The NATRELLE® Collection is the pinnacle of over 30 years experience in manufacturing breast implants and tissue expanders which include the latest technologically advanced generation of breast implants. With continued investment in Research & Development we have amassed more clinical data to support the safety of our products than any other breast implant manufacturer.
Nothing is more important to us than patient long-term health and safety. That’s why breast implants from The NATRELLE® Collection undergo a battery of tests to ensure their innovative design meets all relevant national and international quality control standards and Current Good Manufacturing Practice (CGMP) standards. From start to finish it can take up to 12 days to manufacture an Allergan implant which undergoes almost 100 quality control tests, including materials inspection, product inspection and testing. This is why The NATRELLE® Collection is your assurance of quality for every one of the more than three quarter million implants and tissue expanders we manufacture and supply annually from our state of the art facility.
Clinical experience with silicone gel-filled implants
Like many other medical devices on the market today, silicone gel-filled breast implants have evolved substantially over the last two decades. Today's NATRELLE® silicone gel-filled breast implants have an advanced technology thanks to several refinements in product design and manufacturing. The most significant advancements available today include a more cohesive silicone gel and a thicker, yet supple shell with an additional barrier layer that is distinct from earlier breast implant devices.
NATRELLE® silicone gel-filled breast implants have been marketed for more than 30 years in over 60 countries.
Thanks to these key advancements in design NATRELLE® silicone gel-filled breast implants feel more like natural breast tissue.
Low long-term rupture rates
Allergan has conducted extensive clinical studies in the United States. These studies show that silicone gel-filled implants have low long-term rupture rates. In fact, the results of the United States research found that after 6 years, 96.5% of implants were still intact.
Today's breast implants in The NATRELLE® Collection undergo thorough testing and meet the very high standards of Allergan quality. They are backed by a warranty that reflects the Allergan commitment to quality.
Through ongoing research Allergan is constantly assessing the impressive long-term data on our range of silicone gel-filled breast implants.
NATRELLE® silicone gel-filled breast implants are one of the most studied medical devices in existence. There have been many peer-reviewed studies and published reports involving silicone gel-filled breast implants, including robust epidemiological studies supporting their use.
For patients and surgeons alike, choosing the right implants is an important decision and quality assurance is an integral part of this.
NATRELLE® style saline and gel- filled breast implants listed below and implanted in the United States and Canada after April 1, 2002* are eligible for coverage under the Allergan ConfidencePlus® warranty programs provided that the implants were used:
- As intended by appropriately qualified and licensed surgeons in accordance with current and accepted plastic surgery techniques
- In accordance with the current NATRELLE® style implant Directions for Use.
Qualified Natrelle style breast implants
- Saline- Filled Breast Implants: Style 68HP, 68MP, 68LP, 163, 168, 363LF, 468
- Gel-Filled Breast Implants: Style 10, 15, 20, 40, 45, 110, 115, 120, 410, Inspira
The NATRELLE® warranty applies to all NATRELLE® silicone gel-filled implants and the NATRELLE® 150, provided the product has been used:
- after the 31st August, 2010
- any implants used prior to 31 August 2010 are covered by the Allergan product warranty supplied by Allergan
- as intended by appropriately qualified and licensed surgeons, in accordance with current and accepted plastic surgery techniques.
- in accordance with the current NATRELLE® breast implant directions for use.
- this guarantees replacement of an implant where there has been loss of shell integrity resulting in implant rupture that requires surgical intervention. This warranty does not cover any related surgical costs associated with implant replacement.
The NATRELLE® warranty does not apply to the following:
- Dissatisfaction with implant size or aesthetics
- Adverse reactions other than implant rupture
- Removal of implants due to capsular contracture, wrinkling or rippling
- Loss of product Integrity caused by cosmetic revision surgery
- Loss of product caused by open or closed capsulotomy
- Surgery on the opposite breast to replace an intact implant
- Gel deformation/gel fracture
- Saline products
- Other manufacturers products
- Products broken or ruptured at the time of implementation
To make a claim please contact your surgeon. We thank you for choosing from the NATRELLE® Collection.