This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: MemoryShape Breast Implants
PMA Applicant: Mentor Worldwide LLC
Address: 201 Mentor Drive; Santa Barbara, California 93111
Approval Date: June 14, 2013
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060028a.pdf
What is it? The MemoryShape Breast Implant is a silicone shell filled with clear silicone gel. The silicone gel is firmer (more cohesive) than Mentor’s previously approved implant (P030053). The MemoryShape Breast Implant is available in a variety of sizes.
How does it work? The MemoryShape Breast Implant is intended to make the breast larger (breast augmentation) or to restore or replace breast tissue (breast reconstruction). It is surgically implanted beneath the breast tissue, either on top of the chest muscle or underneath part or all of the chest muscle.
When is it used? The Mentor MemoryShape Breast Implants are indicated for females for the following uses (procedures):
- Breast augmentation for women at least 22 years old. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.
- Breast Reconstruction. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the results of a primary breast reconstruction surgery.
What will it accomplish? The implant increases the size of the breast. A majority of subjects in the clinical study reported favorable satisfaction and Quality of Life.
Common adverse effects identified in the clinical study include:
- Uneven appearance (asymmetry)
- Breast pain
- Breast sensation changes
- Tightening of the area around the implant (capsular contracture)
- Excess skin/tissue
- Gel fracture
- Enlarged scar remaining after wound heals (hypertrophic scarring)
- Implant immobility (a decrease in the natural movement of the breast, particularly at the sides and/or bottom)
- Implant removal with or without replacement
- Implant rotation
- Implant rupture
- Lack of projection (how far the breast extends outward from the chest wall)
- Loss of definition of inframammary fold (the crease under the breast where the breast and chest meet)
- Metastatic disease (A stage of cancer after it has spread from its original site to other parts of the body)
- Nipple sensation changes
- Implant felt through skin (palpability)
- Numbness/tingling (paresthesia)
- Patient dissatisfied with aesthetic appearance of the breast
- Patient dissatisfied with feel of the implant
- Position dissatisfaction
- Sagging or drooping of breast (ptosis)
- Recurrent breast cancer
- Additional surgeries, including those to change style or size (reoperation)
- Watery portion of the blood collects around the surgical incision or around the breast implant (seroma)
- Size change - patient request
- Size change - physician assessment only
- Skin lesion
- Opening of a wound (wound dehiscence)
Refer to the labeling for the clinical study.
When should it not be used? Breast implant surgery should not be performed in women:
- With active infection anywhere in the 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.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available.