A short-term follow-up of implant based breast reconstruction using a titanium-coated polypropylene mesh (TiLoop Ò Bra)

Transcription

1 Available online at EJSO xx (2012) 1e6 A short-term follow-up of implant based breast reconstruction using a titanium-coated polypropylene mesh (TiLoop Ò Bra) M. Dieterich a, *, T. Reimer a, H. Dieterich b, J. Stubert a, B. Gerber a a Department of Obstetrics and Gynecology, Breast Unit, University of Rostock, Interdisciplinary Breast Center, Suedring 81, Rostock, Germany b Women Clinic and Breast Centre Rheinfelden, Therese-Herzog-Weg 2, Rheinfelden, Germany Accepted 23 August 2012 Available online --- Abstract Introduction: A new approach for implant based breast reconstruction (IBBR) is the use of a titanium-coated polypropylene mesh (TCPM) as an alternative to acellular dermal matrix (ADM). This TCPM has a good biocompatibility and can be used similarly to ADM. The aim of this study is to discuss indications, limitations and complications of TCPM in IBBR. Methods: A retrospective analysis of 42 patients undergoing immediate or delayed IBBR using a TCPM was performed. Primary endpoints were incidence of infection and expander/implant with mesh removal due to infected fluid collection or extrusion. Results: In two patients, mild hematoma, seroma or infection occurred. Skin necrosis or capsular contraction was observed in one patient. Mesh explantation was needed in 3 cases. These events were higher among the first cases and in patients with postoperative skin infection ( p ¼ 0.003). Conclusion: In selected patients with adequate soft tissue cover TCPM seems to be a helpful tool for implant stabilization in terms of lateral stabilization and fixation of the musculus pectoralis major. In comparison to ADM, TCPM is cheaper and initial results are promising, but further follow-up data are necessary. In patients with poor soft tissue cover ADM should be used. Ó 2012 Published by Elsevier Ltd. Keywords: Breast reconstruction; Mesh; Implant reconstruction; Acellular dermal matrix; Timesh; TiLOOP Introduction Skin- and nipple-sparing mastectomy (SSM, NSM) are oncologic safe procedures which have gained popularity over past years. 1 In course of primary breast reconstruction after SSM/NSM the gland can be replaced by autologous tissue or prosthesis. During prosthesis reconstruction the surgical extent and patients impairment is much lower than by autologeous tissue. The implant is usually placed in a partial submuscular or subpectoral position. 2e4 The pectoralis major muscle (PMM) provides additional cover in the two upper and the lower medial quadrant between the implant and the maximal thinned mastectomy flap. However, at the lower lateral part the implant is solely covered by a skin-fat flap. Here, little muscle is available to completely cover the implant. This can lead to a lack of support and increased implant palpability. The mobilization of the serratus or the anterior sheet of the rectus * Corresponding author. Tel.: þ ; fax: þ address: max.dieterich@uni-rostock.de (M. Dieterich). muscle can provide further muscular coverage, bearing the advantage of omitting extra supportive materials. Additional implant coverage can also be achieved by using allogen materials like acellular dermal matrixes (ADM) or a new titaniumcoated polypropylene mesh (TCPM), as previously described. 5 The possible advantage of this mesh in implant based breast reconstruction (IBBR) is to fixate the PMM to the inframammary fold (IMF) and stabilize the implant pocket laterally, without destroying further muscles tissue. Although meshes are used on a large scale, there are no appreciable data regarding safety and outcome. In this case series we report of immediate and delayed IBBR using TCPM. Patients and methods Design This is a retrospective evaluation of patient s who underwent mastectomy with immediate or delayed IBBR using TCPM. Patients were informed about the intraoperative decision of mesh use, depending on the intraoperative conditions /$ - see front matter Ó 2012 Published by Elsevier Ltd.

