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Breast restoration

Method of single-stage breast mammoplasty by first domestically produced cover-less intra-tissue breast implant "Nubiplant" ™ (State Registration Certificate N7550/2008) after subcutaneous mastectomy due to cancer.

It is proposed for practical implementation with onco-surgeons, general and plastic surgeons in hospitals, scientific-research institutions, clinics, and higher education institutions.

In Oncology Department Clinics of P.L. Shupik National Medical Academy of Post-Graduate Education on the basis of Kyiv City Oncological Hospital of MoH of Ukraine was developed and implemented method of single-stage breast mammoplasty by first domestically produced cover-less breast implant Nubiplant™ after subcutaneous mastectomy due to cancer.

Breast cancer (BC) remains burning issue of modern clinical oncology in Ukraine. It is due to gradual and constant yearly morbidity increase by 1-2% and tendency absence for mortality stabilization. The mortality rate among women in economically developed countries is 18 cases for 10 000 persons – in Ukraine it exceeds 30. Among 15 thousand women, who fall sick with BC in Ukraine every year, 14% receive only surgical treatment, and 65% receive combined and complex treatment. At that surgical treatment in majority of cases means Peity radical mastectomy, Madden or Holsted-Meyer radical mastectomies, which are accompanied by breast extraction and regional lymph node dissection at various levels Organ-preserving surgeries in BC at tumor primary stages are not sufficiently grounded oncologically due to high local relapse risk of malignant tumor in preserved breast lobes. All above said calls for need to develop modern treatment methods for BC patients with obligatory all organ extraction. However, such surgery involves severe injury, to which many patients do not agree, and so they refuse from this single radical treatment method, proposed by doctor. Therefore remains actual searching for alternative modern treatment methods in BC patients that should combine unique curative surgery properties and esthetic aspects, which basic component is breast mass preservation in radical surgical extraction.



Ratio between breast surgeries and breast endoprosthesis replacement in 2001 – 2010
Single-stage and delayed endoprosthesis replacement after radical mastectomy due to malignant tumors with further radiotherapy
Breast form correction and volume increase
Single-stage endoprosthesis replacement after benign tumors extraction
Quadrantectomy with single-stage endoprosthesis replacement

At present this problem solving is possible due to use of methods of extracted breast restoration by auto-tissue complexes, mobilized and transferred from anterior abdominal wall or spine, which replaces extracted breast mass; or due to newest breasts endoprostheses use, which are developed and implemented by foreign companies. However, we should admit that existing foreign endoprostheses are characterized by considerable constructive drawback as outer covering and liquid silicon filler, which often leads to their excessive vulnerability to daily traumas and medical manipulations (punctures), after which product cover is broken and endoprosthesis filler is leaked under skin, and as a result esthetic operation result is degraded. Not allowing for such severe mammoplasty complication is research goal, aiming at creation of more complete breast endoprostheses.

With such demands comply coverless intra-tissue breast implant Nubiplant™, developed in Ukraine and clinically tested in Oncology Department Clinic of P.L. Shupik NMAPGE during endoprosthesis replacement of partially or completely extracted breasts in BC patients. The proposed breast mammoplasty method prevents patients’ psychological trauma, increases their motivation for radical surgery and foresees further operative treatment stages.

In order to prevent post-operative scar formation on skin covering breast, after sector resection or lumpectomy skin incision is recommended to complete along submammary fold. At first stage mammary gland is dissected from pectoral fascia, and then – from skin. After breast tissue extraction on operative wound lateral side surgeon extracts by electro-knife subcutaneous tissue together with Sorgius group lymph nodes. To accomplish this external boundary of greater pectoral muscle is mobilized and surface of serratus is cleaned. Aiming at prevention of endoprosthesis shifting to axillar zone, external edge of greater pectoral muscle, serratus and internal surface of skin outer edge are fixed by separate interrupted sutures. With the same goal skin at III-IV ribs level is fixated in semi-circle by separate sutures from absorbable sutures to pectoral fascia. The latest manipulation secures endoprosthesis stable localization in its installation place during its long-term use, and does not allow for product shifting to sub-supraclavicular zone.
Gradually hemostasis is completed, and into formed cavity surgeon implants endoprosthesis of appropriate size and form. Into wound two drainage tubes are obligatory installed, which are brought out on anterior abdominal wall skin. To tubes ends vacuum pump is attached. In skin submammary fold wound is stitched by two-raw cosmetic stitch, for the last obligatory is absorbable surgical suture. In case of uncomplicated post-operative drainage tubes are extracted by day three.

During first 8 to 10 days of post-operative period patients are prescribed antibiotics in preventive doses, analgesics, as well as medicines, decreasing tissues edema and normalizing tissues trophicity that secure uncomplicated wound healing (Detralex, Wobenzyme). During early post-operative period two times with three days interval patients undergo operated breasts ultrasound, with aim to discover subcutaneous wound exudate accumulations. In case of such complications discovery fluid accumulations are eliminated by punctures.

In case of appropriate indications patients after subcutaneous mastectomy during breast endoprosthesis replacement in cancer undergo radiotherapy, which is completed in case of post-operative complications absence, two weeks after surgery. Post-operative radiotherapy is completed in such patients group according to the general procedure in total dose of 42 Gr. Considering existing experimental data about stability of physical-chemical content of intra-tissue implant Nubiplant™ under dose 40 to 80 Gr, such complication as local seromas formation is regarded as usual surrounding tissues reaction, which is effectively and totally eliminated by desensibilization medicines and immune-radioprotectors course.
Subcutaneous mastectomy application with extracted tissues replacement by intra-tissue implant Nubiplant™ allows restoration of patient primary breast form, prevention of post-operative scar formation on skin, intra-operative diagnostics of sentinel lymph node and, according to obtained data about its morphological condition to determine indications for type of regional lymph node dissection in lymph nodes axillar group.

Considering the above said, we recommend:
in case of established indications for BC surgical treatment, as alternative to organ-preserving surgery, Peity radical mastectomy, Madden or Holsted-Meyer radical mastectomies, we recommend subcutaneous mastectomy with sentinel lymph node extraction and further breast tissue replacement by domestically produced coverless intra-tissue implant Nubiplant™;
use of breast coverless endoprostheses after its surgical removal due to cancer should be regarded as part of combined and complex treatment.

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