Key words
implant-based breast reconstruction - synthetic meshes - titanised polypropylene mesh
TiLoop
®Bra and TiLoop
®Bra-Pocket - prepectoral implant
Schlüsselworter
implantatbasierte Brustrekonstruktion - Synthetische Netze - titanisierte Polypropylene-Netze
TiLoop
®Bra und Tiloop
®Bra-Pocket - präpektorale Implantateinlage
Introduction
Throughout the year, many current aspects of plastic-reconstructive breast surgery
have been discussed in a wide range of lectures and debates in various symposia on
senology and surgery. Standards have been defined, perspectives offered, and the field
has been opened up to possible further developments.
Detailed positions have been taken on:
-
Indications
-
Patient selection
-
Anatomically correct surgical techniques with the use of intraoperative sonography
to ensure surgical precision
-
Complications and the possibility of avoiding or minimising them, as well as problem-solving
alternatives
-
Classification of surgical techniques
-
National study data.
When considering the developments in implant-based reconstructive breast surgery of
recent years, the following should be noted:
-
Changes in basic oncological techniques, from radical to skin- and nipple-saving mastectomy
techniques
-
Highly-developed cooperation between professionals (senology, surgery, plastic surgery)
in multi-disciplinary teams
-
An increase in bilateral interventions, both primary and secondary prophylactic interventions
-
An increase in reconstructive interventions in every age group, with an above-average
increase in young women
-
An increase in the number of implant-based, reconstructive interventions overall
-
Widespread and safe use of autologous reconstruction techniques
-
The introduction of newly-developed breast implants for reconstructive breast surgery
-
The introduction of materials to bridge, substitute or support the tissues in reconstructive
breast surgery since around 2008
-
Further developments in materials to bridge, substitute or support the tissues, implemented
in the German Working Group for Gynaecological Oncology’s treatment recommendations
since 2011
-
The introduction of minimally invasive surgical techniques
-
Additional tools for intraoperative safeguarding of skin perfusion
Implant-based plastic-reconstructive breast surgery
Implant-based techniques constitute approximately 40 – 60 % of all breast reconstructions
in Europe and approximately 75 % in the USA [2]
[3]
[4]. It is therefore not surprising that implant-based breast surgery modifications
of implant-based reconstructions is a subject of discussion in interdisciplinary knowledge
exchange. The performance of a subcutaneous mastectomy within anatomical limits [5]
[6]
[7] and the optimal design of the implant bed have been specified. In this context,
the surgical separation plane of the pectoralis major muscle, which is used for the
cranial covering of the implant, has also been defined [8]
[9]
[10].
Subpectoral implant placement was the previous standard method of implant-based reconstruction,
either with
-
exclusive skin coverage (mostly as an interim solution until the definitive reconstruction
is specified)
-
complete muscle coverage
-
dual-plane method with a de-epithelised corial flap
-
caudo-lateral interponation of an acellular matrix
-
caudo-lateral interponation of a synthetic mesh
-
combination techniques.
Complication types and rates are described in many analyses, although these are mainly retrospective [11]
[12]. The few prospective studies largely support the findings of the retrospective analyses.
To summarise: it can be said that the use of both synthetic meshes and of acellular
dermal and tissue matrices can be considered safe [1]
[13]
[14]
[15]. The use of synthetic meshes seems to have few complications with regard to seroma
formation and implant loss [10]. A single prospective, directly comparative study has shown that titanised polypropylene
mesh (Tiloop® Bra) has an advantage over the porcine acellular dermal matrix Strattice™ regarding
both the complication rate and the aesthetic result [16]. Newly-developed dermal matrices display a low rate of side effects in first application
and will be analysed further in studies and registries.
Besides the question of the optimum material, the question of paramount importance
regarding the implant bed is: pre- or sub-pectoral?
A large number of sometimes significant problems are caused by what is regarded as
the standard placement of the subpectoral implant ([Fig. 1]):
Fig. 1 A 34-year-old patient, 7 months post subcutaneous mastectomy (status post primary
chemotherapy, status post radiotherapy). Immediate reconstruction using subpectoral
implant placement with caudal mesh interponation. Currently with grade III capsular
contracture, implant cranialisation and empty volume in the caudal quadrants.
-
unnatural breast shapes to some extent
-
the “jumping breast” phenomenon
-
muscle response even with less expansive movements
-
muscle pain
-
contraction of the upper exterior of the severed pectoralis major muscle with wrinkle
formation below the muscle origin.
-
fasciculations
-
restricted shoulder-arm mobility.
It must be considered, however, that in the past, a prepectoral implant placement
exclusively covered by remaining skin led to changes in the subpectoral implant placement
due to the high rate of complications. Current data shows the limitations of prepectorally
placed implants, which presuppose per se a very thick layer of subcutaneous fat that
must be considered critical from the oncological perspective [17]. However, Sigalove et al. [18] report that over 207 patients have been operated on since 2008, all for prepectoral
implant placements, ADM covering and lipofilling (“bio-engineered breast concept”)
in 353 operations. The complication rate is remarkably low; infections occurred in
4.5 % of cases, seromas in only 2 % and flap necroses in 2.5 %. The authors explain
that the contraindications to a prepectoral implant placement arise with thin, poorly
perfused or ischaemic skin, in response to previous radiotherapy in conjunction with
a scar in the lower pole or in the region of the radiation boost, with a BMI of > 40,
in immunosuppressed patients, with HBA1c > 7.5 %, due to nicotine abuse or too little
fat tissue for subsequent lipofilling. In the opinion of the authors, and from the
oncological viewpoint, contraindications include breast carcinomas of > 5 cm, advanced
or deep-lying breast carcinomas, breast wall infiltration, extensive nodal involvement
and a high risk of local relapse. However, the discussion also contains a critical
assessment of whether the oncologically determined contraindications are based on
assumptions. From our perspective, these restrictions do not exist.
