Contoured cohesive gel breast implants by three manufacturers comparable
Contoured cohesive gel breast implants by three different manufacturers were found to have similar low complication rates and high satisfaction rates during a 10-year period, according to recently published study results.
Researchers conducted a prospective study of 695 patients (mean age 42.7 years) who underwent breast implantation with contoured cohesive silicone gel breast implants performed by a single surgeon. The patients were included in FDA clinical trials from 2001 to 2013. Complication rates for three implant manufacturers — Allergan, Mentor and Sientra — were compared.
Mean time of enrollment in the trials was 5.3 years. Twenty-four percent of patient received Allergan implants, 35% received Mentor implants and 41% received Sientra implants. Primary augmentation was performed on 55% of patients, while secondary augmentation had been performed on 29% of patients and breast reconstruction on 16% of patients.
In primary augmentation, patients with Mentor implants experienced the lowest total complication rate when compared with the Allergan and Sientra cohorts (P < .05). For secondary augmentation and reconstruction, there were no statistically significant differences between the cohorts.
“There was no statistically significant difference between implant group reoperation, explantation or capsular contracture rates,” the researchers wrote.
There were low rates for overall implant rupture (0.7%) and rotation rates (1.3%). Using a Likert scale for measurement, patient and surgeon satisfaction was initially high at 1 year and declined at 5 years.
“All three implant manufacturers perform similarly, with low rupture, rotation, rippling and capsular contracture rates,” the researchers concluded. “Contoured implants have been found to be both safe and effective, with high patient and surgeon satisfaction. We plan to discuss patient selection, implant choices and operative technique in a future article.” – by Bruce Thiel
Disclosure: The researchers report no relevant financial disclosures. Allergan, Mentor and Sientra were sponsors of the study and supplied a small stipend to cover the administrative costs of the study.