NCT00756652: MGPAS

Mentor MemoryGel Post-Approval Study

Completed Results posted Last updated 4 June 2020

What this trial tests

trial testing Mentor Silicone Gel-Filled Breast Implants in Breast Reconstruction in 42,491 participants. Completed in 31 July 2019.

Timeline

1 November 2006

Primary endpoint
31 July 2019

31 July 2019

Quick facts

Lead sponsor	Mentor Worldwide, LLC
Status	Completed
Study type	OBSERVATIONAL
Enrollment	42,491
Start date	1 November 2006
Primary completion	31 July 2019
Estimated completion	31 July 2019

Drugs / interventions tested

• Mentor Silicone Gel-Filled Breast Implants
• Saline Breast Implants

Conditions studied

• Breast Reconstruction — all drugs for Breast Reconstruction →
• Breast Augmentation — all drugs for Breast Augmentation →
• Breast Revision — all drugs for Breast Revision →

Sponsor

Mentor Worldwide, LLC — full company profile →

Who can join

18 and older, female only, with Breast Reconstruction or Breast Augmentation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Kaplan Meier Estimated Cumulative Incidence of Reported Complications Primary · 10 years

The KM estimated cumulative incidence of reoperation and explantation has been estimated on a patient-level basis. The data for the KM analysis used the follow-up and reoperation/explantation reports from the entire data set of the 41,452 participants in the Original study, with follow-up and additional reoperartions/explantations reported on the 11,101 participants in the ReOperation phase. Participants with no post-op follow-up are excluded from the KM analysis.

0 Years

Group	Value	95% CI
MemoryGel Participants	0.0	0 – 0

1 Year

Group	Value	95% CI
MemoryGel Participants	6.7	6.2 – 7.2

2 Years

Group	Value	95% CI
MemoryGel Participants	10.8	10.1 – 11.4

3 Years

Group	Value	95% CI
MemoryGel Participants	11.2	10.5 – 11.8

4 Years

Group	Value	95% CI
MemoryGel Participants	11.7	11.0 – 12.4

5 Years

Group	Value	95% CI
MemoryGel Participants	12.5	11.8 – 13.2

6 Years

Group	Value	95% CI
MemoryGel Participants	13.0	12.3 – 13.8

7 Years

Group	Value	95% CI
MemoryGel Participants	13.2	12.5 – 14.0

Kaplan Meier Estimated Cumulative Incidence of Explantation Primary · 10 years

The KM estimated cumulative incidence of reoperation and explantation has been estimated on a patient-level basis. The data for the KM analysis used the follow-up and reoperation/explantation reports from the entire data set of the 41,452 participants in the Original study, with follow-up and additional reoperartions/explantations reported on the 11,101 participants in the ReOperation phase. Participants with no post-op follow-up are excluded from the KM analysis.

0 Years

Group	Value	95% CI
MemoryGel Participants	0	0 – 0

1 Year

Group	Value	95% CI
MemoryGel Participants	3.0	2.7 – 3.4

2 Years

Group	Value	95% CI
MemoryGel Participants	5.0	4.6 – 5.5

3 Years

Group	Value	95% CI
MemoryGel Participants	5.2	4.7 – 5.7

4 Years

Group	Value	95% CI
MemoryGel Participants	5.5	5.0 – 6.1

5 Years

Group	Value	95% CI
MemoryGel Participants	6.0	5.4 – 6.5

6 Years

Group	Value	95% CI
MemoryGel Participants	6.4	5.8 – 6.9

7 Years

Group	Value	95% CI
MemoryGel Participants	6.5	6.0 – 7.1

Reasons for Reoperations Secondary · 10 Years

Frequencies of the reason for reoperation will be computed for women with MemoryGel breast implants through 10 years

Asymmetry

Group	Value	95% CI
MemoryGel Participants	465

Biopsy

Group	Value	95% CI
MemoryGel Participants	17

Breast - unacceptably high sensation

Group	Value	95% CI
MemoryGel Participants	2

Breast pain not associated with other complication

Group	Value	95% CI
MemoryGel Participants	26

Calcification

Group	Value	95% CI
MemoryGel Participants	1

Capsular Contracture (Baker Grade II)

Group	Value	95% CI
MemoryGel Participants	238

Capsular Contracture (Baker Grade III)

Group	Value	95% CI
MemoryGel Participants	423

Capsular Contracture (Baker Grade IV)

Group	Value	95% CI
MemoryGel Participants	224

Sponsor's own description

In November 2006, U.S. Food and Drug Administration (FDA) approved Mentor's MemoryGel silicone gel-filled breast implants for use in women who are undergoing primary or revisional breast augmentation and primary or revisional breast reconstruction surgery. This postapproval study is intended to satisfy one element of FDA's postapproval monitoring requirements. In January 2015, the FDA approved a protocol amendment that limits the scope of data collection for the study to the collection of only secondary procedure/reoperation data for MemoryGel participants.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Results from the MemoryGel Post-approval Study.
   Short KK, Wixtrom RN, Estes MM, Leopold J, et al · · 2021 · cited 3× · PMID 33786254 · DOI 10.1097/gox.0000000000003402
2. Three-Dimensional Disassemblable Scaffolds for Breast Reconstruction.
   Kiseleva V, Bagdasarian A, Vishnyakova P, Elchaninov A, et al · · 2025 · PMID 40808084 · DOI 10.3390/polym17152036