Engineering, 2012, 5, 72-75
doi:10.4236/eng.2012.410B019 Published Online October 2012 (http://www.SciRP.org/journal/eng)
Application of Mammary Gland Endopros thesis without a
Shell in Modern Oncomammological Practice
S. D. Myasoyedov, D. V. Myasoyedov, P. S. Moiseyev
The Oncology Cathedra Clinic National Medical Academy of Postgraduate Education (NMAPE),
n. a. P. L. Shupyk 69 Bd., Verkhovynna Str., Kiev, Ukrain e
Received 2012
ABSTRACT
Immediate an d late fol lo w-up results of oncomammological application of novel Ukrainian endoprosthesis “Nubiplant”, made of one
piece of polyacrylamide gel, for mammary gland malignancies (MGM) radical treatment with reconstruction were analyzed. This
endoprosthesis have proved its unique complex of favorable surgical and oncological properties, such as the shape and size accom-
modation for mammary gland plasty purposes, absence of shell and t extur ed su rface. O f 18 4 p atients, operated on radically for initial
stages of MGM, using “Nubiplant” endoprosthesis, postoperative complications have had occur in 18 (9,8%): the wound seroma in
12 (6,5%) and partial necrosis of cutaneous edge of postoperative wound – in 6 (3,8%). The seromas were successfully treated by
their punctures and local necrosis - using excision with secondary suture placement. Late follow-up results were obtained in 112
(60,9%) patients: three-year period have had survived 104 (92,6±2,4%), and a five-year one – 84 (75,0±4,0%) of them. A contracture
capsul e was revealed in 3 ( 2,6%) patient s, and excised with the endoprosthesis change. “Nubiplant” endoprosthesis have advantages
over most popular worldwide kinds of such products. It may be used securely and effectively for total or partial reconstruction of
mammary gland, including cases with hypoplasia, and is more resistant to trauma, radiation therapy and local complications occur-
rence, i ncludi ng contract ure capsule formation. Its property to absorb the water may be used for purposes of plastic surgery. Prophy-
laxis of specific immediate surgical complications is trustworthy in MGM patients, using modified endoprosthesis “Nubiplant”, con-
taining insulin, antihistamine and antiseptic medicin es .
Keywords: Mammary Gland Malignancies; R adical S urgical; Combined and Complex treatment; Endoprosthesis “Nubiplant”;
Immediate and Late Resu lts; Complications; Prophylaxis
1. Introduction
The optimal treatment development for mammary gland ma-
lignancies (MGM) still remain one of the main problems in
medicine and biology [1, 2]. The reason for this is a steady raise
of MGM incidence and mortality in majority of countries all
over the world. In Ukraine, in which the same epidemiological
tendency for MGM is observed, among total quantity of 960
000 cancer patients, followed today, there are 143 000, suffer-
ing MGM. Every year in Ukraine up to 15000 a newly diag-
nosed MGM cases are registered in women and 140-150 – in
men, what constitutes 35,7 cases per 100000 of population [3].
The every year raise tendency for MGM in Ukraine coincide
with a similar one in highly industrially developed countries
because of a global processes impact, which are characterized
by epidemiological-demographic transition situation of the
population age increasing, the infectious diseases incidence
lowering and chronic noninfectious diseases raising.
In Ukraine MGM holds a leading position in the oncological
morbidity structure in women. Today in the country the essen-
tial tendency persists to diagnose MGM in early stages. In 2009
among newly diagnosed MGM cases 75,5% were revealed in
the I-II stages and 14,3% - in the III [3]. It occurs because of
nowadays greater attention in country to solving of issues, con-
cerning prophylactic examinations conduction for mammary
glands p remalignancies an d cancer screening, wid e oncol ogical
education provided for population in mass media, paying atten-
tion to MGM early symptoms and its other clinical signs. This
favorable shift in a MGM patients contingent made it possible
to provide for them progressive, mainly organpreserving, strat-
egy of treatment. Thus, organpreserving and simultaneous plas-
tic sur gical pro cedures h ave become for MGM much more, and
even the most, popular [4, 5, 6 , 7]. In stead of rad ical mastecto-
my universal performance, using a Patey-Dassen method, now
subcutaneous mastectomy and organpreserving methods are
prevailing in The Kiev’s City Clinical Oncological Centre prac-
tice [7]. For these modern methods of surgical procedures var-
ious widely available mammary gland mass substituting endo-
prosthesis are applied, majority of which have a silicone con-
tent and a silicone shell.
