Summary
Modern breast implants are a staple of plastic surgery, finding uses in esthetic and reconstructive procedures. Their history began in the 1960s, with the first generation of smooth devices with thick silicone elastomer, thick silicone gel, and Dacron patches on the back. They presented hard consistency, high capsular contracture rates and the patches increased the risk of rupture. In the same decade, polyurethane coating of implants was implemented. A second generation was introduced in the 1970s with a thinner shell, less viscous gel filler and no patches, but increased silicone bleed-through and rupture rates. The third generation, in the early 1980s, featured implants with a thicker multilayered elastomer shell reinforced with silica to reduce rupture risk and prevent silicone bleed-through. A fourth generation from the late 1980s combined thick outer elastomer shells, more cohesive gel filler, and implemented for the first-time outer shell texturing. In the early 1990s, the fifth generation of devices pioneered an anatomical shape with highly cohesive form-stable gel filler and a rough outer shell surface. Surface texturing was hampered by the discovery of Breast Implant Associated-Anaplastic Large Cell Lymphoma and its link with textured devices. From the 2010s, we have the era of the sixth generation of implants, featuring innovations regarding the surface, with biomimetic surfaces, more resistant shells and variations in gel consistency. The road to innovation comprises setbacks such as the FDA moratorium in 1992, the PIP scandal, the Silimed CE mark temporary suspension and the FDA-requested voluntary recall of the Allergan BIOCELL implants.
Keywords
Abbreviations:
BI (Breast Implant), BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma)Introduction
The term “breast implant” (BI) refers to any implantable prosthesis used to modify or replace a person's breast contour, shape and size. Despite the great variability, they can be grouped according to three characteristics: fill, shell surface and three-dimensional shape.
In the European and American markets, they are most frequently filled with silicone gels of varying levels of cohesiveness, resulting in different viscosity and firmness. The second most commonly used filler material is saline solution. Less commonly used fillers include methylcellulose, soybean oil and others. All shells are made of silicone and fabricated by adding different layers (3–5) on top of each other to increase their strength against rupture or become impermeable to silicone, hindering bleed-through.
The external surface of the shell can have different aspect with different degrees of roughness, ranging from a non-perceptible one by touch (smooth), to a shallow or deep texturing, or it may also be coated with polyurethane (PU).
1
International Organization for Standardization. 2018. ISO 14607:2018(en) - non-active surgical implants — mammary implants — particular requirements. [online] Available at: https://www.iso.org/obp/ui/#iso:std:iso:14607:ed-3:v2:en [Accessed 6 January 2022].
Based on the above, several classifications mainly based on physical properties have been proposed. Barr et al. divided BIs according to surface roughness in Nano(<5 µm), Meso(<15 µm), Micro(10–75 µm), and Macro (>75 µm).
2
Although Atlan et al. used measurements of surface area to classify implants into Smooth (80–100 mm2), Micro (80–100 mm2), Macro (200–300 mm2), and +Macro (>300 mm2).3
Jones et al. instead, first introduced the integration of a biologic property as the bacterial attachment to surface with the physical measurements of roughness, to classify implants into Minimal (<25 µm), Low (25–75 µm), Intermediate (75–100 µm), and High (>150 µm).4
Today the most widely accepted classification remains the ISO 14607:2018, which divides surfaces based on their average roughness into Smooth (<10 µm), Micro (10–50 µm), and Macro (>50 µm).
1
Nevertheless, there is still need for a more comprehensive classification of implants integrating physical properties to their host interaction connected with most of BI complications (capsular contracture, BIA-ALCL).International Organization for Standardization. 2018. ISO 14607:2018(en) - non-active surgical implants — mammary implants — particular requirements. [online] Available at: https://www.iso.org/obp/ui/#iso:std:iso:14607:ed-3:v2:en [Accessed 6 January 2022].
Shape can either be round, a lenticular shape, with a symmetrical curved anterior side (dome) and a flat round posterior base; or anatomical, a teardrop shape, with the upper half having a lower projection compared to the enhanced projection of the lower half. They have an asymmetric curved anterior side and a flat, more often round or elliptic posterior base. These implants are filled with a highly cohesive gel to maintain their anatomical shape and are rough to prevent their rotation.
BIs undoubtedly represent a staple of plastic surgery, finding indications for both esthetic and reconstructive purposes. Their manufacturing has evolved significantly to overcome health concerns all the while accommodating the needs of patients, which is why they have gone through several iterations of changes.
5
,6
The aim of this paper was to present a recollection of the main BIs and relative events that paved the way to the development of modern BIs used today in the European and American markets, as well as the defining moments that will guide devices of the future.“Prehistory” – the dawn of breast implants
The first modern BI was introduced by Thomas Cronin and Frank Gerow in 1962, and the first generation of these devices was commercially produced using silicone by the Dow Corning Corporation, reaching US markets in 1964. They were manufactured with a smooth outer surface, a thick silicone elastomer (∼0.75 mm) shell filled with thick viscous polydimethylsiloxane (PDMS) silicone gel (composed of a mix of 50% low molecular weight chain [LMWC] components which are more fluid, and 50% high molecular weight chain [HMWC] components which are more viscous) and Dacron fixation patches on the posterior aspect to maintain their position.
7
Later the Dacron patches were deemed dangerous as they created a stress point at which the outer shell could tear,8
and the devices were performing too firm with an unnatural feel and a high capsular contracture rate. Soon after, in 1964, saline inflatable implants were developed by Laboratoires Arion,9
and because of their softer consistency gained a first wave of popularity in the 1970s as an alternative to Dow Corning BIs. However, they presented many cosmetic disadvantages and a much higher risk of deflation and implant failure, thus their market remained limited to the USA.10
,11
Natural-Y Surgical Specialties Inc. developed in 1964 and made available in 1968, the first type of silicone BI with an irregular sponge-like surface, coated by a 1 to 2 mm-thick layer of PU foam. This feature was intended to enhance tissue integration12
and counteract capsular contracture which plagued the previous generation of BIs.13
Their internal baffle was divided in the shape of a “Y” into 3 compartments, to minimize bulging of one compartment when another was compressed.14
In 1970s, silicone gel-filled Dow Corning implants were improved upon with a second generation having a thinner shell (∼0.13 mm), no Dacron patches and less viscous, low cohesion silicone gel (containing a mix of 80% LMWC and 20% HMWC).15
Although these BIs provided a more natural feel, their shell appeared to be permeable to silicone gel and they were subsequently plagued by microscopic bleeding and spreading of silicone droplets mainly to surrounding tissues and locoregional lymphonodes. In addition, they were less durable than their predecessors and ruptured frequently.16
,17
Importantly, these concerns and drawbacks, on one hand caused silicone BI regulations to shift in 1976, with the Food and Drug Administration (FDA) subjecting BIs to controls and performance standards with the enactment of the Medical Device Amendments,
18
whereas forced companies for further innovations.In 1976 Heyer-Schulte, in the attempt to overcome the silicone gel bleeding first introduced the “double lumen” BI, consisting of a silicone-filled core enclosed by a saline-filled outer shell.
19
This has paved the way for the introduction of a third generation of BIs in the 1980s, which implemented a thicker multilayered elastomer shell (0.28–0.3 mm) reinforced with silica to reduce implant rupture, prevent gel migration and stop silicone bleed-through. In 1984 Mentor manufactured a “reverse double lumen” implant also known as the Becker permanent expander, opposite to the previous produced by Heyer-Schulte.20
It consisted of a saline implant connected to a filling tube and a valve encased within a silicone implant, in an attempt to combine the esthetic benefits of silicone gel in the outer lumen with a postoperatively adjustable volume from the inner lumen, particularly advantageous in reconstructive and asymmetry cases.In spite of all the improvements, several reports of adverse events in patient with previous BIs began to appear in the medical literature” in the 1980s, and the FDA decided to designate BIs as class III medical devices with the Federal Register of June 24, 1988 (53 FR 23856): this implied that manufacturers needed rigorous approval from the FDA proving that their devices were medically safe before they could be sold and marketed.
