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Important Safety Information

Important Safety Information

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.

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. 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.

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 for breast augmentation with MemoryShape Implants include any reoperation, ptosis, and implant removal with or without replacement. A lower risk of complication is implant rupture, which is most often silent (meaning neither you nor your doctor will know you have a rupture) and can only be detected by appropriate imaging techniques such as MRI. MRI screenings are recommended three years after initial implant surgery and then every two years after to detect silent rupture. The health consequences of a ruptured silicone gel breast implant have not been fully established.

The most common complications for breast augmentation with MENTOR® Saline-filled Breast Implants include reoperation, implant removal, capsular contracture, breast pain, and implant deflation.

Detailed information regarding the risks and benefits associated with MENTOR® Breast Implants is provided in several educational brochures.

For MemoryShape Implants:

For MemoryGel® Implants:

For MENTOR® Saline-Filled Implants:

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.