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Sientra: Dear Valued Plastic Surgeon,

The following excerpt is from the company's SEC filing.

As I have committed previously, I am sending you this update to keep you informed and provide additional details as they are available to us.

As you already know by now, there was a fire at one of the two buildings at Silimeds facility in Brazil. Based on our preliminary discussions with Silimed, we learned that the fire occurred in the building where Sientras breast implants are primarily manufactured. Silimed has indicated that a smaller production facility in Silimeds second building, which was not impacted by the fire, has the potential to be modified for breast implant manufacturing. In order to beg in the manufacturing of breast implants in this second building, certain areas in this facility would need to be reconfigured and receive certification and approval by appropriate regulatory bodies. We are currently working with Silimed to assess the feasibility and timing of such a plan.

In regards to our own review that I previously communicated, we are continuing it in earnest with the assistance of independent experts in quality management systems, Good Manufacturing Practices (GMP) and data-based risk assessment. Our review covers among other items:

Documentation related to the matter in question;

Procedures for manufacturing Sientras products;

Environmental monitoring;

Data, testing and analysis conducted by or on behalf of Silimed; and

Potential corrective actions...


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