21
Unfortunately the regulations arrived a little too late, as patients began suing manufacturing companies, arguing that the implants caused a variety of complications of which they had not been informed prior to surgery, including diseases of the immune system and breast cancer.US Food and Drug Administration. 2020. Saline, silicone gel, and alternative breast implants, guidance for industry and food and drug administration staff. [online] Available at: https://www.fda.gov/media/71081/download [Accessed 5 December 2021].
In the late 1980s, reports emerged also regarding the in vitro degradation of PU, which could lead to formation of 2,4-toluenediamine (2,4-TDA), known to be carcinogenic in animals, and raising concerns about its potential carcinogenicity in humans.
22
,23
The FDA, after performing a risk analysis, concluded that the lifetime risk of PU-induced cancer in women with a single pair of PU-coated BIs was about 1 in 1,000,000. This, according to the WHO definition of “acceptable cancer risk”,24
led the FDA to recommend that women with PU BIs should not have their devices removed based solely on concerns about cancer from 2,4-TDA.25
Although in 1991 the main PU-BI manufacturers Surgitek (subsequently Bristol-Myers Squibb) voluntarily withdrew its devices manufactured in the USA, which had been implanted in 110,000 American women by that time,U.S. Food and Drug Administration. 2004. FDA breast implant consumer handbook 2004: timeline of breast implant activities. [online] Available at: http://www.professor-graf.de/tl_files/professor-graf/Infos/Aesthetik/fdabreastprosthesis.pdf [Accessed 19 December 2021].
26
,27
foreign producers continued to manufacture PU-coated BIs outside the USA, and these devices have been widely used throughout Europe and other parts of the world in the following years.From late 1980s onwards, the fourth generations of BIs were developed with manufacturing criteria and quality control more stringent and rigorous than ever, due to the legislative FDA changes of 1988. The BIs included thick outer elastomer shells (∼0.5 mm), in some cases similar to that of previous generations of BIs, and a cohesive gel filler (manufacturer-specific) which was thought to be less likely to rupture and leak silicone.
28
They were most commonly round and with moderate cohesivity gel filler, and began implementing texturing of outer shells with different processes, including “salt-loss” and “imprint stamping” techniques to allow for more integration by tissue ingrowth into the irregular spaces of the shell.In 1990 Mentor licensed barrier technology to McGhan (subsequently Inamed and then Allergan from 2006) which began producing their own line of “double-lumen” devices similar to Heyer-Schult. However, the complex structure of these devices caused higher failure rates than previous BIs, and despite Mentor Becker expanders still being in distribution, double lumen implants began falling out of favor at the turn of the century.
29
By the early 1990s, Dow Corning was entangled in a litigation counting over 12,000 women who partook in a class-action lawsuit.
30
Pressured by media frenzy over BI litigation, the FDA evaluated that evidence supporting the safety and effectiveness of BIs was insufficient, and thus placed a temporary moratorium in January 1992, banning the use of silicone BIs in the USA.- Schleiter K.E.
Silicone breast implant litigation.
Virtual Mentor. 2010; 12 (Published 2010 May 1): 389-394https://doi.org/10.1001/virtualmentor.2010.12.5.hlaw1-1005
31
In April of the same year, the ban was revoked, but access to silicone BIs was limited to breast reconstruction, correction of congenital deformities and revisional cases. During the moratorium, saline inflatable BIs received some newfound popularity because they became the only option for esthetic breast augmentations in the USA, but never gained much popularity in the rest of the market where moratorium and limitation were not imposed.32
,33
Meanwhile, Dow Corning which was the world's largest implant manufacturer of its time, controlling 35% of the market, agreed to pay $3.2 billion as settlement with the claimants in 1994, but then later filed for bankruptcy in 1995 due to the number of lawsuits it was still facing. This effectively caused the corporate giant to withdraw from the implant market.34
Nevertheless, overwhelming research disproved the claims that BIs were linked with breast cancer and connective tissue diseases.35
,36
,37
Although the link with autoimmune and rheumatic diseases is up for debate, scientific evidence at the time failed to show that BIs caused disease, and after in-depth evaluation the FDA lifted the moratorium for good on November 2006, allowing the use of silicone BIs for women over the age of 22.38
,39
After lifting the moratorium, the FDA assessed results of core studies and approved in the USA only BIs produced by Allergan40
and Mentor.- Cunningham B.
- McCue J.
Safety and effectiveness of mentor's MemoryGel implants at 6 years.
Aesthet Plast Surg. 2009; 33 ([published correction appears in Aesthetic Plast Surg. 2009 May;33(3):439]): 440-444https://doi.org/10.1007/s00266-009-9364-6
41
“Middle ages” – the darkest hour of breast implants
A fifth generation of devices was introduced in 1993 with an anatomical teardrop or “gummy bear” shape and highly cohesive form-stable gel filler to maintain it,
42
combined with a rough outer surface of the shell (texturing) allowing for ingrowth and adherence with host tissues, necessary to stabilize implants in the correct position in the periprosthetic pocket.- Jewell M.L.
- Bengtson B.P.
- Smither K.
- Nuti G.
- Perry T.
Physical properties of silicone gel breast implants.
Aesthet Surg J. 2019; 39 ([published correction appears in Aesthet Surg J. 2019 Nov 13;39(12):NP552-NP553]): 264-275https://doi.org/10.1093/asj/sjy103
43
Some brands as Allergan (BIOCELL surface), Eurosilicone, GC Aesthetics, Silimed and others, began producing the “salt-loss” texturization either by spraying, by dipping or sprinkling fine salt crystals onto the silicone shell before curing, and supposedly removed afterwards by rinsing with water without brushing.
44
,45
This texturization was coarse and somehow different from the one created by other manufacturers as Mentor's (Siltex surface), generating a finer homogeneous outer texture by a pressure imprint-stamping technique.- Duteille F.
- Perrot P.
- Bacheley M.H.
- Bell E.
- Stewart S.
Ten-year safety data for eurosilicone's round and anatomical silicone gel breast implants.
Aesthet Surg J Open Forum. 2019; 1 (Published 2019 Apr 27): ojz012https://doi.org/10.1093/asjof/ojz012
46
,47
In this period, fear over health concerns linked to silicone, favored the development of filler alternatives as the LipoMatrix's Trilucent BIs, marketed and sold in Europe from 1995 only with pre-clinical safety data. They differed from previous generations of BIs for being filled with soybean oil, thought to be safer compared to PDMS.
48
Later evidence suggested an high early implant rupture rate,49
caused by extreme fragility of the implant's shell which deteriorated causing bleeding of the triglyceride filler, the latter linked to the formation of toxic oxidation products that caused pronounced inflammatory reaction.50
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) additionally found that the degradation of the oil was linked to cancer and birth defects. After adverse reports Trilucent BIs were voluntarily withdrawn in March 199951
and in June 2000 were recommended to be removed due to the risk of local tissue exposure to toxic compounds.52
Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). 2014. The safety of poly implant prothèse (PIP) silicone breast implants - update of the opinion of February 2012. [online] Available at: https://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_043.pdf [Accessed 29 December 2021], doi: 10.2772/66097
The Poly Implant Prothèse (PIP), French manufacturer, launched in 1991 and began producing in 1997 silicone-filled BIs which became popular for their competitive marketing strategy. After the FDA refusing to approve PIP BIs in 2000 because of deviations from good manufacturing practices, the company came under scrutiny from European regulators in March 2010 when the French Agency for the Safety of Health Products (formerly AFSSAPS, now ANSM) performed an inspection of the company's headquarters following numerous reports of early implant rupture. They found evidence of unapproved low-quality industrial-grade silicone gel used during the manufacturing process instead of medical-grade PDMS.
