Rupture Rate Analysis Silicone Implants

Three major FDA-approved companies, Allergan, Sientra and Mentor, have now provided us with their three-year rupture rate for both primary augmentation and revision augmentation.  Primary augmentation for Mentor, N=551 with 0.5%, revision augmentation, N=146, 7.7% and Sientra breast implant three-year rupture rate, N=1,115 for primary augmentation with 2.5% and N=362 for revision augmentation, 0.0%.

Finally, for Allergan silicone-filled breast implant three-year study, N=455 with 2.7% and for revision augmentation, N=147 rupture rate of 4.0%. It is notable that the highest rate of rupture was found in the Mentor secondary revision augmentation or the breast revision surgical patient.  The lowest rate within the kit is by the revision augmentation by Sientra, 0.0%. It is difficult to determine how this could be possible with a 0.0% secondary augmentation when there was a 2.5% rupture rate with a primary augmentation patient after three years with a Sientra implant.

The Allergan implant study shows 4.0% rupture after three years with secondary augmentation or breast revision patients. The lowest rate of primary augmentation rupture was found with the Mentor Corporation, 0.5% versus the 2.5% with Sientra and 2.7% with Allergan. How to interpret this data may be difficult in that comparative analysis may be impossible due to different methodologies for calculating the data.

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