Breast conserving surgery using oxidized regenerated cellulose as filling biomaterial: recommendations to improve clinical outcomes

I have browsed with interest the article of Li and colleagues published in “BMC Women's Health” [1] and would like to provide some useful remarks to optimise the clinical use of oxidized regenerated cellulose (ORC) as a filler in breast conserving surgery (BCS).

ORC is a bioabsorbable, sterile material prepared by the controlled oxidation of regenerated cellulose; It is composed of cellulose that is a homopolysaccharide of glucopyranose units polymerized together by beta [1‐4] glycosidic bonds, regenerated to create organized fibers [2].

ORC is an optimal hemostatic agent that may be left in the surgical breast site to control bleeding thanks to ease-of-use and favourable biocompatibility [2, 3]. Once the ORC has been saturated with blood, it forms a black or brownish lump with a gel-like consistency that allows the clot formation, so acting as an adjuvant in the process of local hemostasis [2‐4]. In addition to its local hemostatic properties, ORC has bactericidal activity thanks to its ability to reduce pH levels below 4.0, blocking bacterial growth and survival [2].

Recently, ORC has also been used as a filler in BCS with a reconstructive purpose in order to repair partial breast defects and improve the aesthetic outcomes [4‐6].

Li et al. [1] have reported that “oxidized regenerated cellulose and gelatin sponge are feasible filling materials for partial breast defects” and can be useful in BCS in order to optimise cosmetic results; the evaluation of aesthetic outcomes, 6 months after surgery using the Harvard breast cosmetic grading scale, has documented very positive results in 18 patients in the ORC group and 15 patients in the gelatin sponge group [1].

Our previous clinical experience has shown that the ORC (Tabotamp Fibrillar® 10 × 10 cm, Johnson & Johnson; Ethicon USA) is a safe aid to minimize the risk of postoperative haematoma and optimise the cosmetic results in patients undergoing breast conservative surgery [5].

However, in order to perform a conscious and proper use of ORC in BCS, it is crucial to know its potential benefits but also some possible issues that can cause a negative impact on clinical outcomes; ORC can determine, like other biomaterials, allergic skin reactions, seroma as consequence of excessive digestion and foreign-body reaction with risk of extrusion due to its sub-optimal and inadequate absorption [4‐7]. When ORC has been used in BCS, a significant postoperative seroma, high rate of red syndrome with acute dermatitis and eczema and some cases of foreign body reaction, that required surgical removal, have been reported [4‐7].

These possible surgical complications can undermine clinical outcomes and lead to delay the beginning of oncological treatments with a negative impact on patient quality of life, survival and hospital costs.

Furthermore, specific radiological findings due to the fibrogenetic ORC-induced reaction and its partial absorption, can cause diagnostic mistakes and false alarms during the follow-up of breast cancer patients, if not properly interpreted; a previous experimental study on Wistar rats has analyzed the tissue reaction to locally implanted ORC and reported that its absorption is not always complete, resulting in biomaterial retention [4]; this trial has shown that tissues present chronic inflammation, central liponecrosis, neoangiogenesis (both centrally and periphery; homogenous vascularization) and diffuse fibrosis that is stable at postoperative week 30 when the ORC is used [4]; an excessive and improper fibrogenesis due to ORC can culminate in the creation of a three-dimensional fibrotic structure with a peculiar imaging and enhance the risk of diagnostic mistake during follow-up. The use of ORC may cause a granulomatous reaction that may mimic recurrent or progressive tumor, abscess, hematoma sequaele or area of fat necrosis on postoperative imaging studies creating a difficult challenge in differential diagnosis [2‐4]; in our clinical experience with ORC in breast conserving surgery, postoperative mammography and ultrasound imaging have shown a typical lesion with circumscribed margins and internal hyperechoic nodules that we have called “ile-flottante” [7, 8]; breast magnetic resonance imaging (MRI) has confirmed a specific pattern with a well-encapsulated, hyperintense collection with circumscribed margins and internal hypointense nodules on the T2-weighted and short tau inversion recovery (STIR) sequences [9].

In view of previous considerations, the breast surgeons should always follow some specific and standardized recommendations to optimise aesthetic outcomes and minimize postoperative issues (Fig. 1):

In conclusion, I agree with Li and colleagues that the application of ORC can be a feasible option in order to optimise aesthetic outcomes in breast conserving surgery as long as some specific and standardized tasks are always performed by skilled breast surgeons.