53
Consequently, they ordered to suspend the sale of all PIP BIs and their withdrawal from the market,54
affecting approximately 400,000 women in 65 countries55
from health risks of locoregional- K Groth A.
- Graf R.
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and the textured breast implant crisis.
Aesthet Plast Surg. 2020; 44 ([published correction appears in Aesthetic Plast Surg. 2020 Oct;44(5):1951]): 1-12https://doi.org/10.1007/s00266-019-01521-3
56
and systemic silicone spread.57
,58
It ultimately led to PIP filing for bankruptcy and to the arrest of the company's Chief Executive Officer. Germany's Technical Inspection Association (TÜV Rheinland) was among the bodies that certified PIP implants, and was found liable by French judges according to whom TÜV could not have been oblivious to the fraud.- Noone R.B.
A review of the possible health implications of silicone breast implants.
Cancer. 1997; 79: 1747-1756https://doi.org/10.1002/(sici)1097-0142(19970501)79:9<1747::aid-cncr17>3.0.co;2-y
59
Because of the seriousness of the situation and the high risk of premature rupture, in December 2011 the ANSM recommended all women with PIP BIs to preemptively remove them,BBC News. 2017. PIP breast implants: French court tells TUV to pay damages. [online] Available at: https://www.bbc.com/news/world-europe-38692678 [Accessed 6 December 2021].
60
applying the precautionary principle from the Treaty on the functioning of the European Union, Art. 191, which should be applied “when a product may have a dangerous effect, identified by a scientific and objective evaluation, if this evaluation does not allow the risk to be determined with sufficient certainty”.61
,French National Agency for the Safety of Medicines and Health Products. 2011. Update of recommendations for women with silicone filled poly implant prosthesis (PIP) breast implants. [online] Available at: https://ansm.sante.fr/uploads/2020/12/22/pip-cp-ministere-actualisation-23122011-en.pdf [Accessed 4 December 2021].
62
EUR-Lex (European Union law). 2007. Consolidated versions of the treaty on European Union and the treaty on the functioning of the European Union. [online] Available at: http://data.europa.eu/eli/treaty/tfeu_2012/oj [Accessed 6 January 2022].
Silimed, born in Rio de Janeiro in 1978, started production of BIs in 1981 including PU-coated BIs from 1989, and received the CE mark 1998. On September 2015, the German Federal Institute for Drugs and Medical Devices (BfArM) conducted an inspection of the Brazilian company's manufacturing plant, finding evidence that surfaces of textured and PU-coated implants were contaminated with man-made mineral fibers (MMMFs), potentially carcinogenic to humans. As a result of this discovery, the MHRA, jointly with European healthcare product regulators of member states, again followed the precautionary principle and ordered the suspension of CE certificate for all Silimed medical devices.
59
,BBC News. 2017. PIP breast implants: French court tells TUV to pay damages. [online] Available at: https://www.bbc.com/news/world-europe-38692678 [Accessed 6 December 2021].
65
In the same year, health authorities in the Netherlands appointed the Independent Clinical Expert Advisory Group (ICEAG) to investigate whether MMMFs found on Silimed BIs could elevate cancer risk to a level higher than the “acceptable” one.United Kingdom Government. 2015. Suspension of devices manufactured by silimed. [online] Available at: https://www.gov.uk/government/news/suspension-of-devices-manufactured-by-silimed [Accessed 5 December 2021].
66
The authors of the risk analysis warned about important uncertainties and limitations to their estimate, like the intraperitoneal introduction of fibers in the rat model used for the study, or the larger size of the fibers (median length of ∼180 µm and diameter of 9 µm) found on Silimed implants, which may lead to a lower toxicity if encapsulated or conversely to a higher toxicity due to frustrated phagocytosis and increased biopersistence. In fact, macrophages fail to incorporate and remove foreign bodies larger than >30 µm, leading to cytokines storm and chronic persistent inflammation.Venhuis B.J., Keizers P., Geertsma R., Woutersen M., Muller A., Pronk M. Dutch National Institute for Public Health and the Environment. RIVM letter report 2015-0202 - risk analysis of particulate contamination on silimed silicone-based breast implants. Published 2015. Accessed October 3, 2021. https://www.rivm.nl/bibliotheek/rapporten/2015-0202.pdf
67
Based on that analysis, the cancer risk could range from lower (0.442:1000000) to higher (9:1000000) than 1 in 1000000, and it was considered “acceptable” by EU regulatory agencies, similar to previously done by the FDA when studying PU carcinogenicity. The ICEAG concluded that being the risk “very small and around the acceptability limit”, that decisions about risk management in patients with potentially contaminated BIs should be made jointly by patients and their treating physicians. These MMMFs were not found on their smooth devices, and should not be found on any BI surface in general.63
, 64
The Australian Therapeutic Goods Administration (TGA) followed suit and canceled all Silimed devices from their register on November 2016,
68
and later Loch-Wilkinson et al.,Therapeutic Goods Administration (TGA). 2017. Silimed medical devices (all - including breast implants). [online] Available at: https://www.tga.gov.au/alert/silimed-medical-devices-all-including-breast-implants [Accessed 5 December 2021].
69
Collet et al.70
and Magnusson et al.- Collett D.J.
- Rakhorst H.
- Lennox P.
- Magnusson M.
- Cooter R.
- Deva A.K.
Current risk estimate of breast implant-associated anaplastic large cell lymphoma in textured breast implants.
Plast Reconstr Surg. 2019; 143 (3S A Review of Breast Implant–Associated Anaplastic Large Cell Lymphoma): 30S-40Shttps://doi.org/10.1097/PRS.0000000000005567
71
showed a carcinogenicity risk for Silimed PU BIs as high as 1 in 2,832 implants. Sientra, which is a US-based company that hired Silimed for manufacturing their BIs, voluntarily placed a temporary hold on the sale in the US of all Sientra devices manufactured by Silimed, advising surgeons to discontinue implanting them.72
Sientra has now severed ties with Silimed and manufactures its own BIs on American soil. Meanwhile, Silimed has addressed the health concerns and has recovered the CE mark, but Silimed products have not been sold in the EU since 2015.Sientra. 2015. Sientra sends letter to plastic surgeons regarding silimed-manufactured products. [online] Available at: https://investors.sientra.com/news/news-details/2015/Sientra-Sends-Letter-to-Plastic-Surgeons-Regarding-Silimed-Manufactured-Products/default.aspx [Accessed 5 December 2021].
73
UK's Medicines and Healthcare products Regulatory Agency. 2018. Devices made by silimed - updates from MHRA on the suspension of devices made by silimed. [online] Available at: https://www.gov.uk/government/publications/devices-made-by-silimed [Accessed 6 January 2022].
From 2010 onward, companies have attempted to introduce filler innovations such as the Diagon/Gel 4 (POLYTECH Health & Aesthetics GmbH) which combines 2 different types of silicone gel, softer on the back while firmer in the front, in a textured anatomical implant.
74
- Brunnert K.E.
