pfm medical remains at your disposal!
We will be available for you as usual during the corona crisis and have adapted our processes to ensure our continued delivery capability.

Dr. Donato Casella talking about prepectoral breast reconstruction with a new synthetic mesh pocket

Implant-based breast reconstruction is the most common method of breast reconstruction after skin- and nipple-sparing mastectomy. Why do you choose titanised meshes for this surgery?

"Breast reconstruction is a goal nowadays that can be achieved more easily and with a much greater cosmetic satisfaction for both women and surgeons. An implant reconstruction is the preferred way of achieving such a result, and a 2-stage procedure is the most common solution. A single-stage procedure is an interesting option whenever anatomical and oncological characteristics allow it.

The introduction of soft-tissue replacement devices dramatically expands this field in breast surgery. A lot of data are present in literature for use of ADMs in breast reconstruction. Synthetic meshes are used as well, as an alternative to ADMs with promising results in terms of capsular contracture.

In this regard the direct-to-implant subcutaneous reconstruction with a muscle-preserving technique, wrapping the implant entirely within a titanised mesh and placing it underneath skin flaps, showed excellent results in selected patients. 

Our experience demonstrates the safety and reliability of this technique, reporting satisfactory long term results with low complication rates. The rationale for our pre-pectoral TiLOOP® Bra use was simply based on the premise that it shows significant minor flogistic histopathological reactions when compared to other polypropylene meshes.

The main advantages are represented by the preservation of the pectoralis major muscle with reduced or absent muscular pain and a comparable rate of other minor complications, less invasiveness, reduction of surgical times (one-stage technique), early discharge and rapid recovery. Animation due to muscular contraction, rotation or mobilization of the prosthetic device are prevented, since it is completely placed in a preceptorial position, wrapped by the mesh and secured to the muscular fascia with stitches. The product is strong and mildly elastic at the same time, allowing for DTI and 2 - stage expander reconstructions.

Our outcomes for quality of life confirm high patient satisfaction suggesting that immediate pre-pectoral breast reconstruction with TiLOOP® Bra has the potential for providing a safe and valid reconstructive alternative."

If TiLOOP® Bra already eliminates the essential drawback of the sub-pectoral surgical procedure, why have you developed TiLOOP® Bra Pocket together with pfm medical? Do surgeons need both types of meshes?

"Whenever possible, surgical procedures should always be simplified in order to achieve high-standard results with the lowest efforts.

TiLOOP® Bra already offered an easy and fast alternative to submuscular reconstructions, nevertheless, depending on the size of the prostheses to be used, the intraoperative procedure of ‘wrapping’ the implant in a TiLOOP® Bra ("blanket") could result in longer surgical time or the need of an adjunctive surgeon dedicated to its preparation, longer exposure of the mesh to environmental and potential infective factors and even the use of two ‘sheets’ sutured together instead of one single ready to use product.

TiLOOP® Bra Pocket is much easier to use. It will definitely reduce the surgical time of the reconstructive procedures and immediately fit the device, with no need of further manipulations, preventing infections and saving tissue in excess  with lower costs.

Nevertheless, I believe surgeons should take advantage of both products depending on the specific case they are faced with. Every patient is different and every single breast reconstruction has its own peculiar characteristics. For example, we are about to publish our experience with the use of TiLOOP® Bra for selected patients undergoing skin-reducing mastectomies and pre-pectoral reconstruction with a mixed dermal flap and TiLOOP® Bra "blanket"."

How do surgeons and patients benefit from pre-pectoral breast reconstruction with TiLOOP® Bra Pocket?

"Currently pre-pectoral breast reconstruction is experiencing an important revival, opening new promising horizons. I can report excellent results in the use of a totally subcutaneous reconstruction technique with TiLOOP® synthetic mesh, in terms of oncologic and aesthetic outcome and capsular contracture rate. Moreover, in my experience, I confirm patient-related satisfactory results and high patient comfort. 

In fact, the main drawbacks of submuscular reconstruction such as the pain and discomfort associated with the elevation of the pectoralis major muscle, as well as the animation and lateral displacement of the implant during muscle contraction in the postoperative period are eliminated. Anatomically the sub-pectoral placement of implants is unnatural as the female breast overlies the pectoralis major muscle. In this regard I believe the pre-pectoral technique provides a more natural aesthetic result while avoiding the negative sequelae of raising the pectoralis major and submuscular implant positioning. 

