Purpose: Since their introduction in 1993, the Style 410 highly cohesive silicone gel breast implants have become the gold standard of shaped implants in countries where they are available. This next generation implant has a more crosslinked silicone gel filler than standard responsive gel implants and is designed to hold its shape even when the shell is not intact.

Methods: Safety and effectiveness of Style 410 implants are being evaluated through a prospective study conducted by 48 investigators throughout the US. Follow-up exams occurred between 0-4 weeks, at 6 months and then annually, with results currently available through 4 years. Complications, reoperation rates and implant removal/replacements were assessed in addition to patient satisfaction.

Results: The 410 pivotal study enrolled 941 subjects: 492 primary augmentation, 225 reconstruction, 156 revision augmentation and 68 revision reconstruction patients. Complication rates were consistent with or better than those reported for responsive Inamed^® silicone-filled breast implants. Patient satisfaction rates were uniformly high, with more than 85% in each cohort expressing satisfaction with their implants.

Conclusion: The study results address safety and effectiveness endpoints for the Style 410 highly cohesive silicone-filled breast implants with 4 years of follow-up.