The micropolyurethane foam-coated Diagon/Gel(®)4Two implant in aesthetic and reconstructive breast surgery - 3-year results of an ongoing study.
GMS Interdiscip Plast Reconstr Surg DGPW. 2015; 4 (Doc20. Published 2015 Dec 21)https://doi.org/10.3205/iprs000079
Recently, all textured 4th and 5th generations of BIs become potentially afflicted by another crisis, related to the onset of a hematological cancer named Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). First reported in 1997 by Keech and Creech,
75
it was highlighted later by the FDA alert in 2011,76
and finally recognized as a separate nosological entity by the World Health Organization in 2016.US Food and Drug Administration. 2021. FDA update on the safety of silicone gel-filled breast implants. [online] Available at: https://www.fda.gov/files/medical%20devices/published/Update-on-the-Safety-of-Silicone-Gel-Filled-Breast-Implants-%282011%29.pdf [Accessed 5 December 2021].
77
In 2017, the European Commission on Health (DG SANTE) requested the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) to provide a scientific opinion on the safety of BIs, which concluded that there were “insufficient scientific information available to establish a methodologic robust risk assessment regarding a possible association between BI and ALCL development” and recommended the scientific community to conduct a more in-depth evaluation.78
Scientific Committee on Health Environmental and Emerging Risks (SCHEER). 2017. Scientific advice on The state of scientific knowledge regarding a possible connection between breast implants and anaplastic large cell lymphoma. [online] Available at: https://ec.europa.eu/health/sites/default/files/scientific_committees/scheer/docs/scheer_o_007.pdf [Accessed 6 January 2022].
On December 14th, 2018, French notified body GMED denied the renewal of the CE mark for Allergan BIOCELL textured BIs and tissue expanders.
79
This hindered the sale of Allergan BIs across Europe, and was followed soon after by the ANSM's ban on the sale and use of macrotextured and polyurethane-coated BIs in France on April 4th, 2019, affecting several brands.80
FDA followed suit on July 24, 2019, ordering a class I voluntary recall of all Allergan textured devices from the market due to BIA-ALCL risk.81
- Singh M.
- Singh G.
- Singh Chauhan A.
- et al.
Impact of FDA updates on public interest in breast implant-associated anaplastic large cell lymphoma.
Plast Reconstr Surg Glob Open. 2020; 8 (Published 2020 Nov 23): e3240https://doi.org/10.1097/GOX.0000000000003240
In 2019, the European Commission on Health (DG SANTE) requested again the SCHEER to provide a scientific opinion on the safety of BIs.
82
Two years after the previous request it was concluded that there is a causal relationship between all textured BIs and BIA-ALCL, that not all devices give rise to the disease, and that the incidence is higher in patients with macrotextured devices according to ISO-14607:2018, being disproportionately higher with specific types or brands (Allergan Biocell, Silimed Polyurethane).- De Jong W.H.
- Panagiotakos D.
- Proykova A.
- et al.
Final opinion on the safety of breast implants in relation to anaplastic large cell lymphoma: report of the scientific committee on health, emerging and environmental risks (SCHEER).
Regul Toxicol Pharmacol. 2021; 125104982https://doi.org/10.1016/j.yrtph.2021.104982
67
,68
In addition, there is evidence to suggest that this type of ALCL is not only linked to BIs, but to implantable textured devices in general.Therapeutic Goods Administration (TGA). 2017. Silimed medical devices (all - including breast implants). [online] Available at: https://www.tga.gov.au/alert/silimed-medical-devices-all-including-breast-implants [Accessed 5 December 2021].
83
The scientific evidence for causal relationship was weighted as “moderate”, as there are sufficient scientific data from a primary line of evidence, based on a majority of epidemiological studies, that being retrospective case-control studies have limited ability for causal inference. Thus the claim for a causal relationship needs to be strengthened by a secondary etiopathogenetic line of evidence. While accounting for a possible genetic predisposition, the pathogenic mechanism of chronic inflammation leading to lymphomagenesis could be triggered by multiple, possibly combined, etiologic hypotheses such as bacterial contamination, shell shedding of particulates, shell surface characteristics leading to friction, or by implant-associated reactive compounds.
84
Nevertheless, because of the etiology gaps in the secondary line, reaching a strong weight of evidence would require randomized controlled trials on humans, which are obviously unethical and unachievable as high-risk devices have been withdrawn.85
As most authorities are not giving precise guidance, some surgeons continue using macrotextured devices that are still available on the market.European Union Scientific Committee on Health, Environmental and Emerging Risks (SCHEER). Memorandum on weight of evidence and uncertainties. Published 2018. Accessed October 22, 2021. https://ec.europa.eu/health/sites/default/files/scientific_committees/scheer/docs/scheer_o_014.pdf doi:10.2875/386011
86
,- Cardoso M.J.
- Wyld L.
- Rubio I.T.
- et al.
EUSOMA position regarding breast implant associated anaplastic large cell lymphoma (BIA-ALCL) and the use of textured implants.
Breast. 2019; 44 ([published correction appears in Breast. 2019 Dec;48:102]): 90-93https://doi.org/10.1016/j.breast.2019.01.011
87
Others have abandoned textured BIs altogether, implementing the use of smooth devices in their practice instead,88
or even evaluating the pre-emptive explantation and replacement from textured to smooth devices.- Montemurro P.
- Tay V.K.S.
Transitioning from conventional textured to nanotextured breast implants: our early experience and modifications for optimal breast augmentation outcomes.
Aesthet Surg J. 2021; 41 ([published correction appears in Aesthet Surg J. 2021 Sep 14;41(10):1221]): 189-195https://doi.org/10.1093/asj/sjaa169
89
,90
Regardless of personal beliefs, BI markets have responded to the health crisis related to texturing by progressively shifting to smooth implants in some parts of the world.91
In USA, the use of textured BIs for all placements which started at 3.4% in 2007, increased significantly and peaked at 22.89% in 2016, and then dropped again to 3.61% in 2019.Bröstimplantatregistret (BRIMP). 2019. The breast implant register annual report. [online] Available at: https://registercentrum.blob.core.windows.net/brimp/r/BRIMP-Annual-Report-2019-HJeBIdtlJP.pdf [Accessed 19 December 2021].
92
But with the exception of France, the same cannot be said for other European countries, where textured BIs still represent the majority of used devices until 2018.93
There is no doubt that previous banning, cultural and market differences have created a population of surgeons that are more comfortable using smooth implants in the USA,94
compared to their European counterpart, for whom a transition from textured shaped to round smooth devices might jeopardize esthetic outcomes,84
and might require a learning curve before achieving similar results.85
European Union Scientific Committee on Health, Environmental and Emerging Risks (SCHEER). Memorandum on weight of evidence and uncertainties. Published 2018. Accessed October 22, 2021. https://ec.europa.eu/health/sites/default/files/scientific_committees/scheer/docs/scheer_o_014.pdf doi:10.2875/386011
“Modern times” – out with the old, in with the new
Necessity is the mother of invention. Today's most feared macrotextured implant-related complications have been linked to the potential effects of chronic inflammation.
95
Studies on animal models confirm this by reporting highest amounts of inflammation and foreign body response in devices with roughness >80 µm.96
This has pushed for the creation of safer BIs with a new sixth generation, which was introduced in the early 2010s and implements evidence-based modifications that help mitigate foreign body reaction.
97
These BIs include Motiva Silk Smooth, Sebbin Integrity and Sublimity, and Nagor Perle lines. Despite a smooth outer surface according to ISO-14607:2018,98
they present peculiar biomimetic topography, different from previous smooth implants,99
,100
which aims at reducing bacterial growth and inflammatory response compared to macrotextured devices, all the while minimizing host response.101
,- Mendonça Munhoz A.
