U.S. Breast Implant Manufacturers
In the United States, Breast Implants are regulated by the FDA. Currently, there are three independent Breast Implant manufacturers. Two, Natrelle® (Allergan) and Mentor® (Johnson & Johnson), make both Saline Breast Implants and Silicone Breast Implants. Sientra® (Silimed) makes the next generation high strength Silicone Breast Implants in both shaped and round contours.
All three Breast Implant Manufacturers have passed rigorous FDA standards targeting not only the manufacturing process, but Breast Implant safety and effectiveness. Long term reporting and large follow-up studies are required of each company. Dr. Joseph Mele, is an investigator for many of the past and ongoing Breast Implant follow-up studies
The information provided here, cannot substitute for an in person Breast Augmentation consultation with a Board Certified Plastic Surgeon. Options in Breast Augmentation are constantly changing, so it is important to have an experienced Breast Augmentation Professional, like Dr. Mele, to help interpret how this information relates to your body and your goals.
New Breast Implants become available from time to time. The goal is always to improve the safety and predictability of Breast Augmentation. It is important that all breast implants be properly manufactured, and equally important that there are follow-up studies to be certain that the Breast Implants are performing as expected. All current US Breast Implant makers are subject to unannounced inspections of their facilities and records, and are required to perform large follow-up studies to prove that their Breast Implants are performing as expected.
Natrelle® (Allergan) Breast Implants
Natrelle® (Allergan) – Allergan offers a full range of over 140 different Breast Implants including both Saline-filled Breast Implants and Cohesive Silicone-filled Breast Implants all marketed under the brand name Natrelle®. Volumes range from 80 to 850 cc. Diameters range from 7.4 cm to 17.2 cm. Surfaces come in both smooth and textured using a highly aggressive patented texturing process named BioCell®. Natrelle INSPIRA® is the newest edition to the Natrelle® breast implant line and provides five different projections (low, low plus, moderate, full and extra full) and two types of cohesive silicone gel fillings (TruForm 1 and TruForm2).
Natrelle® (Allergan) Saline Breast Implants are available in:
Natrelle® (Allergan) Silicone Breast Implants are available in:
Natrelle INSPIRA® (Allergan) Silicone Breast Implants are available in:
Mentor® (J&J) – Mentor® offers a full range of Breast Implants including both Saline-filled Breast Implants and Silicone-filled MemoryGel® Breast Implants. Volumes range from 80 to 850 cc. Diameters range from 8.1 cm to 18.2 cm. Surfaces come in both smooth and textured using a less aggressive patented texturing process named Siltex®.
Mentor® (J&J) Saline Breast Implants are available in:
Mentor® MemoryGel®(J&J) Silicone Breast Implants are available in:
Sientra® (Silimed) – Sientra® is the newest company to offer FDA approved Breast Implants. With the latest entry comes the latest technology. A tougher shell with a more cohesive, high strength silicone filling (Gummy Bear). Sientra® offers Silicone-filled Breast Implants and does not offer Saline-filled Breast Implants. They are the first US company to have FDA approved teardrop shaped silicone gel Breast Implants. Volumes range from 160 to 700 cc. Diameters range from 9.3 cm to 17.9 cm. Surfaces come in both smooth and textured. Sientra's patented texturing process, TRUE Texture is about half way between Natrelle's® more aggressive BioCell®, and Mentor's® less aggressive Siltex®.
In 2014, Sientra® expanded their breast implants catalogue by adding two new projections to their Smooth Round Silicone Breast Implant product line. The breast implants sold up until the end of 2014 called Smooth Round High Projection were renamed Smooth Round Moderate High Projection, and two new and higher projection profiles were added, The Smooth Round Moderate Plus Projection breast implants have a bit more projection than the Smooth Round Moderate High Projection breast implants. And to add to the confusion, the old Smooth Round High Projection name was repurposed to the new highest profile line of smooth round breast implants. This means Sientra® Smooth Round High Projection breast implants used through 2014 have a different shape (lower profile) than Sientra® Smooth Round High Projection breast implants placed after the end of 2014. Fortunately, the serial numbers did not change, so any Board Certified Plastic Surgeon can easily tell which breast implant was used if have your Breast Implant ID card or by contacting Sientra® directly.
Sientra® (Silimed) High Strength Round Silicone Breast Implants (Gummy Bear) sizes:
Sientra® (Silimed) High Strength Shaped Silicone Breast Implants (Gummy Bear) sizes:>
Sientra, the only Breast Implants available exclusively to Board Certified Plastic Surgeons.