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As with any medical device, there are risks involved with breast implants. The most common complications associated with breast implants are reoperation, capsular contracture, implant removal, and rupture.
Following your breast surgery, it’s important that you have regular follow up exams and follow your doctor’s instructions to monitor your breast implants. If you notice any changes to your breast implants or experience any unusual signs or symptoms of health issues, contact your health care provider promptly to schedule an appointment.
It is likely that you will need reoperation sometime in your life after your initial breast surgery either to correct a problem or replace or remove your breast implant. Problems such as rupture, capsular contracture, asymmetry, hypertrophic scarring (irregular, raised scar), infection and shifting can require additional surgery.
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, 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 Implants1
18% through 10 years for Saline Breast Implants2
4% through 10 years for CPGTM Breast Implants3
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.4
*Data from the primary augmentation cohort of our 10-year studies.
You and your doctor may decide to remove an implant because of a complication or to improve the cosmetic result. It’s important for you to know that breast implants aren’t expected to last a lifetime, and the longer you have your breast implants, the more likely it will be for you to have them removed, with or without replacement, for any reason.
Breast implants are considered to have ruptured when the implant shell develops a tear or hole. 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 any time after your implant surgery, but the longer the implants are in place, the higher the possibility that the implants will rupture, or the gel or saline will leak.
In our 10-year study, the overall occurrence of rupture* among augmentation patients was:
- 9.8% for MemoryGel® Breast Implants5
- 3.2% for CPGTM Breast Implants3
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 rate accordingly. 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.
*Data from primary augmentation cohort (1stand 2nd MRI Cohort pooled).
1. Summary of the Safety and Effectiveness of Mentor’s MemoryGel® Silicone Gel-Filled Implants in Patients who are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, or Revision. 10-Year Core Gel Final Clinical Study Report. April 2013
2. PIDS, SALINE-FILLED & SPECTRUM™ BREAST IMPLANTS. 02926-001 Rev D Effective April 2016.
3. Summary of the Safety and Effectiveness of Mentor’s MemoryShape™ Mammary Prosthesis in Subjects Who are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, or Revision MemoryShape™ Post-Approval Cohort Study (formerly Contour Profile Gel Core Study) Annual Report June 2014.
4. Roger N. Wixtrom, PhD, DABT; Vikram Garadi, MS, PE; John Leopold, MS; and John W. Canady, MD. Device-Specific Findings of Imprinted-Texture Breast Implants: Characteristics, Risks, and Benefits. Aesthetic Surgery Journal, 2019
5. Memory Gel Breast implants: Final Safety and Efficacy Results after 10 years follow up. p.14. Cumulative Incidence rate of confirmed rupture in the primary augmentation cohort of MRI Cohorts A and B
Important Safety Information:
The MENTOR® Collection of Breast Implants are indicated for breast reconstruction and breast augmentation - in women who are at least 18 years old for MENTOR® MemoryGel® Breast Implants, MENTOR® CPGTM Breast Implants, or MENTOR® Saline Breast Implants.
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
- Who are currently pregnant or nursing
Safety and effectiveness have not been established in patients with autoimmune diseases (for example lupus and scleroderma), a weakened immune system, conditions that interfere with wound healing and blood clotting, or reduced blood supply to breast tissue. Patients with a diagnosis of depression, or other mental health disorders, should wait until resolution or stabilization of these conditions prior to undergoing breast implantation surgery.
There are risks associated with breast implant surgery. You should be aware that breast implants are not lifetime devices and breast implantation may not be a one-time surgery. The chance of developing complications increases over time. You may need additional unplanned surgeries on your breasts because of complications or unacceptable cosmetic outcomes. Many of the changes to your breast following implantation are irreversible (cannot be undone) and breast implants may affect your ability to breastfeed, either by reducing or eliminating milk production.
Breast implants are not lifetime devices and breast implantation may not be a one-time surgery. The most common complications for breast augmentation with MemoryGel® Implants include any reoperation, capsular contracture, nipple sensation changes, and implant removal with or without replacement. The most common complications with CPGTM Breast Implants for breast augmentation include reoperation for any reason, implant removal with or without replacement, and ptosis. A lower risk of complication is rupture. The health consequences of a ruptured silicone gel breast implant have not been fully established. MRI screenings are 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 based on the data currently available on the incidence of worldwide cases.
Detailed information regarding the risks and benefits associated with MENTOR® Breast Implants is provided in several educational brochures, including the ‘Important Information for Woman Considering Breast Implants’ brochure, and the ‘Making an Informed Decision’ brochure. These brochures are available from your surgeon or visit https://breastimplantsbymentor.net/safety/mentor-safety. It is important that you read and understand these brochures when considering MENTOR® Breast Implants.
MENTOR® CONTOUR PROFILETM Breast Tissue Expanders are used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision, and tissue defect procedures. These expanders are intended for temporary subcutaneous or submuscular implantation; they should be used within a time frame determined by the physician to achieve the clinically desired degree of tissue expansion.
DO NOT use the MENTOR® CONTOUR PROFILETM Tissue Expander in patients that have a previously implanted device such as pacemakers, drug infusion devices, artificial sensing devices, etc. that could be affected by a magnetic field. Mentor has not tested the effects of radiation therapy with the MENTOR® CONTOUR PROFILETM Expander devices. The incidence of extrusion of the expander has been shown to increase when the expander has been placed in injured areas: scarred, heavily irradiated or burned tissue, crushed bone areas, where severe surgical reduction of the area has previously been performed; and where steroids are used in the surgical pocket. Detailed information about indications, contraindications, warnings, and precautions associated with the use of MENTOR® CONTOUR PROFILETM Expanders are provided in the Instructions for Use (IFU) available online at www.mentorwwllc.eu
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