2 2 M. Dieterich et al. / EJSO xx (2012) 1e6 Patient demographics, previous or following adjuvant treatment, surgical procedure details and outcome were taken from medical records. Mesh removal due to immediate postoperative bleeding were excluded to prevent possible increasing risk of infections after hematoma removal in the inflammatory altered implant pocket. TCPM is approved for use in breast reconstruction (BR) in Europe. Approval of the institutional review board existed. Patient selection for TCPM BR was similar to those undergoing BR with ADM. 3,6e9 Study aims Primary study endpoint was mesh removal due to infected fluid collection or extrusion. Secondary endpoints were prevalence of seroma, wound/skin infection, hematoma, allergic reaction, number of days requiring drains, re-operation, capsular contracture rate and identification of possible risk factors or contraindications for TCPM in IBBR. In addition, a pubmed search was performed to compare our results to IBBR using ADM. The following key words were used: TiLOOP Ò Bra, titanium-coated mesh, Alloderm Ò, acellular dermal matrix, breast and breast cancer. Material description TCPM (TiLOOP Ò Bra, pfm medical, Cologne, Germany) is a lightweight mesh and consists of a monofilament structure. In comparison to common non titanium-coated meshes, such as heavyweight mesh made of pure polypropylene (PP), pure lightweight PP mesh or PP mesh incorporating resorbable polyglactic acid this lightweight TCPM has a much better biocompatibility. 10 In this study by Scheidbach et al, the observed cellular reaction, in terms of proliferation and apoptosis was at the lowest level when using a TCPM. Histopathological, immunohistochemical and molecular-biological investigations showed significant benefits in favor of TCPM in contrast to other PP mesh. Histopathologic analysis demonstrated significantly weaker inflammatory reactions when using TCPM. 11 Less pronounced inflammatory reactions and significantly less shrinkage were seen when using TCPM in comparison to the identical amount of not titanium-coated heavyweight PP mesh. 12 To investigate the biointegration of the TCPM, histological examination of an ingrown mesh was performed in a patient with expander implant exchange 3 month after mesh implantation. preoperatively to determine the length of the needed TCPM. After SSM/NSM was performed the subpectoral pocket is prepared. It is created in a standard procedure by elevating the PMM from the chest wall, mainly with blunt dissection. Electrocautery is used to free the muscle s origins along the IMF and the medial aspects. Once the subpectoral pocket is created the new IMF must be identified. In case no deepithelised dermal flap could be dissected the intraoperative decision was made to use TCPM. The TCPM, which already comes in an IMF like shape, can be sutured to the chest wall at the most infero-medial and infero-lateral point to reinforce the lower pole of the IMF. The TCPM can be reinforced with additional sutures along the new IMF to keep the implant in place. These interrupted sutures are not tied until the implant is in its final position. Then the implant is placed into the subpectoral pocket. Once the final implant position is obtained the sutures are tied. The free border of the inferior part of the PMM is then sutured to the other end of the TCPM (Fig. 1). Mastectomy incision is closed in standard fashion. Drains were used in all patients and discontinued when drainage was less than 30 ml/24 h. Prophylactic antibiotic treatment was used in all patients during and three days after surgery. Statistical analysis Statistical analyses were performed using IBM Ò SPSS Ò Chi square test was performed to compare numbers in groups and Fisher s exact test when chi-square test was intended but one or more of the cells had an expected frequency of five or less. A p-value <0.05 was considered to be statistically significant. Results Patient characteristics Over a 26-month period, 42 patients (45 breasts respectively) from two hospitals were evaluated. Median BMI Surgical technique Before surgery, patient s soft tissue conditions were evaluated for suitability for TCPM breast reconstruction. An alternative autologeous BR was discussed in general, and in case of poor soft tissue conditions. The IMF, the lateral mammary fold as well as the patients midline and anticipated skin incision are marked in standing position. It is helpful to measure the IMF Figure 1. Intraoperative picture of TCPM, left breast from (11).

