Breast Implant Surgery Safety
Choosing to have breast augmentation and reconstruction surgery is an incredibly personal decision. It’s important that you and your surgeon consider all the facts about the benefits and risks associated with breast implants prior to making choices about your breast implant surgery.
Breast implants are US FDA-approved and safe and effective for breast reconstruction and augmentation and are chosen by hundreds of thousands of woman every year.
Are You Eligible for Breast Implant Surgery?
Before you decide to move forward with breast implant surgery you should have a detailed conversation with your doctor to review your medical history.
Contraindications
A contraindication is a condition or circumstance that, if present, means a procedure should not be done because the risk of complication outweighs the benefits. Adequate studies have not been performed to demonstrate the safety of breast implant surgery in women with the following conditions or under these circumstances:
- Women with active infection anywhere in their bodies
- Women with existing cancer or pre- cancer of their breast who have not received adequate treatment for those conditions
- Women who are pregnant or nursing
If you have any of the above conditions or circumstances, breast implant surgery should not be performed at this time. Failure to take into consideration these contraindications may increase the risks involved with surgery and could cause you harm.
Precautions
If you have any of the following conditions be sure to notify your doctor as the risks of complications may be higher if you have any of these conditions:
- An autoimmune disease, or family history of autoimmune disease
- A weakened immune system
- Planned chemotherapy following breast implant placement
- Planned radiation therapy to the breast following breast implant placement
- Conditions that interfere with wound healing and/or blood clotting
- Reduced blood supply to the breast tissue
- Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders
In addition, it’s important that you know the following precautions:
- Patients who undergo breast implant surgery with connective tissue diseases (CTD) may experience an increased risk of wound dehiscence (impaired wound healing), infection and bleeding (likely due to their ongoing medical management) that may require further treatment.
- Some patients with breast implants have reported experiences of neurological and/or rheumatological diseases. Mentor is currently collecting data to further understand these potential risks and their possible association with breast implants.
Caution for Smokers
Smoking can compromise recovery a great deal by causing the blood vessels to constrict, reducing blood flow, and the oxygen it carries, to the surgical area. Your tissues need this blood and oxygen supply to heal properly. When your blood supply is compromised, wound healing will be affected.
That’s why surgeons ask patients to refrain from smoking for one to five weeks prior to and after surgery. It’s important that you ask your surgeon what his or her specific recommendation for you would be.
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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This publication is not intended for distribution outside of the EMEA region.
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