Real-World Evidence Shows Low Rupture Rates of MENTOR ® MemoryGel ® Breast Implants
World Evidence Shows Low Rupture Rates of NTOR ® MemoryGel ® Breast Implants
Summary of Real-World Evidence
y of Real-World Evidence
Global Complaint Analysis Mentor Complaints Analysis 1
Global Complaint Analysis Mentor Complaints Analysis 1 Source
Multicenter Studies
Single Center Studies
Multicenter Studies
Single Center Studies
Salzman 3P Short 2P (MemoryGel Post-Approval Study)
Short 2P (MemoryGel Post-Approval Study)
Salzman 3P
Maxwell 4R
Collis 5P
Maxwell 4R
Collis 5P
urce
0.6%
0.8%
6.5%
1.6%
11.8%
0.6%
0.8%
6.5%
1.6%
11.8%
Rate
ate
Type of Rate
B+Êł È;
Re-ops Due to Rupture b
B+Êł È d Rupture
B+Êł È;
B+Êł È;
of Rate
B+Êł È;
Re-ops Due to Rupture b
B+Êł È d Rupture
B+Êł È;
B+Êł È;
Multicenter (>700 in Re-op phase c ) ~6,700 Patients in Re-op Phase c
Multicenter (>700 in Re-op phase c ) ~6,700 Patients in Re-op Phase c N/A
Centers
Multicenter (9)
Single
Single
nters
N/A
Multicenter (9)
Single
Single
608 Implants e
191 Patients
149 Patients
Sample Size
6 Million+ Implants
608 Implants e
191 Patients
149 Patients
le Size
6 Million+ Implants
Augmentation and Reconstruction
Augmentation and Reconstruction
Augmentation and Reconstruction Cohort(s)
Augmentation and Reconstruction
Primary Augmentation
Primary Augmentation Primary Augmentation
ort(s)
Primary Augmentation
Primary Augmentation Primary Augmentation
10 Years
13 Years
N/A Duration of Follow-up
N/A
10 Years
Up to 20 Years e
10 Years
13 Years
f Follow-up
10 Years
Up to 20 Years e
2007-2019
2000-2020
~1990s to Early 2000s 2006-2019
~1990s to Early 2000s
Study Timeframe
2006-2021 a
2007-2019
2000-2020
2006-2019
meframe
2006-2021 a
Implant Patient or Implant Level Rate
mplant Level ate
Implant
Patient
Implant
Patient
Implant
Patient
Implant
Patient
Implant
No Scheduled Imaging?
No
No
HRUS
No
MRI
d Imaging?
No
HRUS
No
MRI
Where Conducted?
Worldwide
U.S.
U.S.
U.S.
UK
onducted?
Worldwide
U.S.
U.S.
U.S.
UK
MemoryGel, MemoryShape
MemoryGel, MemoryShape
MemoryGel ® SILTEX only
Devices
MemoryGel
MemoryGel
MemoryGel ® SILTEX only
vices
MemoryGel
MemoryGel
MemoryGel
P = prospective study, R = retrospective study
study, R = retrospective study
a is passively collected through an internal system and cannot be determined from this reporting system alone due to potential under-reporting, duplicate reporting of events, and the lack of ,foȗeöljļŞƌAöī ŞöÎŤūJljśīÎijūŤÎŞöéÎêĨöðéƌÎċŞööīĕċöūĕljöśŞļðŰêūŞöśīÎêöljöijūśļīĕêƌūĒÎūŞöŝŰĕŞöŤūĒöśÎūĕöijūūļŞöśļŞūĕijêĕðöijêöļċŞŰśūŰŞöĕijļŞðöŞūļéöijöƞūċŞļljūĒöśļīĕêƌǂĒļŞū REFERENCES 1. Complaint data is passively collected through an internal system and cannot be