Allergan Natrelle 410 Highly Cohesive Anatomical Shaped Silicone-Filled Breast Implants:
- Date of Approval: Feb. 20th, 2013
- Medical Device Recall Search
- FDA Overview – Natrelle 410 Anatomical
- Consumer Information
- FDA PMA P040046
- Approval Order (Post-Approval Study Conditions)
- Summary of Safety & Effectiveness (Heavy Metals, pgs. 9-10)
- Labeling Pamphlet #1 (for augmentation, from 2013)
- Labeling Pamphlet #2 (for reconstruction, from 2013)
- Labeling Pamphlet #3 (mini brochure, from 2013)
- Labeling Pamphlet #4 (for physicians, from 2013)
- Supplements: S001, S002, S003, S004, S005, S006, S007, *S008, *S009, S011, S012, *So13, S014, S015, S016, **S017, S018
Allergan’s Natrelle 410 Cohesive Anatomical Post-Approval Studies (5):
Natrelle and 410 Anatomical Combined Study: Intended to observe Allergan’s two breast implant devices, Natrelle and Natrelle 410 Anatomical, for 10 years.
Case-Control Study: Terminated. The purpose was to evaluate the association between Allergan Natrelle 410 Cohesive Anatomical Silicone Breast Implants and five rare disease outcomes: rare connective tissue diseases, neurological diseases, brain cancer, cervical/vulvar cancer and lymphoma. This study was to be conducted in the the UK.
Case-control studies were later terminated after the release of Tufts’s evidence report. In 2013 American Society of Plastic Surgeons (ASPS) commissioned a systematic literature review to be conducted by Tufts Center for Clinical Evidence Synthesis, funded by three breast implant sponsors, and the advisory board approved the final report on 8/1/2014. (The alarming conflict of interest in the manufacturers sponsoring the studies and in the plastic surgeons handling the study is astounding).
Continued Access Study: The overall follow-up was 55% at 5 years. The overall MRI follow-up was 58.3%. This study was to continue follow-up for up to 5 years post implantation of patients who received Allergan’s 410 Cohesive Anatomical Silicone Breast Implants prior to approval but outside of the Core Study. The final report was in 2015.
Core Study: The overall follow-up was 66% at 10 years. This was a 10 year premarket study where the last patient was enrolled on February 28, 2002. As part of approval, Allregan had to submit the final report of this premarket study and list it as a postmarket study.
Focus Group Study: This study used 45 women to evaluate how patients understood the safety and labeling brochures. Some respondents suggested that the true purpose of the brochure was to protect Mentor, rather than inform patients about breast implant surgery.
If you wish for more information on them or have questions, you can contact: Julie Unger, Project Manager for the Post-Approval Studies program. Her email is [email protected] and phone number is (301) 796-6134.
For a timeline of Allergen silicone breast implants, click here.