- Santanelli di Pompeo F.
- De Mezerville R.
Nanotechnology, nanosurfaces and silicone gel breast implants: current aspects.
Case Rep Plast Surg Hand Surg. 2017; 4 (Published 2017 Nov 29): 99-113https://doi.org/10.1080/23320885.2017.1407658
102
Other innovative features of new generation devices include the ergonomic and rheological filler gels which change shape and projection according to the position,103
or advanced multilayered elastomer shells to minimize silicone diffusion.- Sforza M.
- Hammond D.C.
- Botti G.
- et al.
Expert consensus on the use of a new bioengineered, cell-friendly, smooth surface breast implant.
Aesthet Surg J. 2019; 39 ([published correction appears in Aesthet Surg J. 2019 May 08;:]): S95-S102https://doi.org/10.1093/asj/sjz054
104
GC Aesthetics. 2021. Introducing impleo smooth™. [online] Available at: https://www.gcaesthetics.com/wp-content/uploads/2019/07/IMPLEO_Smooth_Visual_Aid.pdf [Accessed 5 December 2021].
Another filler innovation was introduced in 2015 as a lightweight alternative to traditional silicone, implant named B-Lite, manufactured by the Israeli company G&G Biotechnology Ltd. and owned by POLYTECH Health & Aesthetics GmbH since 2018. They are silicone-filled BIs, with smooth or textured surface, that use innovative microsphere technology to disperse inert hollow borosilicate beads throughout its filler silicone, resulting in a lighter implant for a given volume.
105
On February 2021, B-Lite received a temporary CE mark suspension due to the concern for the presence of filler gel with beads, larger than 30 µm, on the outer shell of the devices. It is unclear whether was the filler bleeding through the implant shell or touching the outer surface during manufacturing. Nevertheless, the suspension was meant to last 3 months, and eventually the CE mark was reinstated,- Govrin-Yehudain O.
- Calderon N.
- Govrin-Yehudain J.
Five year safety and satisfaction with the lightweight breast implant.
Aesthet Surg J. 2021; ([published online ahead of print, 2021 Feb 10]): sjab054https://doi.org/10.1093/asj/sjab054
106
but so far B-Lite are not yet available on the market and still have not received the FDA approval (Table 1).Table 1Silicone breast implant characteristics. Adapted from Barr et al.’s Table “Implant characteristics” (Barr S, Bayat A. Breast implant surface development: perspectives on development and manufacture. Aesthet Surg J. 2011;31(1):56–67. doi:10.1177/1,090,820 × 10,390,921).
| Type of BI | Period of Use | Outer Surface | Core | Shell |
|---|---|---|---|---|
| First Generation | 1963–1973 |
|
|
|
| Second Generation | 1972–1982 |
|
|
|
| Third Generation | 1982 onward |
|
|
|
| Fourth Generation | 1987 onward |
|
|
|
| Fifth Generation | 1993 onward |
|
|
|
| Polyurethane | 1968 onward |
|
|
|
| Double Lumen | 1976 onward |
|
|
|
| Trilucent | 1995–1999 |
|
|
|
| Poly Implant Prothèse | 1997–2010 |
|
|
|
| Diagon/Gel 4Two | 2010 onward |
|
|
|
| Sixth Generation | 2010 onward |
|
|
|
| B-Lite | 2015 onward |
|
|
|
BI, Breast implant; LMWC, Low molecular weight chain; HMWC, High molecular weight chain; PU, Polyurethane.
As of today in absence of proper obligatory or opt-out breast implants registries, it can only be approximately estimated that millions of BIs are sold and implanted, assisting plastic surgeons in their pursuit to offer solutions in difficult clinical reconstructive and esthetic cases. Most women are pleased with their implants, and those on the marked today are considered safe by regulatory authorities. Nevertheless, history teaches us that only vigorous manufacturing processes, investment in innovation, and attentive vigilance can help us maintain these devices safe and available.
On the basis of previous failures and innovations, the latest frontier for implant is 3D bioprinting technology, which uses cells and growth factors as the “ink” to create structures that resemble natural tissues such as fat and blood vessels.
107
,- Galstyan A.
- Bunker M.J.
- Lobo F.
- et al.
Applications of 3D printing in breast cancer management.
3D Print Med. 2021; 7 ([published correction appears in 3D Print Med. 2021 Jul 7;7(1):19]) (Published 2021 Feb 9): 6https://doi.org/10.1186/s41205-021-00095-8
108
The promise of these technologies has the ultimate goal of producing de novo organs for transplantation.109
The near future might also bring us the use of scaffolds that can act as standalone devices, functioning as temporary carriers for autologous tissues, where adipocytes introduced through fat transfers replace the scaffold over time.- Jovic T.H.
- Combellack E.J.
- Jessop Z.M.
- Whitaker I.S.
3D bioprinting and the future of surgery.
Front Surg. 2020; 7 (Published 2020 Nov 27)609836https://doi.org/10.3389/fsurg.2020.609836
110
Polycaprolactone has been recently found on a preclinical level as a successful biomaterial for breast tissue engineering.111
,112
In conclusion, it is only by understanding the past of BIs that we can expect to move forward with innovative designs and refinements which will ultimately benefit patients’ health and satisfy their esthetic expectations.
Ethical approval
Not required.
Declaration of Competing Interest
The Corresponding author would like to disclose that he received reimbursements for travel/lodgment expenses from ICEAG in 2015 and SCHEER-WG in 2019, 2020 and 2021, is a member of Notified Body 0373, part of the Superior Institute of Health, carrying out CE Mark certification activities for the Italian Ministry of Health for the year 2021, and Consultant for Bellaseno GmbH for the year 2021 and 2022. He has no ownerships or investments to disclose. All other authors hereby certify, that to the best of their knowledge no financial support or benefits has been received, neither by themselves directly, nor by any member of their immediate family or any individual or entity with whom or with which they may have a significant relationship from any commercial source which is related directly or indirectly to the scientific work which is reported on in the article. None of the authors has a financial interest in any of the products, devices, or drugs mentioned in this manuscript.
Funding
None.
References
International Organization for Standardization. 2018. ISO 14607:2018(en) - non-active surgical implants — mammary implants — particular requirements. [online] Available at: https://www.iso.org/obp/ui/#iso:std:iso:14607:ed-3:v2:en [Accessed 6 January 2022].