determined from this reporting system alone due to potential under-reporting, duplicate reporting of events, and the lack of ĕijċļŞljÎūĕļijǂe,foȗeöljļŞƌAöī ŞöÎŤūJljśīÎijūŤÎŞöéÎêĨöðéƌÎċŞööīĕċöūĕljöśŞļðŰêūŞöśīÎêöljöijūśļīĕêƌūĒÎūŞöŝŰĕŞöŤūĒöśÎūĕöijūūļŞöśļŞūĕijêĕðöijêöļċŞŰśūŰŞöĕijļŞðöŞūļéöijöƞūċŞļljūĒöśļīĕêƌǂĒļŞū ts from the MemoryGel Post-approval Study Plast Reconstr Surg Glob Open. 2021 Mar 26;9(3):e3402. Results from the MemoryGel Post-approval Study. Plast Reconstr Surg Glob Open. 2021 Mar 26;9(3):e3402. KK, et al. Results from the MemoryGel Post-approval Study Plast Reconstr Surg Glob Open. 2021 Mar 26;9(3):e3402. 2. Short KK, et al. Results from the MemoryGel Post-approval Study. Plast Reconstr Surg Glob Open. 2021 Mar 26;9(3):e3402. lent Rupture of Silicone Gel Breast Implants: High-Resolution Ultrasound Scans and Surveys of 584 Women. Plast Reconstr Surg. 2022 Jan 1;149(1):7-14. ÎīǂÎċöūƌÎijð,ƙöêūĕƅöijöŤŤļċĕīĕêļijöAöīǔ@ĕīīöð ŞöÎŤūJljśīÎijūŤĕijŞĕljÎŞƌŰČljöijūÎūĕļijÎūĕöijūŤǂöŤūĒöūŰŞČYǂƧƥƧƦeÎƌƦƭLJƩƦǐƫǑƼfƨƧƮǔfƨƨƪǂ Magnetic resonance imaging and explantation investigation of long-term silicone gel implant integrity. Plast Reconstr Surg. 2007 Oct;120(5):MG 1401-1406. 3. Salzman MJ. Silent Rupture of Silicone Gel Breast Implants: High-Resolution Ultrasound Scans and Surveys of 584 Women. Plast Reconstr Surg. 2022 Jan 1;149(1):7-14. 4. eÎƋƆöīī&ƽöūÎīǂÎċöūƌÎijð,ƙöêūĕƅöijöŤŤļċĕīĕêļijöAöīǔ@ĕīīöð ŞöÎŤūJljśīÎijūŤĕijŞĕljÎŞƌŰČljöijūÎūĕļijÎūĕöijūŤǂöŤūĒöūŰŞČYǂƧƥƧƦeÎƌƦƭLJƩƦǐƫǑƼfƨƧƮǔfƨƨƪǂ 5. Collis N, et al. Magnetic resonance imaging and explantation investigation of long-term silicone gel implant integrity. Plast Reconstr Surg. 2007 Oct;120(5):MG 1401-1406. ation: ŞĕļŞūļŰŤöƽŞöċöŞūļūĒöĕijŤūŞŰêūĕļijŤċļŞŰŤöŤŰśśīĕöðƆĕūĒūĒĕŤðöƅĕêöċļŞĕijðĕêÎūĕļijŤƽêļijūŞÎĕijðĕêÎūĕļijŤƽŤĕðööƙöêūŤƽƆÎŞijĕijČŤÎijðśŞöêÎŰūĕļijŤǂ restricts this device to sale by or on the order of a physician. Information: MENTOR® MemoryGel® Breast Implants are indicated for breast augmentation in women at least 22 years old or for breast reconstruction. Breast should not be performed in women with active infection anywhere in their body with existing cancer or pre-cancer of their breast who have not received adequate ose conditions or are pregnant or nursing. Breast implants are not lifetime devices and breast implantation is not necessarily a one-time surgery. The chance of plications increases over time. The most common complications with the MemoryGel® Breast Implants include reoperation, capsular contracture, asymmetry, and ƆöŞŞĕŤĨļċêļljśīĕêÎūĕļijĕŤŞŰśūŰŞöǂĒöĒöÎīūĒêļijŤöŝŰöijêöŤļċÎŞŰśūŰŞöðŤĕīĕêļijöČöīǔƞīīöðéŞöÎŤūĕljśīÎijūĒÎƅöijļūéööijċŰīīƌöŤūÎéīĕŤĒöðǂeJŤêŞööijĕijČŤÎŞö hree