu.au analysis for capsular contracture, malposition,
and late seroma in subjects receiving Natrelle
410 form-stable silicone breast implants. Plast
References Reconstr Surg 2017;139(1):1–9. doi: 10.1097/
1. Deva AK, Cuss A, Magnusson M, Cooter R. The PRS.0000000000002837.
‘game of implants’: A perspective on the crisis- 16. Adams WP Jr, Conner WC, Barton FE Jr,
prone history of breast implants. Aesthet Surg J Rohrich RJ. Optimizing breast pocket irrigation:
2019;39(Suppl 1):S55–65. doi: 10.1093/asj/sjy310. An in vitro study and clinical implications. Plast
2. van Nunen SA, Gatenby PA, Basten A. Post- Reconstr Surg 2000;105(1):334–38; discussion
mammoplasty connective tissue disease. 339–43. doi: 10.1097/00006534-200001000-
Arthritis Rheum 1982;25(6):694–97. doi: 10.1002/ 00051.
art.1780250613. 17. Culbertson EJ, Felder-Scott C, Deva AK,
3. Fisher JC. Silicone on trial: Breast implants and Greenberg DE, Adams WP. Optimizing breast
the politics of risk. La Jolla, CA: Sager Group LLC, pocket irrigation: The breast implant-associated
2015. anaplastic large cell lymphoma (BIA-ALCL) era.
4. Champaneria MC, Wong WW, Hill ME, Gupta SC. Aesthet Surg J 2020;40(6):619–25. doi: 10.1093/
The evolution of breast reconstruction: A historical asj/sjz246.
perspective. World J Surg 2012;36(4):730–42. 18. Deva AK, Adams WP Jr, Vickery K. The role of
doi: 10.1007/s00268-012-1450-2. bacterial biofilms in device-associated infection.
5. Greco C. The poly implant prothèse breast Plast Reconstr Surg 2013;132(5):1319–28.
prosthesis scandal: Embodied risk and social doi: 10.1097/PRS.0b013e3182a3c105.
suffering. Soc Sci Med 2015;147:150–57. 19. Spear SL, Baker JL Jr. Classification of capsular
doi: 10.1016/j.socscimed.2015.10.068. contracture after prosthetic breast reconstruction.
6. Hopper I, Ahern S, Best RL, McNeil J, Cooter RD. Plast Reconstr Surg 1995;96(5):1119–23;
Australian breast device registry: Breast device discussion 1124.
safety transformed. ANZ J Surg 2017;87(1–2):9–10. 20. Miranda RN, Aladily TN, Prince HM, et al.
doi: 10.1111/ans.13819. Breast implant-associated anaplastic large-cell
7. Loch-Wilkinson A, Beath KJ, Knight RJW, lymphoma: Long-term follow-up of 60 patients.
et al. Breast implant-associated anaplastic J Clin Oncol 2014;32(2):114–20. doi: 10.1200/
large cell lymphoma in Australia and New JCO.2013.52.7911.
Zealand: High-surface-area textured implants 21. de Boer M, van der Sluis WB, de Boer JP, et al.
are associated with increased risk. Plast Breast implant-associated anaplastic large-cell
Reconstr Surg 2017;140(4):645–54. doi: 10.1097/ lymphoma in a transgender woman. Aesthet Surg
PRS.0000000000003654. J 2017;37(8):NP83–7. doi: 10.1093/asj/sjx098. correspondence ajgp@racgp.org.au
490 Reprinted from AJGP Vol. 50, No. 7, July 2021 © The Royal Australian College of General Practitioners 2021You can also read
