Three manufacturers—Allergan, Mentor, and Sientra—provide all breast implants used in the U.S. for augmentation and breast reconstruction. All three companies now offer contoured (anatomically shaped) cohesive silicone gel breast implants—is any one of them better than the others?
A new study shows that contoured gummi bear breast implants used for breast reconstruction have similar rates of complications and patient satisfaction, regardless of who makes them.
This study followed 695 breast augmentation and breast reconstruction patients ranging in age from 18 to 82 (mean age 42.7 years) over 10 years. All participants were patients of a single plastic surgeon; however, they were also included in an FDA clinical trial from 2001 to 2013. (Cohesive silicone gel breast implants were approved by the FDA in 2012, but they were available for pre-market approval studies during the previous 10 years.)
Of the patients, 384 (55%) had primary augmentation, 198 (29%) had secondary augmentation, and 113 (16%) had breast reconstruction. Contoured cohesive silicone gel implants from all three manufacturers were used:
Allergan 164 (24%)
Mentor 245 (35%)
Sientra 286 (41%)
Patients with Mentor breast implants for primary augmentation experienced significantly lower rates of complications, while women who had breast implants for secondary augmentation or breast reconstruction were found to have similar rates of complications regardless of the implant manufacturer; no statistically significant differences with regard to capsular contracture, rupture, rotation, or rippling were observed.
Rates of reoperation (additional surgical procedure related to the implant) or explantation (implant removal without replacement) were also about the same. This study didn’t compare the reasons for reoperation or explantation, but more women in the secondary augmentation and breast reconstruction groups had explantation than those in the primary augmentation group.
Both patient and surgeon satisfaction with the implants was initially high after 1 year, as previous studies have found, but declined at 5 years. Study authors noted that this dissatisfaction was likely related to issues such as capsular contracture, implant rupture, or other implant-related complications.
If you'd like to see a precise breakdown of the types of complications that occurred, take a look at the source study below.
Source: Doren EL, Pierpont Y N, Shivers SC, et al. “Comparison of Allergan, Mentor, and Sientra Contoured Cohesive Gel Breast Implants: A Single Surgeon’s 10-Year Experience.” Plastic & Reconstructive Surgery (2015): vol. 136, No. 5, pp. 957-66.