Sientra breast implants were very popular when they came out a few years ago. They were eventually used in seven to twelve percent of all breast augmentations in the United States and were considered a Wall Street darling (NASDAQ:SIEN). However, all of that changed earlier this year when the company saw a downturn in its success.
The Issue With Sientra Breast Implants
Ever since the beginning of September, the company was forced to stop production and none of its products have been sold in the United States since. Brazilian regulators where Sientra’s Silimed breast implants are manufactured were forced to shut down the only factory that makes the company’s sole silicone implants, Silimed Industria de Implantes Ltda.
According to Dr. Wiener, contaminants were found on the surface of the breast implants that were confirmed by an Australian research group who hypothesized the contaminants to be silicone particles and cotton lint. They also believed these contaminants were taken on during the manufacturing process.
This comes just after the Sientra breast implants were banned in Europe for the same reason. Sientra had its marketing certificate suspended in the entire continent because a European inspection agency found possibly hazardous particles on the surface of its implants. In response, the company voluntarily halted sales of their product in the United States, and the FDA has expressed concern but has not recalled the implants.
More Trouble for Sientra
Almost immediately after the announcement, the company’s stock took a huge hit, and analysts have discontinued coverage. The stock went from its peak of $25.75 in June of 2015 to $8.31 as of this week. This comes after an announcement just this month that Sientra is under investigation by the U.S. District Court for the Central District of California concerning alleged breaches of fiduciary duties by a number of executives.
According to the complaint, it is alleged that from March to September of this year Sientra violated law by making misleading statements regarding their exclusive reliance on their Brazilian plant that posed quality control risks. In addition, the complaint states the manufacturing processes was contaminated, and statements made by Sientra on quality control, as well as other financial statements, were false.
Which Breast Implants Are Safe?
With decades of experience in cosmetic surgery, we have the knowledge and dedication to select only the best and safest products for all of our procedures. We use Natrelle breast implants due to their flexibility and durability. The implants are filled with INSPIRA™, which is the same FDA-approved silicone gel they have used for over ten years. It comes in 200 different variations, which means they have several models available for every woman, no matter what her size or goals.
A recent study conducted this year found that women undergoing a breast augmentation after a mastectomy using Natrelle 410 silicone gel extra-full projection implants had a low risk of complications after surgery two years later. After the same period of time, the patient satisfaction rate was 91.1% while the physician satisfaction rate was a little higher at 96.3%.
More About Breast Implants
To learn more about which types of breast implants we use in our breast augmentation procedures, click here.
Sources (for reference):
http://www.healio.com/aesthetics/breast-surgery/news/online/%7B180cda74-5d7c-4a03-8b02-153df6109f8f%7D/five-recent-developments-in-breast-surgery
http://www.realself.com/question/chicago-il-sientra-implants-safe
http://www.tickerreport.com/banking-finance/1076962/sientra-inc-sien-shares-down-12/
http://www.bloomberg.com/news/articles/2015-10-16/sientra-breast-implants-stuck-in-limbo-after-supplier-s-setbacks