DISCLAIMER: This blog is the author's opinon only. The views expressed herein do not necessarily reflect the views of Editorial Staff.
It's been a bad couple of months for Sientra, the North American distributor of Silimed breast implants. And it's too bad because they're a scrappy young company that gave women additional choices when it came to breast implants for cosmetic or reconstructive purposes.
Just a little background before we get to Sientra: Silimed (not Sientra) is a Brazilian company that has been making silicone breast implants since 1978. In 2006, Sientra was founded to be the exclusive distributor of Silimed implants in the US. Sientra received their initial FDA approval for their round and shaped implants in 2012 and started selling breast implants to plastic surgeons. Sientra's entry into the market broke the existing duopoly of breast implant manufacturers in the US. Prior to Sientra, all implants used in the US were sold by Mentor, a subsidiary of Johnson and Johnson, and Allergan, the makers of BOTOX® Cosmetic and Juvederm®.
Unfortunately for Sientra, just as 2012 started out with good news of the FDA approval of their implants, it was also the beginning of their troubles. Once Sientra had a product to sell, they needed a workforce and many of the new Sientra employees back in 2012 were former Mentor employees. Apparently Mentor wasn't very happy about this. Mentor sued Sientra along with many of the former Mentor, now Sientra employees, in multiple states. In court, Mentor accused Sientra of corporate raiding and other anti-competitive tactics. Sientra prevailed when the jury disagreed with Mentor's argument. If Mentor was displeased before the suit, there were probably exponentially more displeased after losing the suit(s).
Fast forward to 2015, September to be exact. A German inspection team, inspecting the Silimed factory in Brazil as a matter of course for Germany's version of the FDA, found impurities on the surface of the Silimed implants. Specifically, they found cotton and silica particles that are used in the processing and manufacturing of implants. While it has been known in the past that particulate matter exists on implants, these particles are sterilized along with the implant sterilization process. Per Sientra communications, "no reports of adverse events and no risks to patient health have been identified related to this matter. This finding has been reiterated by the foreign regulators reviewing this matter in their public announcements."
However, in an overabundance of caution while the manufacturing process was further evaluated, European and UK regulatory agencies revoked Silimed's certification for their implants in Europe. Because Sientra's implants are made by Silimed in a similar factory in Brazil, Sientra took the voluntary step of halting sales of their implants in the US. The FDA did not require Sientra to halt sales but they did agree with this cautious course of action.
On the surface, no pun intended, it appears that the presence of particulate matter on implants was discovered incidentally by the German inspection team. However, based purely on hearsay amongst plastic surgeons such as myself, it may be Mentor who is behind this latest Sientra crisis. Through several sources, that don't include anyone associated with Sientra, the theory goes like this: Mentor obtained a Silimed/Sientra implant, presented it to the FDA's European counterpart to start this chain reaction of disqualification of Silimed implants in Europe which led to pressure on Sientra to voluntarily suspend sales in the US. Since no one "in the know" is talking, this is difficult to confirm. As of this time, Silimed's certification revocation in Europe remains in place and Sientra's voluntary halt in US sales continues.
But Sientra's troubles continue. At the end of October, the Silimed plant in Brazil that manufactures Sientra's implants was destroyed in a fire. The cause of the fire is not known, but Mentor is not suspected!
Finally, in a possible effort to remove the proverbial lightning rod that is the root cause of Mentor's ire, the founder and CEO of Sientra has stepped down as of November 12th, 2015. He is being replaced by an existing Sientra board member.
Whether Mentor is truly behind Sientra's troubles may only be determined through a more extensive investigation. If they are found to be responsible for bringing the European and US agencies into "particulate-gate," their plan may backfire. The presence of sterile cotton and silica on the surface of silicone implants is common to all three companies' manufacturing processes. That means that whatever change in regulations are required after the European and FDA's review is complete will ultimately affect Mentor and Allergan. So in a sense, Mentor may bring more regulation on itself. Aside from the fact that the presence of these sterile particles has not been shown to cause any adverse effects, implants are routinely washed in betadine or antibiotic solution prior to implantation. Therefore, the particulates are cleansed from the surface of the implant and never make it into the patient's body.
The draw of plastic surgeons to Sientra in the past has been their commitment to only selling implants to plastic surgeons. Allergen and Mentor will sell breast implants to any doctor. Surprisingly, there is no law against an ER doctor or ObGyn performing breast augmentation even though they lack training in the field of plastic surgery. Again, it's not illegal but you could argue it's morally reprehensible to perform an operation on a patient without proper training. By committing to only plastic surgeons, Sientra created a following of loyal surgeons. This and the fact that everyone loves the underdog has also helped their mystique and early success against the better financed and larger breast implant manufacturers, Mentor and Allergan.
Time will only tell but hopefully Sientra will survive these setbacks and prove that the little guy can win and underhanded tactics will lose out to honest competition.
Dr. Jonathan Kaplan is a board-certified plastic surgeon based in San Francisco, CA and founder/CEO of BuildMyBod, an online marketplace for healthcare services.