After experimental investigation of endoprosthesis “Nubip-
lant” [8] its clinical follow-up results were analyzed [7].
2. Materials and Methods
Physic-chemical and clinical properties of endoprosthesis “Nu-
biplant” were studied in experiments on laboratory rats in ac-
cordance with the Local Ethic Committee approval [8]. Since
2005 this endoprosthesis is applied in The Clinic of the Oncol-
ogy Cathedra of NMAPE n. a. P. L. Shupyk in The Kiev City
Clinical Oncological Hospital. This novel Ukrainian mammary
gland endoprosthesis “Nubiplant”, certified in Ukraine and

S. D. MYASOYEDOV ET AL.
73
European Union, made of one piece of polyacrylamide gel and
proved its apyrogenic and biocompatibility properties. This
product is manufactured in various forms and sizes, and due to
its physic-chemical governed changeability is promising to
meet special needs of no w dominati ng organp reserving su rger y
for MGM. Thus, wider application of this novel product makes
possible to realize a personalized tactics and more adequate
procedure choice in modern reconstr uctive surgical treatment o f
MGM. “Nub iplant ” differs fro m anal ogues, becau se consti tutes
a homogenous mass without a shell and makes possible not
only to compensate the whole excised mammary gland mass,
but also to cut it in pieces of any form and size to substitute the
mammar y gland removed as a whole o r any part of it after p er-
forming lumpectomy or section resection. The endoprosthesis,
in accordance with experimental investigations data, as well
owes complex of other specific surgical and oncological prop-
erties, such as resistance to radiation therapy adverse effects,
inclination to traumatic rupture and extrusion.
In last 10 years in the Сlinic there were performed 312 sub-
cutaneous mastectomies with simultaneous mammary gland
endoprosthesis operations, including 184 (58,9±9,1%) cases,
using endoprosthesis «Nubiplant», and endoprosthesis of
“Mentor”, “Silimed” or “McGhan” firms - in other patients.
Endoprosthesis «Nubiplant» were applied predominantly for
the mass restorati on of a totally excised mammary gland.
In a locally spread MGM cases we prefer to perform subcu-
taneous mastectomy with simultaneous mammary gland endo-
prosthesis. Skin incision we conduct along subcutaneous plica
in external direction up to anterior axillar line of a patient, what
makes possible to accomplish the sentinel node intraoperative
biopsy in case if it is palpable. When the sentinel node was
diagnosed as free of metastatic affection, lymphadenectomy
was not done. In histologically confirmed metastatic affection
of regional lymph nodes the axillary lymph nodes dissection
was performed in a routine fashion with excision of all three
stages lymph no d es in accord ance to Berg sch eme. In cases o f a
postponed mammary gland plasty performance, using musculo-
cutaneous flap, owing vascular pedicle, which was taken up
from the back of the patient or from anterior abdominal wall, a
complex restoration of the excised mammary gland mass was
more precisely achieved while simultaneous application of one
of these flaps and endoprosthesis “Nubiplant” of a certain size.
Thus, one of the main advantages of “Nubiplant” endopros-
thesis application in reconstruction for mammary gland tumors,
using organpreserving operations, comes from its uniform po-
lyacrylamide gel content, permitting to design a smaller endo-
prosthesis of various size and form.
It is well known, that one of contraindications for organpre-
serving o peration s performance i n surgical t reatment of nod ular
forms of MGM is mammary gland hypoplasia. In these cases
the most su itable reco nstruct ion of the excised mammar y gland
portion is accomplished, using a fragment of the shell lacking
kind of endoprosthesis, especially when lumpectomy is done.
This procedure is performed in a following manner. The opera-
tion begins with two circular cutaneous incisions, one of which
is done around areola down to the derma level and the second –
outside the first one by 3-4 cm, dissecting the skin on full its
width. As a next step, deepithelization of the skin around areola
is conducted and separation of all mammary gland surface
down to superficial fascia. A morbidly changed part of mam-
mary gland i s determined an d excised completel y. The equal i n
size and shape fragment of endoprosthesis is designed and ex-
cised from the whole “Nubiplant” endoprosthesis to substitute
the mammary gland defect accurately. Using separate sutures,
the edge of deepithelized part of the skin is fixed to the peeled
off mammary gland cutaneous coverage by putting it above
deepithelized skin. Then, the cutaneous wound edges, situated
over the deepithelized part of the skin, are regularly sutured to
the areola edge, using surgical thread with restricted term of
absorption. As a result a uniform kind of tension between su-
tured cutaneous wound edges and areola is achieved, permitting
to immobilize the endoprosthesis fragment preventing its dis-
position in late follow up period. This procedure permits to
prevent also the coarse cutaneous cicatrix formation and to
achieve bet ter mass an d form sub sti tu ting effect, ver y impo rt ant
for the organpreserving operations outcome.
Depending on individual patient indications established,
postoperative radiation therapy was prescribed in a total dose
up to 42 G. In presence of metastatic affection of regional
lymph nodes six courses of adjuvant chemotherapy were con-
ducted – on the first stage, using Cooper’s schedule, on the
second – using docetaxel and on the third – using one prepara-
tion from a taxans group. Hormonotherapy was conducted as
well – depending on the tumor receptors status, which was
revealed, using histochemical investigation of biopsy material.
Indication for chemotherapy conduction was also establis hed in
accordance with absence or presence of reaction (+3) of HER-
2-neu receptor status – while presence of such a reaction the
chemotherapy course was added by herceptin preparation pre-
scription.
Prophylaxis for postoperative morbidity in patients was
achieved by perioperative prescription to them of anticoagu-
lants (low-molecular heparins), antibiotics and analgetic prepa-
rations. In postoperative period prophylactic measures against
development of lymphostasis in ipsilateral to operation site
upper extremity were accomplished, using specific medicinal
prepar ations and a local massage.
3. The Results and Discussion
Of 184 patients, operated on radically for initial stages of MGM,
using «Nubiplant» endoprosthesis, postoperative complications
have had occur in 18 (9,8%). Of them local morbidities were
presen ted as a lo cal seroma i n 12 (6 ,5%) an d parti al necro sis of
cutaneous edge of postoperative wound – in 6 (3,8%). The se-
romas were su ccess fully treat ed by thei r pun ctures and necro sis
- using excis ion with second ary sutu r e placement.
Contrary to majority of endoprosthesis used nowadays, “Nu-
biplant” do not owe the shell and the filling material inside.
That’s why the risk for the endoprosthesis rupture and extrusion
while operational or home trauma is minimalized. “Nubiplant”
endoprosthesis also have no multiple defensive layers and ad-
hesive connection between the valve and the shell, constituting
a more stable structure. They also do not have a textured sur-
face, what lowers a rate of a contr acture cap s ule formation.
Postoperative radiation therapy for MGM was conducted in
all the patients. Of them postradiation epitheliitis have devel-
oped in 7 (3,8%) patients, which was eliminated, using con-

S. D. MYASOYEDOV ET AL.
74
servative treatment. Before clinical application, experimental
trial was con d uct ed on labo ratory an imals (rat s) to tes t radiat ion
influence on the polyacrylamide gel state. This experimental
trial have not demonstrated essential physic-chemical and
structural changes in specimen of polyacrylamide gel after ad-
justing to them external radiation in doses of 100, 200 and 300
G. In our patients we have not observed any postradiation
harmful effects on the endoprosthesis and surrounding tissues
after per fo rmance of ro utine postop er ative radiation therapy.
Also in experiment on laboratory rats was analyzed a unique
property of polyacrylamide gel, depending on technological
conditions applied during the process of its synthesis, to absorb,
store and then continuously deliver outside endoprosthesis
some chemical substances and medicines. Such properties of
technologically modified variants of polyacrylamide gel, con-
taining furacilline or antihistamine preparation, were manufac-
tured, using the endoprosthesis 5-6 h exposition to solution,
containing one of these medicines. The analysis of furacilline
content in postoperative drainage exudate have shown, that all
furacilline is leaving endoprosthesis completely for first 5-6
postoperative days. The endoprosthesis volume enhancement
after furacilline absorption was quite mild and did not add mor-
bidity to postoperative period course, including duration of a
serou s exudate l eakage. We have d emonstrat ed th e best cli nical
effect on postoperative period course while using highly active
medicines in a small volume, which were absorbed inside en-
doprosthesis preoperatively. It is important to apply these mod-
ified endoprosthesis individually in patients with proven risks
of local surgical complications occurrence, such as inflamma-
tory, suppuration, allergy and as a consequence of diabetes
mellitus comorbidity.
