Study on implant-based mesh-supported breast reconstruction: results pave way for surgeons to make better decisions

05/28/2020

Implant-based breast reconstruction is an established surgical method used when a mastectomy has been performed due to breast cancer or as a prophylactic measure. The primary objectives here are the patient’s quality of life, and achieving a good cosmetic outcome post-surgery. The results from the TiLOOP® Bra study (PRO-BRA) by Prof. Dr Marc Thill et al., recently published in the European Journal of Surgical Oncology1, highlight the factors that affect quality of life for breast cancer patients. They also provide guidance in finding the best possible therapy solution for patients who have opted for implant-based mesh-supported breast reconstruction.

The TiLOOP® Bra study: putting the spotlight on the patients

In a prospective, single-arm, multicentre study, quality of life of the patients and the cosmetic outcomes after breast reconstruction with a titanised mesh implant (TiLOOP® Bra) were investigated. A total of 269 patients from eight German clinics were enrolled in the study. The participants had undergone either a skin-sparing mastectomy (SSM), a nipple-sparing mastectomy (NSM) or a modified radical mastectomy, followed by primary or secondary breast reconstruction using a titanised mesh implant. The primary objective of the study was to measure the patients’ quality of life (as a Patient Reported Outcome, PRO) 12 months after the breast reconstruction using the standardised BREAST-Q questionnaire. In addition, the cosmetic outcome was assessed both by the patients themselves and by two independent experts. Complete data on this are available for 210 of the 269 patients enrolled in the study.

A better process for deciding on therapy options leads to increased patient satisfaction

A follow-up on these 210 patients over a period of 12 months shows that patient satisfaction following implant-based mesh-supported breast reconstruction is influenced by factors such as radiation therapy, previous therapies, and the patient’s age. For example, with regard to the patients’ “sexual well-being”, patients who had not experienced any adverse events were significantly more satisfied (p=0.001) than patients who had experienced adverse events. The patients’ “psychosocial well-being” was negatively influenced by having undergone previous therapies (p<0.01). Younger patients were significantly more satisfied with their breasts after the surgery (p<0.01) than older patients.

The results demonstrate that patient’s satisfaction and quality of life are influenced by a number of factors which may be related either to demographics (e.g. age) or to therapy (e.g. radiation therapy, experience of previous therapies). The results from this large-scale, prospective, multicentre study can help physicians make better decisions when seeking the best possible therapy option for patients who wish to have implant-based breast reconstruction – ultimately leading to better patient satisfaction.

TiLOOP® Bra – study results confirm excellent quality

As a responsible manufacturer with the aim of improving patients’ quality of life, we at pfm medical set very high standards for our products, namely: reliability, premium-quality, and demonstrable benefits.
TiLOOP® Bra, a titanised mesh implant for implant-based breast reconstruction, has been used continuously worldwide for more than 10 years, Around 40,000 breastreconstructions have been performed so far.
The polypropylene mesh is titanised by a special plasma coating process which pfm medical uses, as the only manufacturer worldwide, for mesh implants. The advantages of the titanisation are proven by studies. The hydrophilic, titanised surface is associated with a lower risk of inflammation compared to simple polypropylene2, which means a lower scarring tendency.3
The titanised surface, together with the implant’s minimal weight and large pores (1.0 mm), provide the best possible foundation for a stable result, and for excellent tissue integration as well as optimum capsule quality due to good vascularisation and elasticity.

References

  1. Thill M. et al., Patient reported outcome and cosmetic evaluation following implant-based breast-reconstruction with a titanized polypropylene mesh (TiLOOP® Bra): A prospective clinical study in 269 patients, European Journal of Surgical Oncology (2020), doi: 10.1016/j.ejso.2020.04.009. [Epub ahead of print]
  2. Scheidbach et al. In vivo studies comparing the biocompatibility of various polypropylene meshes and their handling properties during endoscopic total extraperitoneal (TEP) patchplasty. Surg Endosc (2004) 18: 211–220
  3. Scheidbach et al. Influence of Titanium Coating on the Biocompatibility of a Heavyweight Polypropylene Mesh. Eur Surg Res (2004) 36: 313-317

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Short profile pfm medical

pfm medical is one of the leading German providers of special solutions in the healthcare sector. The Cologne-based family-owned company was founded in 1971, and has nearly 570 employees at twelve international locations. In 2018, pfm medical generated an EBIT (earnings before interest and taxes) of EUR 2.9 million with a turnover of EUR 109.9 million.

The medical product provider holds 320 granted property rights in over 85 patent families worldwide and markets a diverse portfolio comprising nearly 3,000 products in over 100 markets.

Its products span the following four medical focus fields: Surgery (e.g. drainage systems and titanised mesh implants), infusion (e.g. mobile electronic infusion pumps and implantable port catheters), histotechnology (e.g. blades and laboratory equipment) and cardiovascular technology (e.g. implantable occlusion devices for the interventional treatment of congenital heart disease and special catheters).

pfm medical combines products and services to a comprehensive package of solutions. For instance, the company provides training and advice to users such as medical practitioners, nursing staff, patients and their families to support optimal therapy outcomes in both inpatient and outpatient healthcare. When developing innovative solutions in close cooperation with leading medical practitioners and specialist partners, pfm medical invariably focuses on improving the quality of life of both users and patients.


Press contact
pfm medical ag                    
Martina Welters
Wankelstraße 60                    
50996 Köln                    
Tel.: +49 (0)2236 9641-370        
martina.welters@pfmmedical.com                

Titanized mesh implant for implant-based mesh-supported breast reconstruction.