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SERI surgical scaffold increases patient satisfaction in implant-based breast reconstruction

At 1 year after breast reconstruction with the SERI surgical scaffold, patients reported a higher level of satisfaction with their reconstructed breasts compared with preoperative screening, according to interim study data.

The prospective, single-arm SURE-001 study involves 139 patients undergoing two-stage, implant-based breast reconstruction using the long-term bioresorbable silk-derived biological scaffold, SERI (Allergan). Patients will be followed for 2 years; however, interim data for 71 patients followed for 1 year after surgery were published recently in Plastic and Reconstruction Surgery.

According to the researchers, patients underwent tissue expander placement during stage one of reconstruction, with SERI sutured into place for soft-tissue support of the lower-breast mound. Once expansion was complete with drain placement, the second stage of surgery was performed, where the expander was replaced with a permanent breast implant.

Investigator mean satisfaction scores were 9.2 at 6 months and 9.4 at 12 months, where a score of 10 was equal to being very satisfied with results.

Compared with patient mean satisfaction scores at screening (3.6), patient satisfaction with the treated breast was 4.3 at 6 months and 4.5 at 12 months.

Adverse events occurred in 18 patients and most occurred within the first 6 months; however, none were related to SERI use, according to the researchers. Among the adverse events recorded, tissue necrosis occurred in 6.7%, seroma occurred in 5.7%, hematoma occurred in 4.8%, implant loss occurred in 3.8%, capsular contracture occurred in 1.9% and breast infection occurred in 1%.

Among patients who underwent radiation therapy, investigator satisfaction was significantly lower at 6 months compared with patients not treated with radiation therapy, according to the researchers. – by Abigail Sutton

Disclosures: Fine served on advisory panels and received funding through grants or contracts with Allergan. Please see the full study for a list of all other authors’ relevant financial disclosures.