New FDA Approval of Sientra Silicone Breast Implants
In a recent Medscape Education article
, it was reported that the third brand of silicone implants has been approved by the FDA. This new brand is produced by Sientra.
The two previously approved silicone breast implants
were given approval by the FDA in November, 2006. They are the Natrelle, manufactured by Allergan and MemoryGel, manufactured by Mentor.
Third Type of Silicon Breast Implants Manufactured by Sientra
Almost 300,000 women received breast augmentation
in the United States in 2010, a number which has consistently climbed each year. It is estimated that there are 5-10 million women with breast implants worldwide.
Prior to granting approval, the FDA typically insists on rigorous clinical testing. In this case, three years of clinical trials were undertaken with a testing group of 1788 women. It was determined that the potential side effects of these new implants were no more frequent or serious than the other, currently accepted silicone or saline implants.
The final findings of the FDA report stated that: “based on the totality of the evidence, the FDA believes that silicone gel–filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled.”
The approval of the Sientra silicone implants required a number of post-approval conditions, including:
- Seven years of follow-up studies on the 1788 female participants of the previous clinical trials
- Undertaking of five studies that evaluate any links between the new implants and lymphoma, cervical/vulvar cancer, brain cancer, neurological disease and connective tissue disease
- Monitoring of almost 5000 recipients of the implants for the next ten years, to see if they develop long-term complications
The FDA report also cautioned that it is important for women who undergo breast augmentation to be aware that they may require revision of their implants with time, and that the implants should only be used in women older than 22 years of age. (The Medscape article linked to in the first paragraph may require a
Medscape account to view.)