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Your email address will not be published.

PSC Media Wire

More in PSC Media Wire

Why Do Some Celebrities End Up Looking Too Plastic?

Ashley Gordon, MDApril 13, 2022

How Much Did Americans Spend on Plastic Surgery in 2021?

John HammarleyJanuary 28, 2022

Are Breast Implants for Life?

Dawn TongishSeptember 17, 2021
Is TikTok Sending the Wrong Message with Beauty Algorithms?

Is TikTok Sending the Wrong Message with Beauty Algorithms?

John HammarleySeptember 8, 2021
Lockdown Face - Looking to Rejuvenate the Face in the Zoom Era

Lockdown Face – Looking to Rejuvenate the Face in the Zoom Era

Dawn TongishAugust 11, 2021
How Effective is Botox at Treating Depression?

How Effective is Botox at Treating Depression?

John HammarleyAugust 5, 2021
Artificial Intelligence and the Future of Plastic Surgery

Artificial Intelligence and the Future of Plastic Surgery

Patricia McGuire, MDJuly 21, 2021
Can you say Goodbye to Aging for Good with Prejuvenation?

Can We Say Goodbye to Aging for Good with Prejuvenation?

Dawn TongishJuly 15, 2021

Patient Consent Checklist Legislation for Breast Implant Surgery

John HammarleyMay 12, 2021