BTS -Program

Real-World Evidence Shows Low Rupture Rates of MENTOR ® MemoryGel ® Breast Implants

Mentor global complaint rates and post-approval study report long-term low rupture ra

Mentor global complaint rates and post-approval study report long-term low rupture rates

Mentor Global Rupture Complaint Rate 1 (over 16 years ) a

6 M+ IMPLANTS

0.6 %

MemoryGel devices used for Augmentation and Reconstruction

MemoryGel ® Post-Approval Study Reoperations Due to Rupture b,2 (over 10 years )

700 U.S. CENTERS c

~ 6,700 PATIENTS c

0.8 %

MemoryGel devices used for Primary Augmentation

Latest independent research with high resolution ultrasound (HRUS) consistently $ +($É+( +Êł È É d,3 (implanted up to 20 years ) e

9 U.S. CENTERS

608 IMPLANTS e

9 U.S. CENTERS

608 IMPLANTS e

6.5 %

MemoryGel and MemoryShape ® Breast Implants used for Augmentation and Reconstruction

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$$ ÊÈ Ç+ÊÇ + É+Ê( (É$ÈÊłÈÉ$ É & +$+ + É+Ê c Number of patients and centers that participated in the re-operation phase of the study; overall, 74.1% of women in the re-operation phase completed their 10 year follow-up. Among these ~6,700 patients, 944 women underwent 1,748 total re-operations, of which rupture was the primary reason for 14 of those re-operations. d 8.7% (53/608) of MENTOR Implants were evaluated as suspected ruptures based on HRUS. For the entire study cohort, 82 women had suspected ruptures, 40 of whom were explanted. Upon explantation, 25% of the suspected ruptures were found intact, giving a 25% false-positivity to the HRUS detection accuracy. This calculation assumes that the 25% false positivity was evenly distributed across different manufacturers’ devices and would persist if the remaining 42 women were explanted and that there would be no false negatives. e Including MemoryGel and MemoryShape Breast Implants implanted between Jan 2000 and Dec 2015, HRUS performed between April 2019 and March 2020. a MENTOR® MemoryGel Complaint Data stats: U.S. from Jan 2006 through Dec 2021, EMEA/ LATAM / Canada/ APAC from Jan 2011 through Dec 2021. b : Ê+ É$$ 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 w 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% 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’ dev 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. WARNING: • Breast implants are not considered lifetime devices. The longer people have them, the greater the chances are that they will develop complications, some of which will require more surgery. • Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma Z15-c-ABA[D $ ÉÊ + $+ ++Ê&ÊÉÊ$( ) È É$ÉÊ$ ÉÊ$++ ÉÊ$É + Ç É$É Ê+(ÈłÊÈh+ patients have died from BIA-ALCL. • Patients receiving breast implants have reported a variety of systemic symptoms such as joint pain, muscle aches, confusion, chronic fatigue, autoimmune diseases and others. Individual patient risk for developing these symptoms has not been well established. Some patients report complete resolution of symptoms when the implants are removed without replacement. • Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lym Z15-c-ABA[D $ ÉÊ + $+ ++Ê&ÊÉÊ$( ) È É$ÉÊ$ ÉÊ$++ ÉÊ$É + Ç É$É Ê+(ÈłÊÈh+ patients have died from BIA-ALCL. • Patients receiving breast implants have reported a variety of systemic symptoms such as joint pain, muscle aches, confusion, chronic fatigue, autoimmun diseases and others. Individual patient risk for developing these symptoms has not been well established. Some patients report complete resolution of sym when the implants are removed without replacement. WARNING: • Breast implants are not considered lifetime devices. The longer people have them, the greater the chances are that they will develop complications, some will require more surgery.

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