GC Aesthetics (GCA): GC Aesthetics®, breast implants with prospective long-term proven safety data

The following post is a guest post from GC Aesthetics, an ISAPS Gold Global Sponsor. 

10 years data with more than 500 women enrolled provides clinical evidence of GCA´s breast implants safety and performance.

Silicone gel-filled breast implants have been commercially available for decades and are the most commonly used devices for aesthetic and reconstructive breast surgery1. Recent challenges in the industry have plastic surgeons and patients demanding devices with long-term data. A 10-year clinical study concluded that there was sufficient evidence to determine the long-term safety and performance of GCA® implants.

Key points of the study:

  • a large 10-year post marketing prospective clinical study that enrolled over 500 women.
  • 526 women were evaluated undergoing primary (423 patients) and revision surgery (103 patients)
  • 17 centers were involved (France)- multicentric
  • Almost 1000 implants were used: 995 textured mammary implants (Round Collection™ and The Matrix™), including round and anatomical medical grade silicone implants.

Complications were recorded at 3 months and annually thereafter for 10 years. Well-recognized Kaplan-Meier (KM) method was used to analyze key complications.

Results:

According to Kaplan-Meier 10-year cumulative risk estimates for primary augmentation cohort:

  • Rupture- very low rate 4.9%
  • Capsular contracture for Baker Grades III and IV- low rate 13.8%
  • Re-intervention (includingexplanation/exchange): very low rate 13.3%

Interestingly, most of the implant removals and exchanges were for non-medical, cosmetic reasons (malposition, scar, volume change, wrinkling, and mastopexy)2. No cases were reported for re-intervention for conditions such as autoimmune diseases and BIA-ALCL in that study.

Other key findings of this study:

Regarding ruptures, it is also interesting to mention that the rupture rate in this 10-year follow-up study remained significantly low 10 years post implantation with only a total of 16 ruptures in the total of patients from all the cohorts, giving a KM estimated cumulative risk of 3.8% per patient. It is important to mention that 25% of the ruptures were linked to non-spontaneous causes (i.e., mechanical trauma such as car accident).

No rupture cases were observed in reconstruction cohorts.

Regarding wrinkling, re-intervention rates for wrinkling were low whereby just 1 patient (across all cohorts) was reoperated on to correct this complication.

Furthermore, very few patients in this study required re-intervention due to ptosis. The authors believe that this may have been due to patients being very happy with their final cosmetic outcome despite experiencing slight ptosis in some cases.

It is also worth to mention that local complication rates including infection and seroma were low or 0 across all cohorts, with KM risk rates of 0.6% and 0.2% by subject.

Conclusions:

This clinical study demonstrates the long-term safety and efficacy profile through 10 years for GCA® round and anatomical silicone gel breast implants analysed.

  1. International Society of Aesthetic Plastic Surgery (ISAPS). 2019 Plastic Surgery Statistics Report. https://www.isaps.org/wp-content/uploads/2020/12/Global-Survey-2019.pdf. Accessed May 20th, 2021.
  2. Duteille F,et al. Ten-Year Safety Data for Eurosilicone’s Round and Anatomical Silicone Gel Breast Implants. Aesthet Surg J Open Forum. 2019 Apr 27;1(2):ojz012.

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