TILOOP®Bra immediate reconstruction...We finally performed an MRI study on the phantom, assessing the absence of surrounding artifact, any small movement or increase of temperature

BACKGROUND

Breast reconstruction has become a standard of care for almost all women requiring mastectomy for breast cancer, a procedure which actually represent a 30% of surgical indication, an approximately unchanged rate. Skin sparing (SSM) and nipple-areola complex sparing mastectomies (NSM) are becoming widespread ablative techniques, being oncologically safe and cosmetically superior to not-sparing procedures.

An “immediate prosthetic” reconstruction after mastectomy ensures benefits under a psychological profile and doesn’t affect the oncological safety. Compared to the double stage reconstruction it allows a prompt cosmetic result, improves patients’ compliance, declines a second surgical step and reduces costs and complications. Compared to the autologous reconstruction, it is rather less demanding, doesn’t require a team skilled for microsurgical techniques or a special operative equipment and could be done by surgical oncologist, trained in oncoplastic breast surgery. It also allows a shorter time of surgery and postoperative hospital stay and doesn’t restrict an eventual following autologous reconstruction.

In this framework, an immediate reconstruction of large breast volumes after SSM and NSM is an emerging issue. Particularly, in these cases the immediate prosthetic reconstruction could be difficult, since the skin exceeds the volume achievable in the retropectoral pocket. Indeed, until now reconstruction was provided by a double stage tissue expander/implant technique or by a single step autologous tissue one.

The introduction of titanized mesh may overcame the mentioned limits of reconstructive options, allowing an immediate prosthetic reconstruction even in the larger breast volume, after a conservative mastectomy. In our pilot study we used the “Tiloop bra”, a tissue supporting polypropylen mesh with covalent bonded titanized surface, knitted out of monofilament fibers, with laser-cut and rounded edges. It is an extra-light material and shows a tissue–like flexibility and high biocompatibility, with a minimal inflammatory reaction to the alloplast.

A NEW PROSTHETIC IMMEDIATE LARGE VOLUME BREAST RECONSTRUCTION: A TITANIZED POLYPROPYLENE MESH (TILOOP®Bra)

G. Garganese1, S. Fragomeni1, D. Cervelli2, G. Corrado3, P. Paparella1, G. Scambia4

1 -‐ Urogynecology and ReconstrucCve Surgery of Pelvic Floor Unit, AssociaCon Columbus, Catholic University of Sacred Heart, Rome, Italy. 2 -‐ Maxillo Facial Surgery Unit, AssociaCon Columbus, Catholic University of Sacred Heart, Rome, Italy. 3 -‐ Gynecologic Oncology Unit, John Paul II Hospital, Catholic University of the Sacred Heart, Campobasso, Italy. 4 -‐ Division of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome, Italy.


MATERIALS E METHODS

We considered to employ first TILOOP®Bra devices in patients not foreseen to undergo post-mastectomy radiotherapy (PMRT). However, we investigated if PMRT was feasible after the mesh implant, since indication could unexpectedly emerge from pathologic exam.

We finally performed an MRI study on the phantom, assessing the absence of surrounding artifact, any small movement or increase of temperature of the implant, confirming the safety of breast MRI after mesh implantation.

A dosimetric analysis and a TC scan-based treatment simulation were performed by radiotherapists: the mesh implant did not affect the plane of treatment work out and showed only some minimal attenuation and scattering processes; therefore the magnitude of dose perturbations from mesh was not relevant for clinical findings.

Pre-surgical study

We realized a phantom, implanting a retromuscolar prosthesis in a porcine hemithorax, supplying the cover defect in the inferior pole of the prosthesis with a Tiloop-bra. Everything was finally covered by a porcine skin layer.

MATERIALS E METHODS

Pilot series

From november 2010 to march 2011 we selected five patients eligible for Tiloop implantation.

Four patients were submitted to conservative mastectomies: one to NAC-sparing mastectomy and three to skin sparing mastectomy. In all patients an immediate prosthetic reconstruction was performed prolonging the pectoral coverage by tiloop implantation. A contralateral breast augmentation and/or pexy was also performed to reach a bilateral symmetry in each patient.


Moreover, in a single patient we resected the site of recurrence (LRR), occurred after a previous NSM and prosthetic reconstruction. The tumor infiltrated also the pectoralis major muscle: we resected a wide muscular area, removed and replaced the implant after capsulotomy and repaired the muscular defect by a tiloop-bra (small size).


Patient, tumour and treatment characteristics are summarized in the table 1. The size of anatomical prosthesis implanted after mastectomy ranged from 410 to 520 cc. A medium or large size of Tiloop-bra was employed for immediate breast reconstructions, while a small size was used to repair the muscle defect after the local recurrence exeresis. Immediate good symmetry was achieved in each case.

