PSC Media Wire

Sientra Implants Make Long Anticipated Return to the U.S. Market

Sientra Implants Make Long Anticipated Return to the U.S. Market

Sientra breast implants are back in the United States. This fall when Silimed had their CE mark temporarily suspended by the main European device regulator, Sientra, who  shared a manufacturing facility with Silimed,  voluntarily withdrew their products from the U.S. market to allow an investigation of Silimed’s manufacturing facility to take place.

By John Hammarley
The Plastic Surgery Channel

After a period of months where implants were off limits to surgeons – and Sientra’s stock and future confidences took a tremendous tumble – the company has given the green light to U.S. surgeons to use the implants.

CEO, Jeffrey Nugent in a letter noted, “We have completed extensive independent studies… and the overwhelming conclusion is that we are more confident that all Sientra products meet the standards of quality and safety.” He elaborates further that their controlled reentry into the U.S. will allow surgeon customers to readily access Sientra’s “significant inventory” of approved implants.

What this hiccup means for the company, only time will tell.  The FDA has to date voiced no concerns over Sientra devices, and for now, U.S. surgeons and patients have more breast implant options and choices!

Click to add a comment

Leave a Reply

Your email address will not be published. Required fields are marked *

PSC Media Wire

More in PSC Media Wire

Asymmetry.

If Things Seem Asymmetrical, Can Surgery Level Them Out?

John HammarleyMarch 27, 2017
Surgically changing your ethnic looks.

Changing Your Ethnic Looks Can be Done, But Should It?

John HammarleyMarch 14, 2017
Plastic surgery streamed live.

Live Streamed Surgery, Is It a Good Idea?

Dawn TongishMarch 7, 2017

First a Date, Now a Doctor – Find Your Match Online

Dawn TongishMarch 1, 2017
Natural - not extreme - surgery.

Natural – Not Extreme – Plastic Surgery Is The Norm

Dawn TongishFebruary 20, 2017

Plastic Surgery: Is There Right or Wrong Reasons?

Dawn TongishFebruary 13, 2017
Are there too many breast implant choices?

Are There Too Many Implant Choices?

Camille Cash, MDFebruary 7, 2017

Obese Patients and Plastic Surgery

John HammarleyJanuary 27, 2017
Fabulous 50 - Maintaining Youth When 50 Approaches

Look Younger and Feel Fabulous After 50

Dawn TongishJanuary 17, 2017