Common Complications
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.
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).
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 (BIA-ALCL). This cancer occurs more commonly in patients with textured breast implants than smooth Implants, although rates are not well defined. Some patients have died from BIA-ALCL.
- Patients receiving breast implants have reported a variety of systematic 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.
The sale and distribution of Mentor Breast Implant Devices are restricted to users and/or user facilities that provide information to patients about the risks and benefits of the device prior to its use in the form and manner specified in approved labeling to be provided by Mentor Worldwide LLC.
Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.
Caution: US law restricts this device to sale by or on the order of a physician.
The MENTOR® Collection of Breast Implants are indicated for breast augmentation - in women who are at least 22 years old for MENTOR® MemoryGel® Breast Implants or MENTOR® MemoryShape® Breast Implants, and at least 18 years old for MENTOR® Saline Breast Implants. MENTOR® Breast Implants are also indicated 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 breasts 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. 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.
Consult your physician for a full discussion of risks and benefits to determine whether this procedure is right for you. The success of this procedure depends on many factors, including your physical condition and your body’s ability to tolerate the procedure. Use care in the selection of your doctors and hospital, based on their skill and experience.
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 MemoryShape® Implants for breast augmentation include reoperation for any reason, implant removal with or without replacement, and ptosis. The most common complications for breast reconstruction with MENTOR® MemoryGel® Breast Implants include any reoperation, implant removal with or without replacement, and capsular contracture. The most common complications with MENTOR® MemoryShape® Breast Implants for breast reconstruction include reoperation for any reason, implant removal with or without replacement, and capsular contracture. The most common complications for breast reconstruction with MENTOR® Saline-filled Breast Implants include re-operation, implant removal, capsular contracture, breast pain, and implant deflation. 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 incidence of worldwide cases.
Detailed information regarding the risks and benefits associated with MENTOR® Breast Implants is provided in several educational brochures for both augmentation and reconstruction:
For Augmentation: Important Information for Augmentation Patients about MENTOR® MemoryGel® Breast Implants. Patient Educational Brochure – Breast Augmentation with MENTOR® MemoryShape® Breast Implants and Quick Facts about Breast Augmentation & Reconstruction with MENTOR® MemoryShape® Breast Implants.
For Reconstruction: Important Information for Reconstruction Patients about MENTOR® MemoryGel® Breast Implants. Patient Educational Brochure – Breast Reconstruction with MENTOR® MemoryShape® Breast Implants and Quick Facts about Breast Augmentation & Reconstruction with MENTOR® MemoryShape® Breast Implants.
Saline-Filled Breast Implants: Making an Informed Decision.
These brochures are available from your surgeon or visit www.mentorwwllc.com. It is important that you read and understand these brochures when considering MENTOR® Breast Implants.
ARTOURA® Breast Tissue Expanders and CONTOUR PROFILE® Breast Tissue Expanders are used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision, and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.
ARTOURA® Breast Tissue Expanders and CONTOUR PROFILE® Tissue Expanders contain a magnet within the internal injection domes and are NOT MRI compatible. The device could be moved by the MRI causing pain or displacement, potentially resulting in a revision surgery. DO NOT use the ARTOURA® Breast Tissue Expander and CONTOUR PROFILE® 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 ARTOURA® Breast Tissue Expanders and CONTOUR PROFILE® 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 ARTOURA® Breast Tissue Expanders and CONTOUR PROFILE® Expanders are provided in the Instructions for Use (IFU) available online at www.mentorwwllc.com
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