Capsular Contracture

After your breast implant surgery, your breasts will begin to heal and adapt to the presence of the breast implants. A regular part of this process is that the breast tissue typically forms an internal scar immediately surrounding the implant. In many cases, this tissue forms a capsule that helps hold the implant in place. However, in some women, in some women, the scar tissue around the implant tightens and squeezes the implant. When scar tissue squeezes an implant, it is called capsular contracture. There are four grades of capsular contracture - Baker Grades I through IV, and surgical treatment is typically recommended for Grades III and IV.

Capsular contracture causes the breast to feel abnormally firm and can cause pain. The chances of having contracture typically increase the longer you have your implants. Capsular contracture is a risk factor for implant rupture, and it is one of the most common reasons for reoperation.

The estimated risk of augmentation patients* experiencing Baker Grade III/IV capsular contracture based on our 10-year studies are:

• 12% through 10 years for MemoryGel™ Breast Implants ¹
• 18.8% through 10 years for Saline Breast Implants ²
• 3.8% through 10 years for MemoryShape™ Breast Implants ^†

Long-term clinical data support lower capsular contracture rates with the use of MENTOR™ SILTEX™ Microtextured breast implants compared to Mentor smooth implants in augmentation patients.³

*Data from the primary augmentation cohort of our 10-year studies.

†Not a head to head study.Based on the comparison of key complication rates reported in the 10 year Core Studies for MemoryShape™/CPG™ Gel Breast Implants, NATRELLE™ 410 TruForm™ Gel Breast Implants, NATRELLE™ Round TruForm™ Gel Breast Implants, and MemoryGel™ Breast Implants.

Rupture or Deflation

Breast implants are considered ruptured when a gel implant shell develops a tear or hole. When a saline-filled implant shell develops a tear or hole, it is considered a deflation or leak because the saline solution will be released from implant Your breast implants could rupture or leak for several reasons, including: damage by surgical instruments at the time surgery, stress to the implant during surgery that weakens it, excessive force to the chest, trauma, compression during a mammogram, or normal use over time.

Implants could rupture or deflate at any time after your implant surgery, but the longer the implants are in place, the higher the possibility that the implants will rupture or leak.

In our 10-year study, the overall occurrence of rupture* among augmentation patients was:

• 9.8% for MemoryGel™ Breast Implants ¹
• 3.3% for MemoryShape™ Breast Implants ⁴

An analysis was also done to try and estimate the probability of a rupture or deflation by a specified years after surgery using the Kaplan-Meier method. This method attempts to account for patients not returning for follow-up and adjusts the estimated rupture or deflation rate accordingly. Kaplan-Meier estimated rupture rate at 10 years was 24% for MemoryGel™ Breast Implants and 7% for MemoryShape™ Breast Implants.

The accuracy of the Kaplan-Meier estimate for Mentor ruptures is limited by the low follow-up rates observed across all cohorts of the MRI sub-study at 10 years, as well as competing risks such as device removal for reasons other than rupture.

Mentor advises surgeons and their patients to have MRI screening for silent rupture 3 years after implantation and every 2 years, thereafter. This guidance allows for early detection and timely removal of ruptured devices in asymptomatic patients.

*Data from primary augmentation cohort (1st and 2nd MRI Cohort pooled).

**The MemoryShape™ and MemoryGel™ data was from the primary augmentation cohort (1st MRI Cohort).