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)
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 The textured implants were voluntarily withdrawn after an increased association was found between the highly aggressive textured surface and breast implant-associated anaplastic large cell lymphoma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).
- Natrelle® (Allergan) Saline Breast Implants are available in:
- Low profile (lowest projection) smooth round (style 68LP) 125-700 cc
- Moderate profile (mid-range projection) smooth round (style 68MP) 120-850 cc
- High profile (highest projection) smooth round (style 68HP) 160-850 cc
- Natrelle® (Allergan) Silicone Breast Implants are available in:
- Moderate profile (lowest projection) smooth round (style 10) 120-800 cc
- Moderate profile (mid-range projection) smooth round (style 40) 80-560 cc
- Midrange profile (mid-range projection) smooth round (style 15) 158-752 cc
- High profile (mid-range projection) smooth round (style 20) 120-800 cc
- Full profile (highest projection) smooth round (style 45) 120-800 cc
- Natrelle INSPIRA® (Allergan) Silicone Breast Implants are available in:
- Low smooth round (SRL, SSL and SCL) 110-610 cc
- Low Plus smooth round (SRLP, SSLP and SCLP) 125-640 cc
- Moderate smooth round (SRM , SSM and SCM) 140-755 cc
- Full smooth round (SRF, SSF and SCF) 175-770 cc
- Extra Full smooth round (SRX, SSX and SCX) 200-800 cc
*The first letter in the INSPIRA® breast implant’s catalogue number identifies the type of surface the shell has:
- S is for Smooth breast implants.
- T is for Textured breast implants (no longer available).
The central letter in the INSPIRA® breast implant’s catalogue number identifies the gel cohesiveness. From soft to hard they are:
- R is TruForm™ 1 also known as “Responsive Gel” or Cohesive Gel.
- S is TruForm™ 2 also known as “Soft Touch™” is more cohesive (stiffer) than R.
- C is TruForm™ 3 also known as Highly Cohesive Gel is stiffer than S.
The last letter(s) in the INSPIRA® breast implant’s catalogue number identifies the profile, From low to high they are:
- L is low profile.
- LP is low-plus profile.
- M is moderate profile.
- Fis full profile.
- Xis extra-full profile.
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:
- Sientra® (OPUS® Luxe™) High Strength Smooth Round Silicone Breast Implants (Gummy Bear) sizes:
- HSC Low projection (lowest) smooth round 160-700 cc
- HSC Moderate projection (mid-range) smooth round 190-700 cc
- HSC & HSC+ Moderate Plus projection (mid-range) smooth round 175-695 cc
- HSC & HSC+ High projection (high) smooth round 190-700 cc
- HSC & HSC+ Xtra High projection (highest) smooth round 275-510 cc
- Sientra® (OPUS® Luxe™) High Strength Textured Round Silicone Breast Implants (Gummy Bear) sizes:
- HSC Low projection (lowest) smooth round 160-700 cc
- HSC Low projection (lowest) TRUE Texture™ textured round 160-700 cc
- HSC & HSC+ Moderate Plus projection (mid-range) TRUE Texture™ textured round 175-695 cc
- HSC & HSC+ High projection (highest) TRUE Texture™ textured round 190-565 cc
- Sientra® (OPUS® Curve™) High Strength Shaped Silicone Breast Implants (Gummy Bear) sizes:
- HSC+ Classic base (taller than wide) TRUE Texture™ textured moderate projection 180-450 cc
- HSC+ Round base teardrop shaped TRUE Texture™ textured high projection 200-425 cc
- HSC+ Oval base (wider than tall) TRUE Texture™ textured low projection 170-500 cc
- HSC+ Oval base (wider than tall) TRUE Texture™ textured moderate projection 180-700 cc
- HSC+ Oval base (wider than tall) TRUE Texture™ textured high projection 180-550 cc
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®.
- Mentor® (J&J) Saline Breast Implants are available in:
- Moderate profile (lowest projection) smooth round 125-775 cc
- Moderate profile (lowest projection) Siltex® textured 125-525 cc
- Moderate Plus profile (mid-range projection) smooth round 175-960 cc
- High profile (highest projection) smooth round 170-750 cc
- Teardrop shaped (lowest projection) Siltex® textured saline implants 175-575 cc
- Teardrop shaped (highest projection) Siltex® textured saline implants 275-725 cc
- Mentor® MemoryGel®(J&J) Silicone Breast Implants are available in:
- Moderate Classic profile (lowest projection) smooth 130-800 cc
- Moderate Classic profile (lowest projection) Siltex® textured 130-800 cc
- Moderate Plus profile (mid-range projection) smooth 100-800 cc
- Moderate Plus profile (mid-range projection) Siltex® textured 100-800 cc
- High profile (mid-range projection)smooth 125-800 cc
- High profile (mid-range projection) Siltex® textured 125-800 cc
- Ultra High profile (highest projection) smooth 135-590 cc
- Ultra High profile (highest projection) Siltex® textured 135-535 cc
- Teardrop shaped textured highly cohesive silicone implants (CPG) (Gummy Bear) 120-775 cc in 6 styles with various widths, heights and profiles
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.