- Functional biocompatibility testing of silicone breast implants and a novel classification system based on surface roughness.J Mech Behav Biomed Mater. 2017; 5 (Nov; 7): 75-81
- Breast implant surface texture impacts host tissue response.J Mech Behav Biomed Mater. 2018; (Dec; 88): 377-385
- The functional influence of breast implant outer shell morphology on bacterial attachment and growth.Plast Reconstr Surg. 2018; 142: 837-849
- Breast implant design.Gland Surg. 2017; 6: 148-153https://doi.org/10.21037/gs.2016.11.09
- Textured silicone breast implant use in primary augmentation: core data update and review.Plast Reconstr Surg. 2015; 135: 113-124https://doi.org/10.1097/PRS.0000000000000832
- Safety of Silicone Breast Implants. 2. National Academies Press (US), Washington (DC)1999 (Silicone Chemistry. Available from: https://www.ncbi.nlm.nih.gov/books/NBK44788/)
- Breast implants: saline or silicone?.Aesthet Surg J. 2010; 30: 557-570https://doi.org/10.1177/1090820X10380401
- The evolution of breast implants.Clin Plast Surg. 2009; 36: 1-vhttps://doi.org/10.1016/j.cps.2008.08.001
- Experiences with a large series of silastic breast implants.Plast Reconstr Surg. 1972; 49: 253-258https://doi.org/10.1097/00006534-197203000-00002
- The safety and efficacy of breast implants for augmentation mammaplasty.Plast Reconstr Surg. 1984; 74: 550-560https://doi.org/10.1097/00006534-198410000-00019
- Long-term safety and efficacy of polyurethane foam-covered breast implants.Aesthet Surg J. 2006; 26: 265-274https://doi.org/10.1016/j.asj.2006.04.001
- Further studies on the natural-Y breast prosthesis.Plast Reconstr Surg. 1972; 49: 414-419https://doi.org/10.1097/00006534-197204000-00009
- Breast implant classification with MR imaging correlation: (CME available on RSNA link).Radiographics. 2000; 20: E1https://doi.org/10.1148/radiographics.20.3.g00mae11
- Breast implant surface development: perspectives on development and manufacture.Aesthet Surg J. 2011; 31: 56-67https://doi.org/10.1177/1090820X10390921
- Analysis of risk factors associated with rupture of silicone gel breast implants.Plast Reconstr Surg. 1999; 104: 955-963https://doi.org/10.1097/00006534-199909040-00009
- Current status of breast implant survival properties and the management of the woman with silicone gel breast implants.Can J Plast Surg. 2000; 8: 54-67https://doi.org/10.1177/229255030000800201
- The evolution of FDA policy on silicone breast implants: a case study of politics, bureaucracy, and business in the process of decision-making.Int J Health Serv. 1995; 25: 573-591https://doi.org/10.2190/QGG6-XCDX-F830-94AX
- Specific applications of the double lumen prosthesis.Clin Plast Surg. 1976; 3: 247-263
- Breast reconstruction using an inflatable breast implant with detachable reservoir.Plast Reconstr Surg. 1984; 73: 678-683https://doi.org/10.1097/00006534-198404000-00031
US Food and Drug Administration. 2020. Saline, silicone gel, and alternative breast implants, guidance for industry and food and drug administration staff. [online] Available at: https://www.fda.gov/media/71081/download [Accessed 5 December 2021].
- Toxic hydrolysis product from a biodegradable foam implant.J Biomed Mater Res. 1989; 23: 311-319https://doi.org/10.1002/jbm.820231406
- Measurement of 2,4-toluenediamine in urine and serum samples from women with Même or Replicon breast implants.Plast Reconstr Surg. 1997; 100: 1291-1298https://doi.org/10.1097/00006534-199710000-00035
- Water Quality: Guidelines, Standards and Health.IWA Publishing, 2001 (Accessed October 17, 2021 https://apps.who.int/iris/handle/10665/42442)
U.S. Food and Drug Administration. 2004. FDA breast implant consumer handbook 2004: timeline of breast implant activities. [online] Available at: http://www.professor-graf.de/tl_files/professor-graf/Infos/Aesthetik/fdabreastprosthesis.pdf [Accessed 19 December 2021].
- Breast implants. A review.Acta Chir Belg. 2004; 104: 158-165https://doi.org/10.1080/00015458.2004.11679528
- Polyurethane-coated breast implants revisited: a 30-year follow-up.Arch Plast Surg. 2015; 42: 186-193https://doi.org/10.5999/aps.2015.42.2.186
- Long-term safety and effectiveness of style 410 highly cohesive silicone breast implants.Aesthet Plast Surg. 2009; 33: 430-438https://doi.org/10.1007/s00266-009-9360-x
- Rupture rate and patterns of shell failure with the McGhan Style 153 double-lumen breast implant.Plast Reconstr Surg. 2011; 127: 47-53https://doi.org/10.1097/PRS.0b013e3181fad248
- Silicone breast implant litigation.Virtual Mentor. 2010; 12 (Published 2010 May 1): 389-394https://doi.org/10.1001/virtualmentor.2010.12.5.hlaw1-1005
- The basis of the FDA's decision on breast implants.N Engl J Med. 1992; 326: 1713-1715https://doi.org/10.1056/NEJM199206183262525
- The biology and evolution of cohesive gel and shaped implants.Plast Reconstr Surg. 2014; 134: 6S-11Shttps://doi.org/10.1097/PRS.0000000000000347
- Safety of Silicone Breast Implants. 3. National Academies Press (US), Washington (DC)1999 (Implant Catalogue. Available from: https://www.ncbi.nlm.nih.gov/books/NBK44794/)
- Review: the breast implant fiasco.Calif Law Rev. 1999; 87: 457-510
- Breast augmentation: a risk factor for breast cancer?.N Engl J Med. 1992; 326: 1649-1653https://doi.org/10.1056/NEJM199206183262501
- Risk of connective-tissue diseases and other disorders after breast implantation.N Engl J Med. 1994; 330: 1697-1702https://doi.org/10.1056/NEJM199406163302401
- Silicone breast implants and the risk of connective-tissue diseases and symptoms.N Engl J Med. 1995; 332: 1666-1670https://doi.org/10.1056/NEJM199506223322502
- Silicone breast implants and the risk of autoimmune/rheumatic disorders: a real-world analysis.Int J Epidemiol. 2018; 47: 1846-1854https://doi.org/10.1093/ije/dyy217
- US FDA breast implant postapproval studies: long-term outcomes in 99,993 patients.Ann Surg. 2019; 269: 30-36https://doi.org/10.1097/SLA.0000000000002990
- Safety and effectiveness of mentor's MemoryGel implants at 6 years.Aesthet Plast Surg. 2009; 33 ([published correction appears in Aesthetic Plast Surg. 2009 May;33(3):439]): 440-444https://doi.org/10.1007/s00266-009-9364-6
- Inamed silicone breast implant core study results at 6 years.Plast Reconstr Surg. 2007; 120: 8S-16Shttps://doi.org/10.1097/01.prs.0000286580.93214.df
- Physical properties of silicone gel breast implants.Aesthet Surg J. 2019; 39 ([published correction appears in Aesthet Surg J. 2019 Nov 13;39(12):NP552-NP553]): 264-275https://doi.org/10.1093/asj/sjy103
- Introduction to "management of patients with textured implants".Plast Reconstr Surg. 2021; 147: 5S-6Shttps://doi.org/10.1097/PRS.0000000000008038
- Breast implant surface texture impacts host tissue response.J Mech Behav Biomed Mater. 2018; 88: 377-385https://doi.org/10.1016/j.jmbbm.2018.08.035
- Ten-year safety data for eurosilicone's round and anatomical silicone gel breast implants.Aesthet Surg J Open Forum. 2019; 1 (Published 2019 Apr 27): ojz012https://doi.org/10.1093/asjof/ojz012
- A review of the use of silicone implants in breast surgery.Expert Rev Med Devices. 2016; 13: 143-156https://doi.org/10.1586/17434440.2016.1134310
- The history and development of breast implants.Ann R Coll Surg Engl. 2020; 102: 478-482https://doi.org/10.1308/rcsann.2020.0003
- Public health implications of differences in U.S. and European Union regulatory policies for breast implants.Reprod Health Matters. 2012; 20: 102-111https://doi.org/10.1016/S0968-8080(12)40662-0
- Trilucent breast implants: a 3 year series.Br J Plast Surg. 2001; 54: 125-127https://doi.org/10.1054/bjps.2000.3490
- What exactly was wrong with the Trilucent breast implants? A unifying hypothesis.Plast Reconstr Surg. 2004; 113: 847-856https://doi.org/10.1097/01.prs.0000105337.12656.dc
- Breast augmentation: part I–A review of the silicone prosthesis.J Plast Reconstr Aesthet Surg. 2010; 63: 1761-1768https://doi.org/10.1016/j.bjps.2009.07.047
Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). 2014. The safety of poly implant prothèse (PIP) silicone breast implants - update of the opinion of February 2012. [online] Available at: https://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_043.pdf [Accessed 29 December 2021], doi: 10.2772/66097
- Silicone breast implant materials.Swiss Med Wkly. 2012; 142 (Published 2012 Jul 23): w13614https://doi.org/10.4414/smw.2012.13614
- The ``PIP scandal'' - complications in breast implants of inferior quality: state of knowledge, official recommendations and case report.Geburtshilfe Frauenheilkd. 2012; 72: 243-246https://doi.org/10.1055/s-0031-1298323
- Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and the textured breast implant crisis.Aesthet Plast Surg. 2020; 44 ([published correction appears in Aesthetic Plast Surg. 2020 Oct;44(5):1951]): 1-12https://doi.org/10.1007/s00266-019-01521-3
- Locoregional silicone spread after high cohesive gel silicone implant rupture.J Plast Reconstr Aesthet Surg. 2006; 59: 885-886https://doi.org/10.1016/j.bjps.2005.12.014
- Demonstration of silicon in sites of connective-tissue disease in patients with silicone-gel breast implants.Arch Dermatol. 1993; 129: 63-68
- A review of the possible health implications of silicone breast implants.Cancer. 1997; 79: 1747-1756https://doi.org/10.1002/(sici)1097-0142(19970501)79:9<1747::aid-cncr17>3.0.co;2-y
BBC News. 2017. PIP breast implants: French court tells TUV to pay damages. [online] Available at: https://www.bbc.com/news/world-europe-38692678 [Accessed 6 December 2021].
