PSC Media Wire

Sientra Breast Implants are Back!

Sientra Breast Implants are Back!

Sientra breast implants is back on the market and available to consumers. Once again, making the implant marketplace a triopoly alongside Mentor and Allergan.

by Carolynn Grimes
The Plastic Surgery Channel

In September of 2015, the European equivalent of the FDA placed a temporary hold on the Silimed CE mark and ultimately on the sale of Silimed breast implants in Europe. Sientra, a U.S. based breast implant company who manufactures their implants in a Brazilian manufacturing plant, was not implicated. However, the company made the voluntary decision to stop selling in the U.S. until the European and Brazilian investigations were completed.

Sientra - Mediawire.00_01_20_07.Still007

Breast Implant Investigation

Dr. Bruce Van Natta, a plastic surgeon in Indianapolis, Indiana had a special interest in this investigation, like many plastic surgeons across the U.S., he used Sientra implants regularly in his breast surgeries.

“Sientra out of an abundance of caution decided, because this red flag had been raised that they would take the high road, and remove their implants temporarily from the market until an investigation could be done,” says Van Natta.  The “matter” on the outer shell of the implants was found to be microscopic, sterile particles.  “The reality is,” says Van Natta, “you can see particulate matter floating in the air even in the operating room when the light hits just the right way.”

The “matter” on the outer shell of the implants was found to be microscopic, sterile particles.  “The reality is,” says Van Natta, “you can see particulate matter floating in the air in the operating room from cotton gauze and surgical sponges, when the light hits just the right way.”

The investigation was done by an independent third party and after extensive testing and analyses the implants were deemed safe.  “Interestingly, the company also had an independent investigator look at the other two manufacturers and low and behold, they too had particulate matter. This was really a non-issue,” states Van Natta.

Sientra - Mediawire.00_01_31_29.Still008

Sientra Implants: Safe and Back on the Market

This non-issue has caused significant repercussions not only for Sientra, but for patients, says Dr. Brad Calobrace, a plastic surgeon in Louisville Kentucky.  “I think everybody knew there was some level of particulate matter on implants, that’s just part of all implants.  There was nothing new; there was no unique concerns, and that’s very unfortunate because it always brings implants back into question,” says Calobrace.

The good news, says Calobrace, is these implants are back, they’re safe, and more competition means more choices for women.  “I hold Sientra in high regard for their willingness, just because they had a question that they really knew was ok, to pull the implants off the market, for patient safety.”

Click to add a comment
PSC Media Wire

More in PSC Media Wire

Mood Lifter: Botox for Depression and Anxiety

Mood Lifter: Botox for Depression and Anxiety

Dawn TongishFebruary 12, 2020
Plastic Surgery Trends for 2020

Plastic Surgery Trends for 2020

Dawn TongishFebruary 5, 2020
Male Call: CoolSculpting is Hot For Men

Male Call: CoolSculpting is Hot For Men

Dawn TongishOctober 23, 2019
Plastic Surgery in the Era of Snapchat, Instagram, and the Rest

Plastic Surgery in the Era of Snapchat, Instagram, and the Rest

Dawn TongishOctober 17, 2019
Plastic Surgery Apps For Kids Face Scrutiny

Plastic Surgery Apps For Kids Face Scrutiny

Dawn TongishOctober 9, 2019
Women are curious about labiaplasty.

Why Women Are Excited About Labiaplasty

Dawn TongishSeptember 18, 2019
The Right Season For Plastic Surgery

The Right Season For Plastic Surgery

Dawn TongishAugust 28, 2019
Skincare for Men: Simple Steps Without the Hassle

Skincare for Men: Simple Steps Without the Hassle

Dawn TongishAugust 7, 2019
Should Trends Be Allowed To Influence Plastic Surgery?

Should Trends Be Allowed To Influence Plastic Surgery?

Dawn TongishMay 8, 2019