International patent

One-step breast reconstruction with

Pectoralis Major intact

Muscle sparing one-step reconstruction

The simpler the better
Braxon® is the result of the experience
which has developed in the field of
tissue bio-engineering joined with that
of clinical practice aiming to create a
more conservative surgical procedure.

The study of the biomaterial’s

regenerative capacity applied
together with the constantly
ambitious challenges in the field of
reconstructive surgery has led to the
emergence in 2012 of an innovative
surgical technique which signaled a
further enhancement in the field of
one-step breast reconstruction.

Braxon® is a synthesis The one-step breast reconstruction,

when indicated, has highlighted
between the most important benefits for the patient,
who recovers her physical integrity
advanced biomaterial and in a single operation, together with
the most conservative significant cost savings for the health
economy.
anatomical impact for the
patient. Innovations in the field of biomaterial
have contributed in a major way
to enabling this new operation to
substantially improve the cosmetic
outcomes of immediate breast
reconstruction.
 Muscle
sparing why
The disinsertion of pectoralis results in a deficit of muscle function of arm flexion,
internal rotation and adduction. Over time the interference in the synergy of the
various muscle groups may result in weakness of humeral-scapular articulation
with repercussions in movement, pain and also an impaired cosmetic result.

The creation of a sub-muscular pocket for the normal procedures, one-step or

two-stage breast reconstruction is longer and more complicated and requires
postoperative physiotherapy.

The disinsertion of the

muscle causes bleeding,
postoperative pain and
seroma.
The most physiological
Implant
 Braxon®
who
More than 40 scientific studies demonstrate the safety and efficacy of Braxon®
prepectoral breast reconstruction. Our specialists are always available to inform
you about the inclusion/exclusion criteria and surgical details.

Above
muscular
pocket how
Recent publications have shown a lower ratio of capsular contractions if the
breast prosthesis is wrapped in a biological matrix.
Braxon® is a pre-shaped porcine dermis which allows the tailoring of an ADM
pocket around the mammary prosthesis and its fixing above the pectoralis
muscle, which is kept intact.
Covered by several patents, the Braxon® shape perfectly matches the contours
of a silicone prosthesis.

Braxon®
when
In one-step reconstruction after nipple or skin sparing mastectomy. When there
is a good vascularised sub-cutaneous layer.
Previous radiotherapy or co-existing medical conditions such as diabetes
or connective tissue diseases are contra-indications. The use of monopolar
diathermy in the mastectomy skin flap dissection should be reduced to a
minimum to prevent skin flap necrosis.
Technical characteristics
Braxon® is a 0.6 mm thick Acellular
Dermal Matrix (*) derived from
Synthetic meshes, made of polymers
obtained by chemical synthesis
Nowadays the concept
selected porcine dermis. It is (Polypropylene with metal coatings of biocompatibility
specifically designed for fast for example), are chemically
integration without amplifying the and physically tolerated by the isn’t enough to define
inflammatory process. organism but they do not stimulate a the effectiveness
regenerative process.
The exclusive production process In order to allow Braxon® to be of a biomaterial. Its
has been developed with the aim
of generating a completely natural
incorporated into the tissues without
an amplified inflammatory response,
performance must surpass
product (not crossed linked) without the production process entails the passive tolerance. It must
the presence of any chemical sublimation (freeze drying ) in the final
substance which can amplify the phases of the newly created acellular be active, not solely
inflammatory response and slow the graft, which allows the complete inert, with the aim of
pathway of tissue regeneration. The removal of the liquid chemicals used
native proteic structure provides the in its preparation through exact use powering the biological
benefit of immediate bio-availability
for incorporation into the host tissue
of pressure and temperature. This
process makes the product dry,
process of guided tissue
with lower inflammatory responses optimal for correct conservation at regeneration.
such as seroma or the red-skin flare room temperature, and only requires
phenomenon seen following the a simple rehydration before use, Postoperative management
implantation of other biomaterials without the need for repeat washings Early and prolonged use of a
used in breast reconstruction. to attempt the removal of damaging conforming bra for 3 or 4 weeks as well
chemicals which other products as a compressive dressing and reduced
Natural, artificial and synthetic require. mobility of the arm will significantly
matrices. decrease the seroma formation.
The natural Braxon® matrix is made Its patented shape allows a perfect fit
of native proteic polymers derived around the silicone prosthesis which (*) Acellular Dermal Matrix:
from acellularized porcine dermis creates a smooth surface with no graft A complex network of extracellular
(collagen). The organism recognises over-lap after simple suturing to the macromolecules that, in addition
it as its own, and transforms it muscle surface. It fits neatly under the to performing a cementing function
into self tissue through the natural skin in a perfect position, checked by between cells and tissues, provides an
regenerative process (remodelling). the elevation of the patient prior to organized structure in which the cells
closing the skin wound. can migrate and interact with each
Artificial meshes derive from natural other.
polymers, but they are chemically Implantation technique
modified for reinforcement (e.g.. Braxon® must be sutured to the
Cross-linked meshes). They are pectoralis major with single stitches to
tolerated by the organism but do not ensure primary stability of the matrix
stimulate any regenerative process. which requires intimate contact with
vascularized tissue.
THE WINNING IDEA
Natural
The most Aesthetics
physiological
Implant
Long-term
Follow-up
No Capsule
Contraction No
Pain
Less
Complications