3 M. Dieterich et al. / EJSO xx (2012) 1e6 3 was (range 17e32), indicating that most patients were thin. Median follow-up was months (range: 7e33). In 39 cases previous breast surgery was performed: eleven breast conserving therapies (BCT), two modified radical mastectomies (MRM), six SSM with implant reconstruction, nine BCT with sentinel lymph node biopsy, one MRM with autologeous reconstruction, eight axillary- or sentinel lymph node dissections alone and two breast augmentations. Most of the patients had final implant reconstruction. In only 4 patients, expanders were used which were exchanged for final implants after 3e6 months of completed adjuvant treatment. A postoperative result is shown in Figs. 2 and 3. Surgical characteristics Three patients underwent esthetic breast surgery. One had a breast augmentation in 1980 and presented for implant exchange. The second patient, with tubular breasts, had a previous breast augmentation elsewhere and surgery was performed for correcting the esthetic result. In the third patient, a mastectomy was performed in She had BR performing a latissimus dorsi flap with an implant in Another three patients underwent prophylactic mastectomy with IBBR due to BRCA 1 or 2 gene mutations. The remaining 36 patients had IBBR mainly after SSM or NSM. Seven patients had radiotherapy before and two after surgery with TCPM. Forty-two unilateral and three bilateral procedures were performed. Median implant size was cc (range 135e480). If expanders were used final expander expansion was included. In all patients TCPM and anatomical, textured implants from the same manufacture were used (Allergan Inc, Irvine, USA). Median number of days drains were in place was days (range: 3e14). Complications Complications occurred in eight patients and were distributed as follows: mild hematoma and postoperative Figure 3. Six month after skin sparing mastectomy and IBBR with TCPM, front view (left breast). seroma were observed in two patients and could be treated conservatively. Skin necrosis occurred in one patient, whereas skin necrosis was defined as dead skin due to infection or decreased postoperative vascularization. No mesh exposure occurred and skin necrosis could be treated conservatively with i.v. antibiotics, debridement and acceptable secondary wound healing. In one patient skin infection occurred immediately after surgery resulting in mesh removal. In another patient an infection of the skin and implant pocket was observed 1 month after surgery requiring revisionary surgery and mesh removal. Capsular contraction was seen in one patient three month after surgery. The overall explantation rate amounted to 6.7%. As expected, increased risk for mesh removal was observed in case of skin infection ( p ¼ 0.003, Table 1). No patient was lost to follow-up. Histological evaluation showed a well incorporated TCPM with fibroblasts and only little inflammatory invasion (Fig. 4). Discussion With the introduction of autologeous BR we have safe and cosmetically satisfying options for patients seeking BR after mastectomy. 13 However, with the enhancement and demonstrated safety of silicone implants, BR with implants gained popularity, as IBBR is a simple and oncologic safe procedure. The additional development of new materials, like ADM and TCPM, facilitating IBBR, contributed to its increase. Today IBBR is one of the most commonly performed procedures in patients who choose to have reconstruction. 14 ADM in breast reconstruction Figure 2. Invasive breast cancer (left breast) with accompanying DCIS after breast conserving attempt (before skin sparing mastectomy). In 2005, Breuing and Warren were one of the first to describe the use of ADM in IBBR. 4 Since then, this technique

4 4 M. Dieterich et al. / EJSO xx (2012) 1e6 Table 1 Risk factors for mesh removal. Risk factors Mesh preserved (n) Mesh removal necessary (n) p-value Smoking 0.58 a Yes 4 0 No 38 3 Hypertension 0.12 a Yes 8 2 No 34 1 Coronary heart disease Yes 1 0 No 41 3 Diabetes Yes 2 0 No 40 3 Previous surgery Yes 36 3 No 6 0 Primary or secondary 0.36 a reconstruction Primary 37 2 Secondary 5 1 Mild hematoma Yes 2 0 No 40 3 Skin necrosis Yes 1 0 No 41 3 Seroma Yes 2 0 No 40 3 Skin infection a Yes 0 2 No 42 1 ALND vs. SLNB ALND 9 0 SLNB only 24 1 SLNB alone 0.29 a Yes 28 1 No 14 2 ALND alone Yes 9 0 No 33 3 BMI 0.36 a BMI BMI > Radiation 0.67 b No 33 3 Before surgery 7 0 After surgery 2 0 Chemotherapy 0.65 b No chemotherapy 29 2 After surgery 6 0 Before surgery 7 1 Implant vs. Expander Implant 38 3 Expander 4 0 Revisionary surgery 0.08 a Yes 6 2 No 36 1 ALND: axillary lymph node dissection, SLNB: sentinel lymph node biopsy, BMI: body mass index. a Fisher exact test was used. b Chi square test was used. Figure 