ESTEEM CANBERRA

Suite 14, Manuka Court

11 Bougainville Street

Manuka ACT 2603

ESTEEM BRISBANE

Suite 65, Level 2

121, Wickham Terrace

Ballow Chambers

Spring Hill QLD 4000

ESTEEM SYDNEY

Rpah Medical Centre

G10/100 Carrillon Ave

Newtown 2042

NEW

Breast Implants

of Allergan

Approved by

FDA

The United States Food and Drug Administration have

approved the Natrelle 410 Highly Cohesive Anatomically

Shaped Silicone Gel Filled Breast Implants. This was for

the purpose of increasing breast size in women who are

at least 22 years of age, and also to rebuild breast tissue

in women at any age.

The breast implants are made out of silicone outer shell

that is filled with silicone gel. They come in different sizes

in either smooth or textured shells.

The approval was based by the FDA on the seven years’

worth of data from 941 women. Most of the complications

and outcomes also reflect those that are found in previous

breast implant studies. This includes capsular

contracture (the tightening of the area around the breast

implants), asymmetry, infection, re-operation and implant

removal.

In addition to the problems mentioned above,

investigators also observed fissures or cracks on the gel

in Natrelle implants. This is called gel fracture and is

typical to this type of implant.

Natrelle 410 implants contains silicone gel that contains

more cross-linking compared to the silicone gel used in

previously approved Natrelle implants from Allergan.

Cross linking refers to the bonds that link one silicone

chain to another. The increased amount of cross linking

results to a firmer implant.

Jeffrey Shuren, M.D., who is the director of the FDA’s

Center for Devices and Radiological Health said that

“the data reviewed showed a reasonable assurance of

safety and effectiveness”. But he also adds that the

agency will also be looking at the results from post-

approval studies that will focus on the implants’ long

term safety and effectiveness.

Saline

Silicone Saline

Silicone

*images courtesy of Allergan Inc

Anatomical (Teardrop Shape)

Round Shape

Silicone VS Saline

The Natrelle™ Style 410 Matrix of Implants

The FDA requires Allergan to conduct post-approval

studies which includes a five-year follow-up of about

3,500 women who received the implants as part of the

access study by the company. Also with that they are also

required a 10-year follow-up of more than 2,000 women

in order to point out any long term complications that

could occur. Five case-control studies are also required

to assess the correlation between the implants and rare

diseases.

In addition to what is mentioned above, Allergan is also

required by the FDA to assess the women’s perceptions

of the patient labeling and implant analysis from those

that are removed from patients and are returned to the

manufacturer.

But despite that patients should still recognize the fact

that breast implants are not lifetime devices. There are

inherent risks to having implants that should be fully

considered before submitting to breast augmentation and

reconstruction surgery. Also women should always see to

it that they maintain a long-term monitoring.

As of the present, there are now four FDA-approved

silicone gel-filled breast implants that are available in

the US. These are manufactured by three companies

namely, Allergan, Sientra, and Mentor.

So for those who are planning to get breast enhancements

any time soon, see to it that you thoroughly discuss with

your surgeon the type of implants that you want. Also

make sure that you get an FDA approved product.

Natrelle™ Style 410 Form Stable Highly Cohesive

Anatomical Implants

BEFORE & AFTER PHOTOS

ESTEEM COSMETIC STUDIO

OUR PRACTICE IS BUILT ON A FIRM COMMITMENT TO

EXCELLENCE for local residents and for all who travel here in search

of perfection, personal attention, state-of-the-art technology, and

superior results.

We employ only the top medical professionals in our field, ensuring

our patients' safe care and beautiful results.

DISTINGUISHED SURGICAL

LEADERSHIP

Surgeons, Dr. Andrew Kim, Dr. Angelo Tsirbas, Dr. Masroor Alam, Dr.

Ash Sankarayya and Dr. Michael Zacharia, are fellows of the

Australasian College of Cosmetic Surgeons, the benchmark for

standards when it comes to Cosmetic Surgery.

We are located in Canberra, Brisbane and Sydney, our beautiful

office was personally designed by our surgeons and our staff

SURF US: www.esteemstudio.com.au

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