Case of breast implant size

revision: in this occasion a well-
vascularized neo-fascia was
observed after 7 months from
the Braxon® procedure.
Surgical Steps

During mastectomy surgeon begins Braxon® must be hydrated for 5 Use of sizer to choice the right size and
Braxon® procedure minutes to make it soft and pliable shape of the breast implant

start

00′ 05′ 15 ′

Tailoring Braxon®
Braxon® is pre-
shaped in such a
way as to contain
a breast implant
of any size and
shape. Its use
is intuitive and
requires scissors
and suture to
“dress” the
prosthesis and be
sutured over the
pectoralis major
muscle.
Surgeon performs Braxon® tailoring Braxon® is inserted and sutured above Skin closure
around mammary prosthesis the pectoralis major

finish

35′ 45′ 60′

Questions & Answers
Is Braxon® supplied already shaped? How many drains and for how long?
Yes – It is supplied pre-shaped to wrap The inflammatory response to the
around different sizes of mammary new Braxon® chemical-free ADM
prosthesis. is much less, and as a result our
experience has shown the drains can
How is the Braxon® customized be safely removed within a few days,
to fit precisely around the chosen and certainly less than the 2 weeks
implant? necessary when alternative products
The surgeon adjusts the pre-shaped are used.
Braxon® on a sterile work surface as
shown in the brochure. What about capsular contraction
and cosmesis?
Can I use different implant sizes and To date, with long-term follow-up
shapes? there has been no clinical evidence of
Yes the pre-shaped Braxon® is capsular contraction around the sub-
adjusted to fit around any shape or cutaneous placement of the Braxon®-
sized implant. wrapped implant.

What sutures should I use? Do I need to consider using a round

Absorbable 3/0 suture, single stiches. implant to avoid the risk of rotation
often seen in sub-muscular implant
How to suture? reconstruction?
Once the tailored customized ADM No, since the Braxon®-wrapped
has been sutured in place around implant is on top rather than
the chosen implant, the superior and underneath the muscle, it is not
upper medial and lateral edges are subjected to the rotational forces of
sutured onto the pectoralis muscle muscular contraction, and also looks
having elevated the patients upper more natural when a shaped implant
body to check symmetry with the is employed. Nevertheless Braxon®
opposite breast. can perfectly “dress” also a round
implant, with same good cosmetic
results.

Braxon® bilateral implantation with

anatomical implants 15 months
postoperative photographs
References

BRX06S
ADM Braxon® pre-shaped for
total coverage of the breast
implant.

Histologies

I. II. III.

I. Hematoxylin-eosin staining of the rapid permeation of the blood following sample implants Braxon® 4 weeks
sample implants Braxon® sterile, non- implantation. following implantation. 5X magnification.
implanted. 10x magnification. The staining II. Azan-Mallory staining of sample Braxon® The hematoxylin colours in violet cellular
reveals the complete absence of cellular sterile prosthesis. 5X magnification. components showing a high degree of
material. Observed transverse sections Highlights the collagen fibres of the matrix. cellular infiltration.
of pre-existing blood vessels which, while Observed absence of cellular material.
retaining their structure, ensure a more III. Hematoxylin-eosin staining of the

Bibliography
Berna G, Cawthorn SJ, Papaccio G, Balestrieri N. Evaluation of a novel breast reconstruction technique using the
Braxon® acellular dermal matrix: a new muscle-sparing breast reconstruction. ANZ J Surg, 2014.
Fahad M. Iqbal, Anjali Bhatnagar, Raghavan Vidya. Host Integration of an Acellular Dermal Matrix: Braxon Mesh in Breast
Reconstruction. Clinical Breast Cancer, 2016.
Maruccia M, Mazzocchi M, Dessy LA, Onesti MG. One-stage breast reconstruction techniques in elderly patients to
preserve quality of life. Eur Rev Med Pharmacol Sci, 2016.
Vidya R, Iqbal FM. A guide to pre-pectoral breast reconstruction: a new dimension to implant based breast reconstruction.
Clinical Breast Cancer, 2017.
Berna G, Cawthorn S. Absence of capsular contracture 4 years after prepectoral breast reconstruction with Braxon®
ADM: a case series. European Journal of Plastic Surgery, 2017.
Vidya R, Masia J, Cawthon S, et al. Evaluation of the effectiveness of the prepectoral breast reconstruction with Braxon®
dermal matrix: first multicentre European report on 100 cases. The Breast Journal, 2017.
Patented by

info@decomed.it

www.braxon.com