4. Paraffin section of the subcutaneous tissue biopsy three month after implantation of the TCPM. Fibers of the mesh (arrows), mild infiltration with inflammatory cells (arrowhead), magnification 100, H&E staining. has increasingly been used. Diverse authors addressed concerns regarding tolerance and safety of ADM in BR, and mainly individual surgeon reports were published with regard to surgical technique and safety 2e4,6,8,15e22 Followup and complication rates are comparable to our data. In a recent meta-analysis 12 studies were identified evaluating near-term postoperative complications in IBBR using ADM. With a mean follow-up of 13.7 months, a total complication rate of 12% was calculated (most common: flap necrosis 3.3%, seroma 3.3%, infection 5.6%). Nevertheless, a conclusion on long-term complications like capsular contraction could not be drawn. 23 TCPM in breast reconstruction Recently, we described the use of a TCPM in IBBR. 24 The histological evaluation showed a well-incorporated mesh with neo-vascularized fibroblastic tissue. A difference of our study to publications with ADM in IBBR, is a slightly higher explantation rate of 6.7% (n ¼ 3). This is most likely explained by the new procedure and the associated learning curve, including correct patient selection. 22 In the beginning, TCPM was also used in women with poor soft tissue conditions. In retrospect, the third case would not be an eligible patient for TCPM and IBBR. She had modified radical mastectomy (MRM) a few years before and desired secondary BR. Along with a body mass index of 19 kg/ m 2 she was not a candidate for autologeous tissue reconstruction. With status after MRM and poor soft tissue conditions the surgical procedure was very complex with elevation of the IMF and mobilization of a thoracoepigastric flap. The implant had to be removed three month after surgery and this patient was rather a candidate for ADM reconstruction. These cases emphasize the importance of patient selection. Nevertheless the learning curve

5 M. Dieterich et al. / EJSO xx (2012) 1e6 5 itself is not to be underestimated. From the existing results, TCPM for IBBR should be carefully used in very thin patients, in patients with lack of subcutaneous tissue and in revisionary implant surgeries. These cases might be more suitable for ADM. The TCPM itself is too thin to give enough implant coverage toward the skin. Area of application Although excellent esthetic results can be achieved using autologeous tissue, not all women desire autologeous BR or have enough tissue available. TCPM might improve IBBR in these patients. In case IBBR fails due to radiation changes or infection, salvage with autologeous tissue flaps can still be performed with acceptable results. 25 In case flaps are needed for other reasons (e.g. after accidents) they are still available. From our practice so far, TCPM is no soft tissue replacement like ADM. TCPM is more of a supportive tool to facilitate IBBR by fixating the PMM and stabilizing the implant pocket laterally in patients with sufficient soft tissue. In addition a better control of the IMF was achieved. Having used TCPM in different surgical settings (reconstructive and esthetic), associated with different soft tissue characteristics, our knowledge increased. A careful preoperative examination of the patient s soft tissue is essential for optimal results. From our experiences, TCPM can alternatively be used in the following patients: -Patients undergoing IBBR after SSM or NSM with well preserved skin soft tissue proportions -Patients with primary or secondary prophylactic subcutaneous mastectomy -Patients undergoing nipple areola complex sparing subcutaneous mastectomy and well preserved skin soft tissue proportions -Patients with tuberous breasts, Poland syndrome or other congenital deformities. The application of this lightweight titanized mesh combines the advantages of cost over artificial dermis, with the technical material advantages over much heavier, nontitanized meshes. Possible advantages in comparison to other meshes lie in its lightweight structure and consistence of monofilament structures. Tolerability In vivo investigations in pigs have shown good biocompatibility, supported by our histological findings. An experimental study using a porcine model revealed significantly weaker inflammatory reactions when using a titanium coated mesh in comparison to other non titanium-coated polypropylene meshes. 