Two weeks ago, Silimed, the largest manufacturer of silicone gel breast implants in Brazil was told by the Brazilian regulatory agency ANVISA to stop production of all their products.  Their products were found to be contaminated with particle of cotton and carbon.  In America, Sientra distributes Silimed, cohesive breast implants .

(The two other implant companies, Allergan and Mentor manufacture their own implants and their implants are not in question.)

The Sientra products where approved by the FDA in 2013.  They are made of cohesive gel which is claimed to hold their shape over time.

Since the discovery of the contamination, the United Kingdom, Germany and Australia put a halt on the surgical of implantation of Sientra’s breast implants until further notice.

The FDA has yet to weigh in on this problem, but it has not inspected Silimed’s facility since 2003.

http://www.raps.org/Regulatory-Focus/News/2015/09/25/23272/Fallout-Continues-from-MHRA-Suspension-of-Brazilian-Manufacturers-Implants/

For american women that have Sientra implants, certain things are unknown.   The first is, how long has this contamination been going on?    Second, is there any harm associate with the contaminants?

The Brazilian plant is regularly inspected by regulatory agencies from all over the world. No significant contamination has been found before by any of these agencies.

Also, there appears to be no evidence of any harm associated with the contaminants, but  it may take more time for problems to be recognized. The contaminants, so far, have been just cotton and carbon, but other studies are pending to confirm this.    Both contaminants, by themselves, are pretty benign.  Cotton is still used by some physicians to close wounds but it can cause a foreign body reaction like that of a small splinter .  Carbon is a common inert chemical which the body commonly ignores.  (Some jail house tattoos are commonly india ink which is carbon particles.)

I suspect little, if any problems will arise due to these contaminants.  However, if you have Sientra Cohesive Gel Implants, talk with your implanting surgeon for further information.    Sentra has notified them of the issue.  Again Allergan and Mentor implant are not part of this problem.

Question about a procedure? Interested in a consultation? CLICK HERE to email me or calling the office at 318-219-8555 and talking to my wonderful staff.

1 Comment

  1. Daughter had Sientra implants done in 2014 and is having a bad reaction to them, breast area has swollen and is being drained of ugly liquids. Dr. who did surgery wants to remove scar tissue and leave implants in and charge her $4,400 for the procedure. Should the doctor be charging to do this procedure?

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