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: IDEAL IMPLANT Saline-filled Breast Implant
PMA Applicant: Ideal Implant Incorporated
Address: 5005 LBJ Freeway, Suite 900; Dallas, Texas 75244
Approval Date: November 14, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf12/P120011a.pdf
What is it? The IDEAL IMPLANT Saline-filled Breast Implant consists of multiple silicone shells within an outer shell. It has two valves that fill the device with saline. The IDEAL IMPLANT Saline-filled Breast Implant is available in a variety of sizes.
How does it work? The IDEAL IMPLANT Saline-filled Breast Implant makes the breast larger (breast augmentation) or corrects or improves the results of a primary breast augmentation (revision breast augmentation).
When is it used? The IDEAL IMPLANT Saline-filled implants are used in women who are at least 18 years old undergoing:
- Primary breast augmentation to increase breast size.
- Revision breast augmentation to correct or improve the result of a primary breast augmentation 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 favorable outcomes in the Quality of Life scales.
Common adverse effects identified in the clinical study include:
- Breast reoperation
- Implant removal with or without replacement
- Tightening of the area around the implant (capsular contracture)
- Spontaneous deflation
- Watery portion of the blood collects around the surgical incision or around the breast implant (seroma)
- Dissatisfaction with cosmetic result
- Mass of usually clotted blood that appears on the skin (hematoma)/bleeding
- Wound healing delay/tissue death (necrosis)/opening of wound (dehiscence)
- Wound infection
- Exposed implant or implant pushed out through surgical wound or skin (extrusion)
- Skin scar - unsatisfactory
- Reshaping a sagging breast (mastopexy) - unsatisfactory
- Implant not in proper position (malposition) - unsatisfactory
- Persistent breast pain
- Inadequate milk supply
- Dissatisfaction with implant size selected
- Sagging breast (ptosis) - after implant procedure
- Area of abnormal breast tissue (breast lesion)
Refer to the labeling for the clinical study.
When should it not be used? Breast implant surgery should not be performed in:
- Women with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions.
- Women with active infection anywhere in the body.
- Women who are currently pregnant or nursing.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.