(RxWiki News) Women who want to enhance the size of or rebuild their bustlines now have a new choice. The US Food and Drug Administration has approved a new silicone breast implant.
The newly approved Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant can be used both for cosmetic purposes and to reconstruct breasts women have lost to mastectomies, trauma, breast disease or under-development.
According to the FDA, this medical device is not without its risks.
"Find out about all your choices for cosmetic or reconstructive surgery."
Silicone gel-filled breast implants are medical devices implanted under the breast tissue or under the chest muscle for breast augmentation or reconstruction. These implants have a silicone outer shell that is filled with silicone gel. The implants are available in different sizes and styles and have smooth or textured shells.
“It’s important to remember that breast implants are not lifetime devices. Women should fully understand the risks associated with breast implants before considering augmentation or reconstruction surgery, and they should recognize that long-term monitoring is essential,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health.
The FDA approval is based on seven years of study data involving 941 women. Complications were similar to those found in other breast implant studies and can include tightening around the implant, uneven appearance, infection, implant removal and need to repeat the operation.
Researchers also noticed a problem unique to the Natrelle 410 - cracks in the gel itself. This is called a gel fracture.
“The data we reviewed showed a reasonable assurance of safety and effectiveness,” Dr. Shuren said in the press release announcing the approval. “We will be looking at the results from post-approval studies that will focus on their long-term safety and effectiveness.”
Natrelle 410 is manufactured differently from other implants in that the chains of gel are bonded differently in a process known as cross-linking. The clinical significance of this manufacturing difference is not clearly understood.
Allergan, the maker of Natrelle 410, did not compare the safety and effectiveness of its implant with the three other silicone gel-filled breast implants on the market.
The FDA is requiring Allergan to perform post-approval studies to look at the long-term safety and effectiveness outcomes and risks for rare diseases. These studies will include
- Five-year follow-up of 3,500 women who received Natrelle 410 implants during the trials.
- 10-year study of more than 2,000 women who receive the new implants following FDA approval. This study will look for and report all complications and the potential for less common outcomes which can include rheumatoid arthritis, breast and lung cancer and reproductive complications.
- Five case studies to look for any association of Natrelle 410 implants and other gel-filled implants with five rare diseases: rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer and lymphoma.
- Assessment and evaluation of women’s perception of package labeling.
- Analysis of all Natrelle 410 implants removed from patients and returned to the manufacturer.
With this approval, there are currently four FDA-approved silicone breast implants on the market:
- Allergan Natrelle
- Allergan Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
- Mentor MemoryGel
- Sientra’s Silicone Gel Breast Implants