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® (OPUS®) 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

Breast Augmentation Before and After Photos (Augmentation Mammoplasty with Breast Implants)

Results shown are specific to each patient and individual results will vary

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.

Breast Augmentation Presentation

Currently Available Breast Implants

Natrelle® (Allergan) Breast Implants

Dr. Mele is a Natrelle Preferred Doctor

Natrelle® (Allergan) – Allergan offers a full range of hundreds of 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 came in both smooth and textured using a highly aggressive patented texturing process named BioCell® until July 24, 2019. The textured implants were voluntarily withdrawn after an increased association was found between the highly aggressive textured surface and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). As a result, all Allergan’s shaped implants were also removed from the market because they had the BioCell® surface texturing.

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).

*The first letter in the INSPIRA® breast implant’s catalogue number identifies the type of surface the shell has:

The central letter in the INSPIRA® breast implant’s catalogue number identifies the gel cohesiveness. From soft to hard they are:

The last letter(s) in the INSPIRA® breast implant’s catalogue number identifies the profile, From low to high they are:

The Natrelle® (Allergan) Breast Implant Catalogue
(This catalogue includes no longer available BioCell® textured implants)

Sientra® (OPUS®) Breast Implants

Sientra® (OPUS®) – Sientra® is the latest company to offer FDA approved Breast Implants, and with the latest entry comes the latest technology. A tougher shell with a more cohesive, high strength silicone filling (Gummy Bear). Sientra® only offers Silicone-filled Breast Implants. The Sientra® silicone comes in two cohesivities: high strength cohesive (HSV) and a slighter firmer HSV+. HSV is available for all round implants, while HSV+ is used in the shaped implants and is also available in the moderate plus and high profile round breast implants.

Sientra® breast implant volumes range from 160 to 700 cc, and base diameters range from 9.3 cm to 17.9 cm. Implant surfaces come in both smooth and textured. Sientra’s patented texturing process, TRUE Texture is slightly more aggressive than Mentor’s® less aggressive, stamped on Siltex® texturing.

Sientra® was the first US company to have FDA approved teardrop shaped silicone gel Breast Implants. All shaped implants are textured in an effort to prevent rotation of the breast implants. There is an association between texturing and the development of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). The tumor is rare; however, the risk of developing BIA-ALCL increases with the aggressiveness of the texturing. Research is ongoing in this area.

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 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.

In 2018, Sientra® received FDA approval for their new OPUS® line of silicone breast implants and moved their manufacturing from Brazil (Silimed) to Franklin, Wisconsin, USA, (Lubrizol LifeSciences). Here is what is available from Sientra® in 2019:

The Sientra® (OPUS® Luxe) Breast Implant Catalogue

The Sientra® (OPUS® Curve) Breast Implant Catalogue

Sientra, the only Breast Implants available exclusively to Board Certified Plastic Surgeons.

Mentor® (Johnson & Johnson) Breast Implants

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®.

The Mentor® (J&J) Breast Implant Catalogue

More Breast Implant Information

For more information about the available options for Breast Implants, visit our Breast Implants Page. For more about the history of Breast Implants, check out the History of Breast Implants Page.

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