As you may have read in this previous post, Sientra breast implants have had a trying several months. But that may soon be behind them. As of tomorrow, March 1st 2016, they’ll be available again.
The truth is, nothing was ever wrong with the implants. In an overabundance of caution, the company chose to stop selling their silicone breast implants voluntarily. At issue was evidence that sub-milimeter sterile particles like silica and cotton were found on the outside of the implants. The same particles that are also found on their competitors implants (Allergan and Mentor) during the manufacturing process.
Safety of Sientra Implants?
No reports ever came to light that these particles caused any harm to patients. In fact, most particles never made it into the breasts of patients because plastic surgeons routinely wash the implants in a sterile antibiotic or betadine solution prior to implantation. So those sterile particles were ultimately washed off the implants before placement.
This really turned out to be a non-issue from a safety standpoint but certainly not a non-issue from a financial standpoint to Sientra (SIEN) and their shareholders. But wasn’t that really the point? There are unconfirmed but certainly assumed-to-be-true reports that Sientra’s competitor Mentor alerted the FDA and German FDA as to these contaminants by sending them a Sientra implant for evaluation.
From my understanding, the FDA passed on intervening, but once the German version of the FDA got involved, the US FDA reopened the case and Sientra cooperated and stopped selling their implants temporarily (and voluntarily). During this stoppage, Sientra reviewed their processes to gain a favorable review by all agencies involved. What is unclear is did they substantively change anything?
In the interim of these machinations, the former Sientra CEO stepped down and eventually left the board. This appears to be more a political decision and a failure to recognize the fluidity of the situation rather than an admission of wrongdoing in their manufacturing processes. Regardless, Sientra lives to fight another day. Let’s hope they win the fight for the little guy!
To check pricing information on breast augmentation and Sientra implants from Dr. Kaplan, click here.