The Mentor Study on Contour Profile Gel Silicone MemoryGel Breast Implants
Bibliographic record
Abstract
BACKGROUND: Two-year safety and efficacy data were presented to the Canadian Therapeutic Products Directorate Scientific Advisory Panel, in Ottawa, Ontario, Canada. METHODS: The 955 women enrolled in the 10-year, multicenter, Mentor MemoryGel study were distributed into four cohorts: 572 augmentation patients, 123 revision-augmentation patients, 191 reconstruction patients, and 69 revision-reconstruction patients. The surgeons in the study received an intensive clinical educational program in addition to the protocol. RESULTS: Mentor's 2-year study results indicate that the risk of any complication or reoperation at some point through 2 years after implant surgery is 24.5 percent for primary augmentation patients, 30.2 percent for revision-augmentation patients, 42.9 percent for primary reconstruction patients, and 41.8 percent for revision-reconstruction patients. The rupture rates reported from the magnetic resonance imaging cohort were 0 percent for all groups. Patients reoperated on at least one time were as follows: 9.4 percent for primary augmentation, 12.8 percent for revision-augmentation, 27.3 percent for primary reconstruction, and 19.4 percent for revision-reconstruction. Also, 2.4 percent of primary augmentation patients, 7.3 percent of revision-augmentation patients, 8.9 percent of primary, and 11.6 percent of reconstruction patients had their implants removed, with patient choice and capsular contracture being the most common reasons. CONCLUSIONS: The data from the Mentor CPG Gel Study resulted in approval of these implants for general use on October 20, 2006. The educational program resulted in improved clinical outcomes and probably should be required for all surgeons using the devices.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.000 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".