Thus, in our experience, the prepectoral mesh-supported implant placement increases
continuously, after initial considerations and surgery. This is partly due to a learning
curve now having been completed and the related increase in the reliability of patient
selection; another reason is that aesthetic deficits such as the development of volume
defects and dents, and the visibility of the cranial implant edge due to the increased
use of lipofilling, can now be compensated for. Thus, in our view, an important counter-argument
against prepectoral implant placement no longer categorically applies. The publication
of cases, case series and retrospective analyses shows that the prepectoral implant
bed has also increasingly been used in German-speaking countries for several years
[19]
[20]. At this year’s German Senology Society Conference, R. Reitsamer et al. presented
in a free lecture a surgical procedure that included the formation of a complete implant
sheath from an ADM, more specifically from the porcine ADM Strattice® – a procedure which is likely to be problematic from the perspective of health economics.
Preference is often given to ADMs when considering prepectoral implant placements,
as the benefit of tissue substitution is ascribed to them, resulting in better coverage
of the cranial parts of the breast. Meanwhile, different manufacturers have responded
to the special requirements of prepectoral implant placement by developing new forms
using known materials. Pre-formed ADM materials such as Braxton (DecomedSrl, Italy)
[21] can be used directly as implant pockets and other ADMs such as Tutomesh or Strattice
and Artia can be used to shape the contours. Other ADMs, to the best of our knowledge,
are not shaped but are squarer. H. Becker et al. [22] use both different synthetic meshes and ADMs to cover the implant completely in
a prepectoral implant placement.
The authors of this discussion contribution also use synthetic meshes to cover prepectorally
positioned implants just as frequently as ADMs and tissue matrices [23]. Similarly, some patients with epipectoral implant placement and Tiloop® Bra coverage were included and evaluated in the PRO Bra-Trial [24]
[25]. Observations of possible complications and problems also arise from this experience
in individual cases. New materials are also being developed in the field of synthetic
meshes. Building on the experience of D. Casella et al. [26] and M. Rezai, a titanised polypropylene implant pocket was developed, considerably
simplifying prepectoral implant placement with a full covering of titanium mesh ([Fig. 2], [3]).
Fig. 2 Synthetic mesh specially designed for prepectoral implant placement (TiLoop® Bra Pocket) Source: pfm medical AG, Cologne.
Fig. 3 A schematic drawing of the implant sheath through the synthetic mesh (blue). The
mesh covers the whole of the front surface and approx. half of the rear surface of
the implant. The mesh is sutured in the cranial mesh sections with soft tissue over,
or to the pectoral fascia. Source: pfm medical AG, Cologne.
Three different implant pockets are available, enabling incremental implant volumes
of < 270, < 420 and < 550 cm³ and implant widths from 11.0 to 15.0 cm with projections
of < 4.5 to < 6.0 cm. In addition to the already frequent use of the Tiloop® Bra pocket in Italy, different breast centres across Germany have used it on approximately
60 occasions ([Fig. 4]).
Fig. 4 A 31-year-old patient with TNBС, BRCA-1 positive, status post primary chemotherapy
in complete remission according to imaging. Preoperatively, and on the 10th day postoperatively,
post bilateral subcutaneous mastectomy, right SLNB with immediate reconstruction by
prepectoral implant placement. The augmentative aspect was desired.
To summarise the considerations regarding the individual decision for a prepectoral
implant placement from the authors’ point of view, the following factors present themselves:
from the patient’s perspective, her own wishes are naturally paramount. More objective
characteristics may be found, on the one hand, in a physically active, non-smoking
patient with a BMI of < 35, firm or slightly sagging skin with no striae distensae
or current long-term systemic cortisone treatment, with mild or moderate ptosis and
a resection weight of under 500 g. On the other hand, patients with glandular bodies
in subinvolution and very flat cleavage that a submuscular implant placement would
reconstruct in too accentuated a fashion may also benefit from prepectoral implant
placement [27]
[28]
[29]
[30]
[31]
[32]. Intraoperative decision criteria would be good skin thickness with subcutaneous
fat folds guaranteeing a good implant coverage in all quadrants, meaning that the
risk of later dents or defects can be assumed to be low, and unrestricted skin perfusion.
These criteria are admittedly rather soft and do not allow any clear preference. It
therefore remains a question of experience in conjunction with the individual learning
curve that will guide the consultation with the patient.
Concluding remarks
When reviewing the current developments in reconstructive breast surgery, it is striking
that the basic strategies have been or are covered by retrospective analyses and an
increasing number of prospective studies and data from registers, and are reflected
in the respective evidence level of the German Working Group for Gynaecological Oncology’s
treatment recommendations. This provides a high degree of user safety. Patient satisfaction
regarding the cosmetic result reaches 80 – 90 % and the complications rate is absolutely
acceptable. Nevertheless, the optimisation of autologous and implant-based reconstructive
surgical techniques must remain the focus. The consideration of which implant bed
is to be preferred in the context of individual surgery planning will be rendered
much simpler by the introduction of advanced materials. Indications and complications
should be recorded in the registers.