- The PIP scandal: an analysis of the process of quality control that failed to safeguard women from the health risks.J R Soc Med. 2013; 106: 173-177https://doi.org/10.1177/0141076813480994
French National Agency for the Safety of Medicines and Health Products. 2011. Update of recommendations for women with silicone filled poly implant prosthesis (PIP) breast implants. [online] Available at: https://ansm.sante.fr/uploads/2020/12/22/pip-cp-ministere-actualisation-23122011-en.pdf [Accessed 4 December 2021].
EUR-Lex (European Union law). 2007. Consolidated versions of the treaty on European Union and the treaty on the functioning of the European Union. [online] Available at: http://data.europa.eu/eli/treaty/tfeu_2012/oj [Accessed 6 January 2022].
- Man-made mineral (vitreous) fibres: evaluations of cancer hazards by the IARC monographs programme.Mutat Res. 2004; 553: 43-58https://doi.org/10.1016/j.mrfmmm.2004.06.019
- Synthetic vitreous fibers: a review toxicology, epidemiology and regulations.Crit Rev Toxicol. 2007; 37: 839-886https://doi.org/10.1080/10408440701524592
United Kingdom Government. 2015. Suspension of devices manufactured by silimed. [online] Available at: https://www.gov.uk/government/news/suspension-of-devices-manufactured-by-silimed [Accessed 5 December 2021].
Venhuis B.J., Keizers P., Geertsma R., Woutersen M., Muller A., Pronk M. Dutch National Institute for Public Health and the Environment. RIVM letter report 2015-0202 - risk analysis of particulate contamination on silimed silicone-based breast implants. Published 2015. Accessed October 3, 2021. https://www.rivm.nl/bibliotheek/rapporten/2015-0202.pdf
- The macrophage capacity for phagocytosis.J Cell Sci. 1992; 101: 907-913
Therapeutic Goods Administration (TGA). 2017. Silimed medical devices (all - including breast implants). [online] Available at: https://www.tga.gov.au/alert/silimed-medical-devices-all-including-breast-implants [Accessed 5 December 2021].
- Breast implant-associated anaplastic large cell lymphoma in Australia and New Zealand: high-surface-area textured implants are associated with increased risk.Plast Reconstr Surg. 2017; 140: 645-654https://doi.org/10.1097/PRS.0000000000003654
- Current risk estimate of breast implant-associated anaplastic large cell lymphoma in textured breast implants.Plast Reconstr Surg. 2019; 143 (3S A Review of Breast Implant–Associated Anaplastic Large Cell Lymphoma): 30S-40Shttps://doi.org/10.1097/PRS.0000000000005567
- The epidemiology of breast implant-associated anaplastic large cell lymphoma in Australia and New Zealand confirms the highest risk for grade 4 surface breast implants.Plast Reconstr Surg. 2019; 143: 1285-1292https://doi.org/10.1097/PRS.0000000000005500
Sientra. 2015. Sientra sends letter to plastic surgeons regarding silimed-manufactured products. [online] Available at: https://investors.sientra.com/news/news-details/2015/Sientra-Sends-Letter-to-Plastic-Surgeons-Regarding-Silimed-Manufactured-Products/default.aspx [Accessed 5 December 2021].
UK's Medicines and Healthcare products Regulatory Agency. 2018. Devices made by silimed - updates from MHRA on the suspension of devices made by silimed. [online] Available at: https://www.gov.uk/government/publications/devices-made-by-silimed [Accessed 6 January 2022].
- The micropolyurethane foam-coated Diagon/Gel(®)4Two implant in aesthetic and reconstructive breast surgery - 3-year results of an ongoing study.GMS Interdiscip Plast Reconstr Surg DGPW. 2015; 4 (Doc20. Published 2015 Dec 21)https://doi.org/10.3205/iprs000079
- Anaplastic T-cell lymphoma in proximity to a saline-filled breast implant.Plast Reconstr Surg. 1997; 100: 554-555https://doi.org/10.1097/00006534-199708000-00065
US Food and Drug Administration. 2021. FDA update on the safety of silicone gel-filled breast implants. [online] Available at: https://www.fda.gov/files/medical%20devices/published/Update-on-the-Safety-of-Silicone-Gel-Filled-Breast-Implants-%282011%29.pdf [Accessed 5 December 2021].
- The 2016 revision of the World Health Organization classification of lymphoid neoplasms.Blood. 2016; 127: 2375-2390https://doi.org/10.1182/blood-2016-01-643569
Scientific Committee on Health Environmental and Emerging Risks (SCHEER). 2017. Scientific advice on The state of scientific knowledge regarding a possible connection between breast implants and anaplastic large cell lymphoma. [online] Available at: https://ec.europa.eu/health/sites/default/files/scientific_committees/scheer/docs/scheer_o_007.pdf [Accessed 6 January 2022].
