Silicone Gel-Filled Breast Implant Approved By FDA, With Conditions

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Main Category: Breast Cancer
Also Included In: Cosmetic Medicine / Plastic Surgery;  Medical Devices / Diagnostics
Article Date: 11 Mar 2012 - 0:00 PDT
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'Silicone Gel-Filled Breast Implant Approved By FDA, With Conditions'

Sientra Inc's silicone gel-filled breast implant for breast reconstruction or augmentation has been approved by the FDA, as long as the company carries out post-approval studies to assess the device's long-term effectiveness, safety, and rare disease outcomes. The implant is approved for females aged at least 22 years.
These implants are surgically implanted either under the chest muscle or under breast tissue - the aim is to enlarge the breasts, or rebuild them after breast cancer surgery or some breast abnormality.
This implant has an outer shell made of silicone, and is filled will silicone gel. Shells have either a smooth or textured surface, and come in various sizes.



Breast reconstruction includes: The replacement of tissue taken out because of cancer or traumaAddition of tissue for a severe breast abnormalityRevision surgery to improve or correct a previous primary breast reconstruction procedureBeast augmentation includes: Primary breast augmentation to make the breast biggerRevision surgery to correct or improve a previous breast augmentation procedureIncluding this latest approval, there are now three silicone gel-filled breast implants in America which are FDA-approved. They are made by Sientra, Mentor and Allergan.
William Maisel, M.D., M.P.H., deputy director for science in the FDA's Center for Devices and Radiological Health, said:

"Data on these and other approved silicone gel-filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness.
"It's important to remember that breast implants are not lifetime devices. Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential."

Sientra submitted its request for approval by sending the FDA three years' worth of clinical data from 1,788 patients. Outcomes and complications did not differ significantly from other breast implant studies, or previous studies using the same implant, the FDA informs. The latest study also included data on capsular contracture (tightening of the area around the implant), re-operation, removing the implant, infection, and asymmetry.
Sientra will also: Monitor the 1,788 pre-approval trial participants for a further 7 yearsCarry out a 10-year study involving 4,782 implant recipients. The study will gather data on long-term local complications, including rheumatoid arthritis, and lung and breast cancers, as well as capsule contracture.Carry out five case-control studies to determine what the link might be between this newly approved silicone gel-filled breast implant and five rare diseases: lymphoma, cervical/vulvar cancer, brain cancer, neurological disease, and connective tissue disease.Maisel said:

"The design of these post-approval studies will require Sientra to collect valuable safety information with adequate enrollment and follow-up. The FDA is committed to working with breast implant manufacturers to collect useful post-market data on long-term safety and effectiveness."

Written by Christian Nordqvist
Copyright: Medical News Today
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