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