RESULTS

Wound healing come about in fifteen days. Pain after implant referred by patients was minimal, ranging from no pain to moderate pain according to the Verbal Pain Scale (VPC) despite the large volume of implants. No early complication occurred after surgery. After pathologic exam one patient underwent post-mastectomy radiotherapy (PMRT), which was performed without complications, and actually she is at the third month of follow-up. A second patient (case n.5) will be submitted to radiotherapy after chemotherapy completion. In only one case ultrasound study, performed after one and three month from surgery, showed hypoechoic spots shaped as “string of beads”. The CT images revealed only a thin hyperintense image and MRI didn’t detect any specific signs. The median follow up was 23 weeks.

CASE 1 CASE 2 CASE 3 CASE 4 CASE 5

Age (ys) 53 40 50 38 38

Type of surgery NSM SSM SSM SSM LRR

Contralateral surgery Augmentation Augmentation + pexy Mastopexy Mastopexy None

Histotype IDC IDC DCIS + PD IDC + DCIS IDC

Tumor diameter (mm) 15 15 18 13 30

Grading 2 2 3 2 2

Metastatic nodes 6/17 0/2 0/2 0/23 \

Stage IIIa I 0 I \

Centricity Multifocal Multicentric Multicentric Multicentric Multifocal

Neoadj-CT Yes No No Yes No

Adj-CT No Yes No No Yes

Adj RT Yes No No No Scheduled

Comorbidity No No No No No

History of smoking No No No No No

IDC – invasive ductal carcinoma; DCIS – ductal carcinoma in situ; PD – Paget desease

TABLE 1. Patient’s characteristics


RESULTS

TILOOP®Bra extra light titanized polypropylene mesh is an helpful surgical device which clearly improves reconstructive possibilities in the specific cases of medium and large breast after skin and NAC sparing mastectomies. It allows a single step prosthetic reconstruction without affecting the timing of post-operative treatments and the radiologic study (US, CT scan, MRI). In our pilot experience it improves post-operative pain and allows cosmetic satisfaction and a psychological good attitude. Obviously, we need to test larger series and to obtain more data about follow-up, late complications as capsular contracture in the not-irradiated cases (expected to be lower) and mainly after radiotherapy, and recurrence rate (expected to be comparable).


1.  Reddy S, et al. Breast cancer recurrence following postmastectomy reconstruction compared to mastectomy with no reconstructionAnn Plast Surg. 2011 May;66(5):466-71. 2.  Radovanovic Z et al. Early complications after nipple-sparing mastectomy and immediate breast reconstruction with silicone prosthesis: results of 214 procedures. Scand J Surg.

2010;99(3):115-8. 3.  Breivik H et al. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. Epub 2008 May 16. 4.  Sharma R, et al. Management of Local-Regional Recurrence following Immediate Breast Reconstruction in Patients with Early Breast Cancer Treated without Postmastectomy

Radiotherapy. Plast Reconstr Surg. 2011 May;127(5):1763-72. 5.  Hugo D. Loustau, Horacio F. Mayer, Manuel Sarrabayrouse. Immediate prosthetic breast reconstruction: the ensured subpectoral pocket (ESP). Journal of Plastic, Reconstructive &

Aesthetic Surgery (2007) 60, 1233-1238. 6.  Jorge M. Fernandez Delgado et al. Immediate Breast Reconstruction (IBR) With Direct, Anatomic, Extra-Projection Prosthesis 102 Cases. Annals of Plastic Surgery, Volume 58,

Number 1, January 2007. 7.  Steven J. Kronowitz, M.D. Geoffrey L. Robb, M.D. Radiation Therapy and Breast Reconstruction: A Critical Review of the Literature. Plastic and Reconstructive Surgery Volume 124,

Number 2, August 2009. 8.  MA Plant, CG Scilley, M Speechley. Single-stage immediate breast reconstruction using a skin-sparing incision and definitive saline implants compared with a two-stage

reconstruction using tissue expansion plus implant. Can J Plast Surg. Winter 2009, Volume 17 Issue 4: 117-123. 9.  Marzia Salgarello, Eugenio Farallo. Immediate breast reconstruction with definitive anatomical implants after skin-sparing mastectomy. Br J Plast Surg. 2005 Mar;58(2):216-22. 10.  Elisabeth R. Garwood BS, et al. Total Skin-Sparing Mastectomy Complications and Local Recurrence Rates in 2 Cohorts of Patients. Annals of Surgery-Volume 249, Number 1,

January 2009. 11.  Sara Reefy et al. Oncological outcome and patient satisfaction with skin-sparing mastectomy and immediate breast reconstruction: a prospective observational study. BMC Cancer

2010, 10:171.

REFERENCE

CONCLUSIONS

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TILOOP®Bra immediate reconstruction...We finally performed an MRI study on the phantom, assessing the absence of surrounding artifact, any small movement or increase of temperature