10,12 These studies are not completely transferable, as they are all animal studies in which no additional biomaterial was used. But they were a source to use this mesh over others, as the combination of two biomaterials (mesh and implant) bears increased risk for infections. During second stage surgery, the mesh felt very soft and flexible. Perioperative and clinical considerations To prevent possible infections, double drainage and prophylactic i.v. antibiotics over 3 days were used in the majority of the cases. As a result of the presented data, it seems that immediate postoperative complications can be avoided by careful patient selection and exclusion of high risk patients. The thickness of the available soft tissue plays an important role for successful surgery. The dissection of an additional deepithelised dermal flap, if possible, might be a supportive tool to increase the result when TCPM is used. Clinically, the mesh was pre- and postoperatively hardly palpable. The breast maintained its softness with a minimal palpability of the implant. In two cases, postoperative radiation was performed after expander and TCPM reconstruction. During expander/implant exchange, the external radiation seemed not to have any an influence on the resistance of the TCPM. In both cases the TCPM was left in situ. It was well incorporated and showed no signs of stiffness or other irritations. An unanswered question remains the effect on mammograms after IBBR with TCPM in patients after esthetic surgery, because those patients did not have a mammography with in the time this paper was written. However, the authors know of no interferences. General considerations A limitation to this study is the small sample size of 45 reconstructions with TCPM and a median follow-up of 20 month is too short to make a definite statement on the capsular contraction rate or late term mesh complications. A further limitation is the low level of evidence in this observational study and lack of a control group. No attempt was made to determine the degree to which postoperative complications influenced patient satisfaction or long-term success of the reconstructive procedure. For further safety and long-term results we started a register study in cooperation with multiple Breast Centers in Germany. These data will help evaluate the safety and long term results of TCPM in BR. As a result of the presented data the use of TCPM in IBBR must still be cautiously evaluated. In pre radiated patients the tolerability of TCPM is unclear and should carefully be used. Different biologic matrixes have proven to be reliable options in patients undergoing IBBR. Nevertheless these matrixes are very expensive and not affordable for all patients. The TCPM in comparison is a two- three fold cheaper option, which can be used in the described patients. TCPM might be a possible new material for IBBR but further data and research is needed. An additional focus should be the use of TCPM together with other available implants to examine their biocompatibility, as surfaces

6 6 M. Dieterich et al. / EJSO xx (2012) 1e6 and texturations of each manufacturer are different, bearing the risk of interactions between the two materials. Conclusion Although the number of patients is small in this study, evaluated patients and results are comparable in resemblance to previous publications of IBBR with ADM. Patients should be counseled about possible postoperative risks and alternatives, like autologeous techniques. TCPM can be a supportive tool to facilitate IBBR by stabilizing the implant pocket. However, it must be pointed out that TCPM is not a material to increase the soft tissue conditions like ADM. For the right indication TCPM is a less expensive and possible alternative to ADM. Longer follow-up data and additional clinical reports are necessary to evaluate the use of this mesh in daily practice. Funding All costs were handled by the hospital and the authors themselves and the University Hospital Rostock. No funding from third parties was received. Conflict of interest statement All authors disclose any conflict of interests. Acknowledgment The authors thank Julia Kremer for English proof reading. References 1. Gerber B, Krause A, Dieterich M, Kundt G, Reimer T. The oncological safety of skin sparing mastectomy with conservation of the nippleareola complex and autologous reconstruction: an extended follow-up study. Ann Surg 2009;249(3): Spear SL, Pelletiere CV. Immediate breast reconstruction in two stages using textured, integrated-valve tissue expanders and breast implants. Plast Reconstr Surg 2004;113(7): Spear SL, Parikh PM, Reisin E, Menon NG. Acellular dermis-assisted breast reconstruction. Aesthetic Plast Surg 2008;32(3): Breuing KH, Warren SM. Immediate bilateral breast reconstruction with implants and inferolateral AlloDerm slings. Ann Plast Surg 2005;55(3): Dieterich M, Gerber B. Patient selection and technical considerations in nipple-sparing and areola-sparing mastectomy. 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