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Natrelle 410 anatomical form-stable implants: High satisfaction, low complications at 10 years

In a 10-year prospective study, Natrelle 410 anatomical form-stable implants showed low complication rates and high patient satisfaction in a total of 941 women.

In this multicenter trial, data was captured at the initial clinic visit, at 4 weeks and 6 months after implantation, and then annually for 10 years.

G. Patrick Maxwell

Out of the 941 total women, there were 492 primary augmentations, 156 augmentation revisions, 225 primary reconstructions and 68 reconstruction revisions, across 48 US sites.

Primary measure of effectiveness was subject satisfaction at 10 years.

At 10 years, 96.2% of augmentation patients reported they were somewhat or definitely satisfied with their implants at 10 years.

MRI also was performed in 316 subjects at 1, 3, 5, 7, and 10 years after implantation to assess silent rupture.

As for safety, capsular contracture rates increased approximately 1% per year from the previously reported first six years of the trial. The final rates, after 10 years were 9.2% for augmentation, 11.9% for augmentation revision, 14.5% for reconstruction and 26.8% for reconstruction revision. Capsular contracture rates at 10 years was 51% lower than that reported at 10 years in the Natrelle round gel core study for primary breast augmentation, according to researchers.

Overall rupture rate in the MRI cohort was 16.4% (9.7% of implants). The researchers reported that overall complication rates remained low through 10 years aside from capsular contracture and rupture in less than 5% of women undergoing augmentation. Implant wrinkling and rippling rates were also very low.

The investigators found that at 10 years, the shape of the breast reflected the shape of the implant for 97.3% of augmentations, 95.8% of augmentation revisions, 91.8% of reconstructions and 100% of reconstruction revisions. The implants also maintained their original position in 93% or more of cases for all surgery subtypes.

Researchers attributed some of the long term success of the implant to its textured surface, called Biocell (Allergan) which helps to maintain implant stability and position within the body.

“Biocell is a macrotexture surface with irregular depressions that have an average diameter of 300 µ and it demonstrates an adhesive effect with surrounding native tissue after surgical implantation,” the researchers wrote.

The researchers concluded that Natrelle “marks a distinct departure from previous generations of breast implants by providing adequate shape stability to prevent significant implant collapse and a sufficiently textured surface to help hold implant position.”

-- by Abigail Sutton

Disclosures: Maxwell is an Allergan consultant, royalty recipient and stockholder. Bengtson and Natta are consultants for Allergan and received support for conducting this study. Murphy is an Allergan employee and stockholder.