For example, the selectively modified endoprosthesis was
purposefully used in a young patient, suffering mammary gland
adeno sis, severe mastalgia and diabetes mellitu s type II. In this
woman a total subcutaneous mastectomy was performed on
both mammary glands, 4 years between the operations, with
simultaneous reconstruction, using endoprosthesis “Nubiplant”,
containing the absorbed insulin of prolonged activity. The im-
mediate and late postoperative cou r s es with follow-up were fre e
from morbidity.
In some other patients, owing the enhanced risk of puru-
lent-inflammatory and allergic postoperative morbidity, the
endoprosthesis, containing absorbed anti-inflammatory or anti-
histamin e medicines, accordin gly, were used. Thes e prophylac-
tic measures have permitted to lower essentially a total rate of
specific postoperative morbidity in MGM reconstructive sur-
gery.
The next special surgical property of technologically mod-
ified “Nubiplant” endoprosthesis is its capacity to enlarge in
volume step by step by 8-12 times due to water absorption from
adjoining organism tissues. In experiment, the polyacrylamide
gel specimen, placed in rat subcutaneously, upon several days
and weeks caused the overlying skin square increase due to its
significant extension above the steadily enlarging specimen
volume. This property of polyacrylamide gel may be used in
plastic surgery for enlargement of cutaneous flap in the donor
site and as an alternative procedure for the tissue expander
place ment.
Endoprosthesis “Nubiplant” have uniform 0,97 specific grav-
ity, thus maximally approaching that of mammary gland tissue.
Such a relatively high density of “Nubiplant” endoprosthesis
permits to palpate it easily and to localize, using roentgenogra-
phy and CT.
The safety and security of “Nubiplant” endoprosthesis are
proved by wide application for mammoplasty surgery in the
Clinic, they are biocompatible and apyrogenic. Late follow-up
results were obtained in 112 (60,9%) patients. Three-year pe-
riod have had survived 104 (92,6±2,4%) patients and a
five-year one – 84 (75,0±4,0%). Remote MGM recurrences
were revealed as a metastat ic a ffect io n of lungs, bon es and liver.
These metastasis have constituted the main cause of a can-
cer-specific death in our patients, because palliative treatment,
conducted in them, have gained mild efficacy for survival en-
hancement.
Among our patients a contracture capsule have developed
only in 3 (2,6%) of them, including twice in one patient during
a ten-year follow-up period. All these patients were operated on
for this complication using revision oeration - a contractile
capsule excision and the endoprosthesis change with the same
kind of endoprosthesis.
4. Conclusion
Organpreserving surgery and subcutaneous mastectomies with
simultaneous mammary gland endoprosthesis operations con-
stitute a first-line treatment option in MGM patients.
“Nubiplant” endoprosthesis have advantages over most pop-
ular worldwide kinds of such products, what was widely inves-
tigated in experimental and clinical settings. It may be used
securel y and effecti vely for to tal o r parti al reconst ruction of the
excised mammary gland , including cases with h ypoplasia. This
endoprosthesis is more resistant to trauma, radiation therapy
and local complications occurrence, including contracture cap-
sule formation. Its property to absorb the water may be used for
purposes of plastic surgery. Prophylaxis of specific immediate
surgical complications is trustworthy in MGM patients, using
modified endoprosthesis “Nubiplant”, containing insulin, anti-
histamine and an tisept ic medicines.
MGM radical treatment with reconstruction, using “Nubip-
lant”, answer adequately for a modern organpreserving mam-
mary glan d oncological surgery and combined treat ment needs,
guaranteeing th e lowest level o f specific po stoperative morbid-
ity in the aspects of prophylaxis of specific immediate and late
complications.
The novel “Nubiplant” endoprosthesis application in modern
oncomammological resection practice permits to restore the
mammar y gland mass, fo rm and precise desir ed dimensions.
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