years after initial implant surgery and then every two years after to detect silent rupture. Breast implants are also associated with the risk of breast implant- lastic large cell lymphoma (BIA-ALCL), an uncommon type of lymphoma. An individual’s risk of developing BIA-ALCL with MENTOR® Breast Implants is low ĕðöijêöļċƆļŞīðƆĕðöêÎŤöŤǂÎūĕöijūŤŤĒļŰīðŞöêöĕƅöÎêļśƌļċJljśļŞūÎijūJijċļŞljÎūĕļijċļŞŰČljöijūÎūĕļijÎūĕöijūŤÎéļŰūe,foȗeöljļŞƌAöīȗĕīĕêļijöAöīǔ@ĕīīöð ļŞJljśļŞūÎijūJijċļŞljÎūĕļijċļŞöêļijŤūŞŰêūĕļijÎūĕöijūŤÎéļŰūe,foȗeöljļŞƌAöīȗĕīĕêļijöAöīǔ@ĕīīöð ŞöÎŤūJljśīÎijūŤǂÁļŰŞśÎūĕöijūijööðŤūļŞöÎðÎijðŰijðöŞŤūÎijð ŞöČÎŞðĕijČūĒöŞĕŤĨŤÎijðéöijöƞūŤļċéŞöÎŤūĕljśīÎijūŤƽƆĕūĒÎijļśśļŞūŰijĕūƌūļêļijŤŰīūƆĕūĒƌļŰśŞĕļŞūļðöêĕðĕijČļijŤŰŞČöŞƌǂ@ļŞðöūÎĕīöðĕijðĕêÎūĕļijŤƽêļijūŞÎĕijðĕêÎūĕļijŤƽ êÎŰūĕļijŤÎŤŤļêĕÎūöðƆĕūĒūĒöŰŤöļċeöljļŞƌAöīȗ ŞöÎŤūJljśīÎijūŤǂīöÎŤöŞöċöŞūļūĒöJijŤūŞŰêūĕļijŤċļޤŤöǐJ@¤ǑśŞļƅĕðöðƆĕūĒöÎêĒśŞļðŰêūƽļŞļijīĕijöÎūƆƆƆǂ m. Important Safety Information: MENTOR® MemoryGel® Breast Implants are indicated for breast augmentation in women at least 22 years old or for breast reconstruction. Breast implant surgery should not be performed in women with active infection anywhere in their body with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions or are pregnant or nursing. Breast implants are not lifetime devices and breast implantation is not necessarily a one-time surgery. The chance of developing complications increases over time. The most common complications with the MemoryGel® Breast Implants include reoperation, capsular contracture, asymmetry, and éŞöÎŤūśÎĕijǂīļƆöŞŞĕŤĨļċêļljśīĕêÎūĕļijĕŤŞŰśūŰŞöǂĒöĒöÎīūĒêļijŤöŝŰöijêöŤļċÎŞŰśūŰŞöðŤĕīĕêļijöČöīǔƞīīöðéŞöÎŤūĕljśīÎijūĒÎƅöijļūéööijċŰīīƌöŤūÎéīĕŤĒöðǂeJŤêŞööijĕijČŤÎŞö recommended three years after initial implant surgery and then every two years after to detect silent rupture. Breast implants are also associated with the risk of breast implant- associated anaplastic large cell lymphoma (BIA-ALCL), an uncommon type of lymphoma. An individual’s risk of developing BIA-ALCL with MENTOR® Breast Implants is low éÎŤöðļijūĒöĕijêĕðöijêöļċƆļŞīðƆĕðöêÎŤöŤǂÎūĕöijūŤŤĒļŰīðŞöêöĕƅöÎêļśƌļċJljśļŞūÎijūJijċļŞljÎūĕļijċļŞŰČljöijūÎūĕļijÎūĕöijūŤÎéļŰūe,foȗeöljļŞƌAöīȗĕīĕêļijöAöīǔ@ĕīīöð ŞöÎŤūJljśīÎijūŤļŞJljśļŞūÎijūJijċļŞljÎūĕļijċļŞöêļijŤūŞŰêūĕļijÎūĕöijūŤÎéļŰūe,foȗeöljļŞƌAöīȗĕīĕêļijöAöīǔ@ĕīīöð ŞöÎŤūJljśīÎijūŤǂÁļŰŞśÎūĕöijūijööðŤūļŞöÎðÎijðŰijðöŞŤūÎijð ūĒöĕijċļŞljÎūĕļijŞöČÎŞðĕijČūĒöŞĕŤĨŤÎijðéöijöƞūŤļċéŞöÎŤūĕljśīÎijūŤƽƆĕūĒÎijļśśļŞūŰijĕūƌūļêļijŤŰīūƆĕūĒƌļŰśŞĕļŞūļðöêĕðĕijČļijŤŰŞČöŞƌǂ@ļŞðöūÎĕīöðĕijðĕêÎūĕļijŤƽêļijūŞÎĕijðĕêÎūĕļijŤƽ ƆÎŞijĕijČÎijðśŞöêÎŰūĕļijŤÎŤŤļêĕÎūöðƆĕūĒūĒöŰŤöļċeöljļŞƌAöīȗ ŞöÎŤūJljśīÎijūŤǂīöÎŤöŞöċöŞūļūĒöJijŤūŞŰêūĕļijŤċļޤŤöǐJ@¤ǑśŞļƅĕðöðƆĕūĒöÎêĒśŞļðŰêūƽļŞļijīĕijöÎūƆƆƆǂ mentorwwllc.com. Important information: ŞĕļŞūļŰŤöƽŞöċöŞūļūĒöĕijŤūŞŰêūĕļijŤċļŞŰŤöŤŰśśīĕöðƆĕūĒūĒĕŤðöƅĕêöċļŞĕijðĕêÎūĕļijŤƽêļijūŞÎĕijðĕêÎūĕļijŤƽŤĕðööƙöêūŤƽƆÎŞijĕijČŤÎijðśŞöêÎŰūĕļijŤǂ Caution: US law restricts this device to sale by or on the order of a physician. moryGel Complaint Data stats: U.S. from Jan 2006 through Dec 2021, EMEA/ LATAM / Canada/ APAC from Jan 2011 through Dec 2021. ÊÈ Ç+ÊÇ + É+Ê( (É$ÈÊłÈÉ$ É & +$+ + É+Ê ts and centers that participated in the re-operation phase of the study; overall, 74.1% of women in the re-operation phase completed their 10 year follow-up. Among these ~6,700 patients, 944 women otal re-operations, of which rupture was the primary reason for 14 of those re-operations. MENTOR Implants were evaluated as suspected ruptures based on HRUS. For the entire study cohort, 82 women had suspected ruptures, 40 of whom were explanted. Upon explantation, 25% of the s were found intact, giving a 25% false-positivity to the HRUS detection accuracy. This calculation assumes that the 25% false positivity was evenly distributed across different manufacturers’ devices and would ining 42 women were explanted and that there would be no false negatives. Gel and MemoryShape Breast Implants implanted between Jan 2000 and Dec 2015, HRUS performed between April 2019 and March 2020. a MENTOR® MemoryGel Complaint Data stats: U.S. from Jan 2006 through Dec 2021, EMEA/ LATAM / Canada/ APAC from Jan 2011 through Dec 2021. b : Ê+ É$$ ÊÈ Ç+ÊÇ + É+Ê( (É$ÈÊłÈÉ$ É & +$+ + É+Ê c Number of patients and centers that participated in the re-operation phase of the study; overall, 74.1% of women in the re-operation phase completed their 10 year follow-up. Among these ~6,700 patients, 944 women underwent 1,748 total re-operations, of which rupture was the primary reason for 14 of those re-operations. d 8.7% (53/608) of MENTOR Implants were evaluated as suspected ruptures based on HRUS. For the entire study cohort, 82 women had suspected ruptures, 40 of whom were explanted. Upon explantation, 25% of the suspected ruptures were found intact, giving a 25% false-positivity to the HRUS detection accuracy. This calculation assumes that the 25% false positivity was evenly distributed across different manufacturers’ devices and would persist if the remaining 42 women were explanted and that there would be no false negatives. e Including MemoryGel and MemoryShape Breast Implants implanted between Jan 2000 and Dec 2015, HRUS performed between April 2019 and March 2020.
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wide LLC 2022 211347-220706
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