Allergan/Inamed Natrelle Silicone-Filled Breast Implants:

Allergan’s Natrelle Post-Approval Studies (6):

The Approval Order requested six Post-Approval Studies as conditions of FDA approval. The FDA states, “Post-approval studies (PAS) are conditions of device approval. A sponsor’s failure to comply with any post-approval requirement may be grounds for withdrawing approval.” Source.

Core StudyThe overall follow-up rate was 65% at 10 years. The FDA had required this study to be done for 10 years, according to guidelines of the Approval Order in 2006, but the Final Report was submitted in year 5 of the study in 2011.

Large Study – “BIFS”The follow-up rates for this study are not listed.  The intent of this study was to follow women for 10 years, commencing 90 days from the protocol was submitted to the FDA on October 16th, 2006. In 2015 the original Large Study has been restructured into a “ReOp” Study, see below.

Adjunct StudyThe overall follow-up rate was 16.8% at 5 years. Adjunct studies are the post-market continued follow-up of what began as the pre-market studies, so that the pre-market enrolled patients can complete their five year follow-up evaluations. This study enrolled patients from 1998-Nov 2006 (when the device was approved), it followed reconstruction and revision patients for five years.

Focus Study: This study used 52 women to evaluate how patients understood the safety and labeling brochures.

Informed Study: A random selection of 50 breast surgeons was used for each year for 5 years to assess the efficiency of their Informed Consent process. The Approval Order required an independent group. Overall, this study seemed self-serving to the physicians who are ironically the ones conducting the study on their patients. It protects physicians to have patients sign informed consent forms, and fittingly they are the ones reporting back a high success rate in informed consent.

Device Failure Study: “70 devices used in the Core Allergan study were returned to the Device Failure Laboratory. 35.7% of these returned devices from the Core had an unidentified opening (10% with surgical damage). There were 26 devices from the Large Post Approval study that have been returned. Of these, 17 (65%) had failure modes associated with surgical damage. The total number of all devices returned from the start of the study (July 31, 2000) until the time of the report date cutoff (June 30, 2009) totaled 2,665 (this includes those from the Core and those from the BIFS). Surgical damage was the leading cause of failure at 17% among all devices. The devices retrieved from the Large post-approval study are potentially experiencing surgical damage at a higher rate, but this has not been statistically confirmed.”

In 2011 there was an update on the findings (Update on the Safety of Silicone Gel-Filled Breast Implants).

The above were the original six post-approval studies required by the Approval Order. Currently, there are two new studies underway and both started in 2015. The original Large Study was restructured into the “Re-Op Study”and there has been the addition of the “Natrelle and Natrelle 410 Anatomical Combined Study” and a “Case-Control Study.”

Re-Op Study: Patients enrolled in the Re-Op Phase of the BIFS (Large Post-Approval Study) will be followed for data collection during reoperation events.

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 StudyTerminated. 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).

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.