Surgeons save costs and time, and have an easy learning curve with more flexibility in selecting the best implant to fit the skin envelope thanks to the possibility of choosing among the three sizes of TiLOOP® Bra Pocket, with lower risk of intraoperative and postoperative complications. Patients experience shorter surgeries, faster recovery and no muscular damage with painless, full, immediate mobilization of the arms leading to an early return to daily activities."

What are the benefits of the pre-pectoral breast reconstruction with titanised meshes compared to other meshes or ADMs?

"Recently it has been reported that the use of ADMs and synthetic meshes decreases capsular contracture rate, attributing the low capsular contracture to a diminished inflammatory response. In our experience we confirmed this trend, evaluating capsular contracture rate as low as 2%, similar to that reported in our previous studies.

As mentioned before, the rationale for our pre-pectoral TiLOOP® Bra use was based on the premise that it shows significant minor flogistic histopathological reactions when compared to other polypropylene or biological meshes. Seromas and infections are drawbacks of ADM use, highlighted in published studies on this topic, both ranging from 0 to 9%, in direct-to-implant reconstruction  as reported by in literature. We have been using ADM for years and we overcame our learning curve in soft tissue replacement devices using ADM. 

Our complication rates are similar or even lower than those reported in the largest series on other ADM use in breast reconstruction. This is probably due to the accurate selection of patients and to the peculiar conformation and characteristics of the TiLOOP® Bra. It is light and thin, but resistant and mildly elastic at the same time. The ‘net’ fashion framework allows continuous drainage of secretions, preventing the formation of hematomas or seromas between skin envelope and mesh, thus improving its process of integration and cellular colonization. This phenomenon leads to the formation of a new anatomical plan, a sort of ‘neo Fascia’ between the device and the subcutaneous layer. I believe this is crucial, since it represents the space to be filled in case of lipofilling for subsequent treatments or future corrections of wrinkling and rippling. Last but not least, of course, titanised meshes are cheaper!"

Are there studies that prove the security and benefit of titanised meshes for breast surgery?

"A lot of data are present in literature for ADMs and synthetic-mesh use in breast reconstruction. Made of a titanium-coated polypropylene mesh (TCPM), the TiLOOP® Bra has been approved for use in breast surgery in Europe since 2008. The growing interest in subcutaneous reconstruction has recently resulted into several studies with promising results in terms of oncological safety, effectiveness and capsular contracture, nevertheless larger studies with long-term outcomes are needed.

Two studies by our group have demonstrated its feasibility and safety and reported the short-term results of the first series of operated patients. Currently a long-term analysis extending the period of study and prospectively evaluating the health related quality of life (HRQOL) using the BREAST-Q and the outcomes of our subcutaneous breast reconstruction technique are in process for publication."

What is the significance of TiLOOP® Bra Pocket for the aesthetic breast surgery?

"Many women requiring aesthetic breast surgery could be sporty athletes, thin or skinny, without well-represented local tissues and unfavorable pinch tests. Or simply they might not want to have their pectoral muscles injured or limited in function by a surgical procedure for aesthetic purposes. Depending on local tissues conditions and on the patients’ desires, the TiLOOP® Bra Pocket could enlarge the spectrum of indications for a muscle-preserving breast augmentation stopping surgeons from performing a dual-plane or submuscular technique, thus avoiding muscular involvement in surgical aesthetic procedures."

What trends do you expect in reconstructive breast surgery and on what do these developments depend?

"The introduction of tissue matrices, either biological or synthetic, opened new horizons in implant-based breast reconstruction. Furthermore, the widespread availability of synthetic matrixes has led to novel approaches making possible the concept of a total pre-pectoral approach in breast reconstruction, allowing for a more natural placement of the implant in the subcutaneous plane.

These devices provide an opportunity to enlarge the spectrum of treatments and surgical therapies enabling definitive implant-based breast reconstruction in a one- or two-step technique, thus reducing the burden on patients and decreasing health-care costs.

Pre-pectoral breast reconstruction exhibits encouraging data in terms of aesthetic outcome and capsular contracture over a long-term period of evaluation. Skin-flap viability and wound healing are of utmost importance for its successful performance. Present results lead to a consideration of the muscle-preserving subcutaneous approach as a valid alternative to the standard retropectoral technique. As much as conservative mastectomies have changed the breast surgical oncology scenario, a ’conservative reconstruction’ paradigm is worth considering."

Our interview partner

Dr. Donato Casella is a specialist for breast reconstrution in Italy and has worked with pfm medical on the development of TiLOOP® Bra Pocket.