Safety and Effectiveness of Mentor’s MemoryGel Implants at 6 Years
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In November 2006, the FDA approved the Premarket Approval PMA applications for the round, cohesive, silicone gel-filled breast implants of Mentor (MemoryGel) and Allergan. Since that time, the devices have been widely available to plastic surgeons and their use is rapidly eclipsing that of the saline breast implants. Patients in the Core clinical studies supporting these approvals continue to be followed through for 10 years, with comprehensive annual patient and physician-reported evaluations of safety and efficacy.
One thousand and eight (1,008) female patients had data collected on 1,898 implants, and were enrolled at 48 sites. Key complication rates were recorded with Kaplan–Meier estimated cumulative incidence calculation for each.
Rupture rate, suspected and confirmed, for primary augmentation was 1.1% (95% CI, 0.3–4.3), and that for primary reconstruction patients was 3.8% (95% CI, 1.4–9.8). Capsular contracture rates for clinically significant Baker III/IV contracture for primary augmentation was 9.8% (95% C I, 7.6–12.7), and that for primary reconstruction was 13.7% (95% CI, 9.7–19.1). The reoperation incidence for primary augmentation and primary reconstruction was 19.4 and 33.9%, respectively, with explantation and replacement with a study device in 3.9% of primary augmentations and 10.4% of primary reconstructions.
Mentor MemoryGel Silicone Breast implants represent a safe and effective choice for women seeking breast augmentation or breast reconstruction following mastectomy.
KeywordsMentor Silicone breast implants Safety Effectiveness Outcomes Follow-up Rupture Complications
- 1.Transcript of the FDA Panel, Mentor hearings (April 2005). Available at http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4101t3.doc. Accessed 6 May 2009
- 2.FDA Summary Panel Memorandum: Mentor P030053. Available at http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_Tab-1_fda-Mentor%20Panel%20Memo.pdf. Accessed 6 May 2009