Allergan Natrelle Saline Breast Implants:
- Date of Approval: May 10th, 2000 (McGhan Saline-Filled Breast Implant)
- Recalls: McGhan Recalls.
- Medical Device Recall Search
- FDA Overview – Saline Breast Implants
- FDA PMA P990074 and FDA PMA Related Links
- Approval Order (Post-Approval Study Conditions)
- Summary of Safety & Effectiveness (Heavy Metals, pg. 6)
- Labeling Pamphlet (from May 5th, 2000 as McGhan)
- Labeling Pamphlet #1 (for patients, from 2004 as Inamed)
- Labeling Pamphlet #2 (for physicians, from 2009 as Allergan)
- Supplements: S001, S002, S003, S004, S005, *S006, **S007, S008, S009, S010, S011, *S012, S013, *S014, *S015, S016, S017, **S018, S019, *S020, *S021, S022, **S023, S024, S025, S026, S027, **S028, S029, S030, *S031, S032, **S033, S034, S035
- Note: Allergan acquired Inamed in 2006. On May 17, 2007 there was a name change from Inamed to Natrelle in the labeling of the Natrelle saline implants.
Allergan Saline Post-Approval Studies:
- A 10-year post-approval study to assess the long-term clinical performance of the device. All patients enrolled in the 1995 Studies will be asked to enroll in this post-approval study. Safety data such as reoperations, deflation, capsular contracture, and pain will be collected annually out to 10 years for each patient.
- Retrieval study to collect visual examination, physical, and histological data on explanted implants to determine the mode of failure of implants.
- Focus-group study to obtain immediate feedback on the patient informed decision brochure from both augmentation and reconstruction patients. This will involve obtaining responses from patients on the patient labeling format and content, generating a report of the findings, and incorporating all appropriate revisions immediately.
- Mechanical testing (i.e., fatigue rupture and shelf-lfie).
A search has been done in the FDA post-approval study database for P990074 but no search results appeared. 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]s.gov and phone number is (301) 796-6134.
For a timeline of Allergan Natrelle Saline Breast Implants, click here.