- European Association of Plastic Surgeons (EURAPS) Committee on device safety and development. breast implant-associated anaplastic large cell lymphoma (BIA-ALCL): review of epidemiology and prevalence assessment in Europe.Aesthet Surg J. 2021; 41: 1014-1025https://doi.org/10.1093/asj/sjaa285
- Breast implant-associated anaplastic large cell lymphoma: proposal for a monitoring protocol.Plast Reconstr Surg. 2015; 136: 144e-151ehttps://doi.org/10.1097/PRS.0000000000001416
- Impact of FDA updates on public interest in breast implant-associated anaplastic large cell lymphoma.Plast Reconstr Surg Glob Open. 2020; 8 (Published 2020 Nov 23): e3240https://doi.org/10.1097/GOX.0000000000003240
- Final opinion on the safety of breast implants in relation to anaplastic large cell lymphoma: report of the scientific committee on health, emerging and environmental risks (SCHEER).Regul Toxicol Pharmacol. 2021; 125104982https://doi.org/10.1016/j.yrtph.2021.104982
- From breast implant to rough implant associated-ALCL (RIA-ALCL).Aesthet Surg J. 2022; : sjac005https://doi.org/10.1093/asj/sjac005
- Cell of origin and immunologic events in the pathogenesis of breast implant-associated anaplastic large-cell lymphoma.Am J Pathol. 2020; 190: 2-10https://doi.org/10.1016/j.ajpath.2019.09.005
European Union Scientific Committee on Health, Environmental and Emerging Risks (SCHEER). Memorandum on weight of evidence and uncertainties. Published 2018. Accessed October 22, 2021. https://ec.europa.eu/health/sites/default/files/scientific_committees/scheer/docs/scheer_o_014.pdf doi:10.2875/386011
- EUSOMA position regarding breast implant associated anaplastic large cell lymphoma (BIA-ALCL) and the use of textured implants.Breast. 2019; 44 ([published correction appears in Breast. 2019 Dec;48:102]): 90-93https://doi.org/10.1016/j.breast.2019.01.011
- The use of anatomic implants in aesthetic breast surgery.Clin Plast Surg. 2021; 48: 141-156https://doi.org/10.1016/j.cps.2020.09.010
- Transitioning from conventional textured to nanotextured breast implants: our early experience and modifications for optimal breast augmentation outcomes.Aesthet Surg J. 2021; 41 ([published correction appears in Aesthet Surg J. 2021 Sep 14;41(10):1221]): 189-195https://doi.org/10.1093/asj/sjaa169
- A prospective approach to inform and treat 1340 patients at risk for BIA-ALCL.Plast Reconstr Surg. 2019; 144: 46-54https://doi.org/10.1097/PRS.0000000000005703
- Elective implant removal and replacement in asymptomatic aesthetic patients with textured devices.Plast Reconstr Surg. 2021; 147: 14S-23Shttps://doi.org/10.1097/PRS.0000000000008041
Bröstimplantatregistret (BRIMP). 2019. The breast implant register annual report. [online] Available at: https://registercentrum.blob.core.windows.net/brimp/r/BRIMP-Annual-Report-2019-HJeBIdtlJP.pdf [Accessed 19 December 2021].
- Textured and smooth implant use reported in the tracking operations and outcomes for plastic surgeons database: epidemiologic implications for BIA-ALCL.Plast Reconstr Surg Glob Open. 2021; 9: e3499https://doi.org/10.1097/GOX.0000000000003499
- Current trends in breast augmentation: an international analysis.Aesthet Surg J. 2018; 38: 133-148https://doi.org/10.1093/asj/sjx104
- Long-term safety of textured and smooth breast implants.Aesthet Surg J. 2017; 38 (Dec 13PMID: 29040370): 38-48https://doi.org/10.1093/asj/sjx157
- The state of the art about etiopathogenetic models on breast implant associated-anaplastic large cell lymphoma (BIA-ALCL): a narrative review.J Clin Med. 2021; 10 (Published 2021 May 12): 2082https://doi.org/10.3390/jcm10102082
- The surface topography of silicone breast implants mediates the foreign body response in mice, rabbits and humans.Nat Biomed Eng. 2021; 5: 1115-1130https://doi.org/10.1038/s41551-021-00739-4
- Silicone breast implant modification review: overcoming capsular contracture.Biomater Res. 2018; 22 (Published 2018 Dec 20): 37https://doi.org/10.1186/s40824-018-0147-5
- A different perspective on breast implant surface texturization and anaplastic large cell lymphoma (ALCL).Aesthet Surg J. 2019; 39: 56-63https://doi.org/10.1093/asj/sjy091
- Patterning of novel breast implant surfaces by enhancing silicone biocompatibility, using biomimetic topographies.Eplasty. 2010; 10 (Published 2010 Apr 26): e31
- Development, fabrication and evaluation of a novel biomimetic human breast tissue derived breast implant surface.Acta Biomater. 2017; 49: 260-271https://doi.org/10.1016/j.actbio.2016.11.052
- Nanotechnology, nanosurfaces and silicone gel breast implants: current aspects.Case Rep Plast Surg Hand Surg. 2017; 4 (Published 2017 Nov 29): 99-113https://doi.org/10.1080/23320885.2017.1407658
- Development and functional evaluation of biomimetic silicone surfaces with hierarchical micro/nano-topographical features demonstrates favourable in vitro foreign body response of breast-derived fibroblasts.Biomaterials. 2015; 52: 88-102https://doi.org/10.1016/j.biomaterials.2015.02.003
- Expert consensus on the use of a new bioengineered, cell-friendly, smooth surface breast implant.Aesthet Surg J. 2019; 39 ([published correction appears in Aesthet Surg J. 2019 May 08;:]): S95-S102https://doi.org/10.1093/asj/sjz054
GC Aesthetics. 2021. Introducing impleo smooth™. [online] Available at: https://www.gcaesthetics.com/wp-content/uploads/2019/07/IMPLEO_Smooth_Visual_Aid.pdf [Accessed 5 December 2021].
- Five year safety and satisfaction with the lightweight breast implant.Aesthet Surg J. 2021; ([published online ahead of print, 2021 Feb 10]): sjab054https://doi.org/10.1093/asj/sjab054
- ALCL - France update.in: Proceedings of the 3rd World Consensus Conference on BIA-ALCL. 2021 ([online] Available at:)
- Applications of 3D printing in breast cancer management.3D Print Med. 2021; 7 ([published correction appears in 3D Print Med. 2021 Jul 7;7(1):19]) (Published 2021 Feb 9): 6https://doi.org/10.1186/s41205-021-00095-8
- 3D printing breast tissue models: a review of past work and directions for future work.Micromachines. 2019; 10 (Basel)Published 2019 Jul 27: 501https://doi.org/10.3390/mi10080501
- 3D bioprinting and the future of surgery.Front Surg. 2020; 7 (Published 2020 Nov 27)609836https://doi.org/10.3389/fsurg.2020.609836
- The return of a forgotten polymer. Polycaprolactone in the 21st century.Prog Polym Sci. 2010; 35: 1217-1256https://doi.org/10.1016/j.progpolymsci.2010.04.002
- Evaluation of polycaprolactone − poly-D,L-lactide copolymer as biomaterial for breast tissue engineering.Polym Int. 2017; 66: 77-84https://doi.org/10.1002/pi.5181
- Sustained regeneration of high-volume adipose tissue for breast reconstruction using computer aided design and biomanufacturing.Biomaterials. 2015; 52: 551-560https://doi.org/10.1016/j.biomaterials.2015.01.025
Article info
Publication history
Published online: March 10, 2022
Accepted:
February 27,
2022
Received:
January 20,
2022
Identification
Copyright
© 2022 The Author(s). Published by Elsevier Ltd on behalf of British Association of Plastic, Reconstructive and Aesthetic Surgeons.
User license
Creative Commons Attribution – NonCommercial – NoDerivs (CC BY-NC-ND 4.0) | How you can reuse 
Elsevier's open access license policy
Creative Commons Attribution – NonCommercial – NoDerivs (CC BY-NC-ND 4.0)
Permitted
For non-commercial purposes:
- Read, print & download
- Redistribute or republish the final article
- Text & data mine
- Translate the article (private use only, not for distribution)
- Reuse portions or extracts from the article in other works
Not Permitted
- Sell or re-use for commercial purposes
- Distribute translations or adaptations of the article
Elsevier's open access license policy
