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Natrelle 410 extra-full projection silicone implants had low 2-year complication risk

Women undergoing breast reconstruction with Natrelle 410 silicone gel extra-full projection implants following mastectomy had a low risk of complications at 2 years, according to study results.

Researchers studied 2,795 women (median age, 50 years) who received at least one Natrelle Style 410 highly-cohesive silicone gel extra-full projection implant (Allergan) after mastectomy in two prospective, multicenter trials. Complication rates and patient and physician satisfaction were measured through pooled data collected for 2 years after implantation.

There were 4,912 devices implanted, with 76% of patients undergoing bilateral reconstruction. There were low complication rates at 2 years, with asymmetry (4.8%) and capsular contracture (3.3%) the most common complications.

Scarring (n=97), asymmetry (n=89), implant malposition (n=78) and infection (n=71) were the most common reasons for reoperation, with a cumulative risk of reoperation of 21.6% by patient and 16.6% by device.

The physician satisfaction rate was 96.3% and the patient satisfaction rate was 91.1% at 2 years. Also at that time, approximately 90% of the physicians reported that “the shape of the breast reflected the shape of the implants, and that the breast implant had maintained its original position,” the researchers reported.

“The safety profile of Natrelle 410 extra-full projection implants mirrors the safety profile of Natrelle 410 moderate-projection and full-projection implants in women undergoing breast reconstruction,” the researchers concluded. “Physicians and subjects were highly satisfied with the results of the implant surgery after 2 years.” – by Bruce Thiel

Disclosure: Cordeiro reports receiving financial and material support as a study investigator for Allergan. Please see the study for a full list of the other researchers’ relevant financial disclosures.