FDA Approves New Silicone Gel Implant

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Most women who have mastectomy to treat breast cancer go on to have one or both breasts reconstructed. There are many ways to reconstruct a breast. Tissue from the back, belly, buttocks, or other part of the body can be used to create a new breast. Saline or silicone gel implants are probably the most common choice.

The U.S. Food and Drug Administration (FDA) approved a new silicone gel breast implant for reconstruction as well as augmentation on Feb. 20, 2013.

The Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant is the fourth FDA-approved silicone gel-filled breast implant approved by the FDA. The Natrelle 410 is made by Allergan, Inc.

The approval is based on 7 years of information from a study that looked at 941 women with Natrelle 410 implants.

Most of the side effects and complications were similar to complications found in studies of other implants, including:

  • capsular contracture (tightening of the area around the implant)
  • infection
  • asymmetry (breasts appear uneven)
  • the need to have the implant removed

The researchers also found that some of the Natrelle 410 implants developed cracks in the gel (gel fracture). So far, this complication has only been seen in the Natrelle 410 implant.

The studies done so far didn’t compare the safety and effectiveness of the Natrelle 410 implant to other FDA-approved silicone gel-filled implants, so we can’t compare these new implants to previously approved implants.

The silicone gel in the Natrelle 410 implant contains more cross-linking, which means there are more bonds linking one silicone chain to another, compared to the other Natrelle implant. More cross-linking means the gel is firmer, but it’s not clear if there is any other clinical significance.

The FDA approval requires Allergan to conduct a series of studies to look at the long-term safety and effectiveness of the implants, as well as any risks that the implant may cause rare diseases. These studies must include:

  • 5 years of follow-up on about 3,500 women who received the Natrelle 410 implants before the FDA approval as part of Allergan’s continued access study
  • a 10-year study of more than 2,000 women who received Natrelle 410 implants after the approval to collect information on long-term complications
  • five studies looking for links between the Natrelle 410 implants and five rare diseases (rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer, lymphoma)
  • a study looking at women’s perceptions of the implant’s labeling
  • a study analyzing implants removed and returned to the manufacturer

If you're having mastectomy to remove breast cancer and want to know more about reconstruction, it's important to talk to your surgeon about your options BEFORE the mastectomy is scheduled. You may want to have a breast reconstruction surgeon help you evaluate your options. The breast reconstruction surgeon may be a different person than the surgeon scheduled to perform the mastectomy.

You have many reconstruction choices, including the type of reconstruction and the timing of the reconstruction. The stage of the breast cancer affects the best time to do reconstruction. If you're considering implant reconstruction, you may want to ask your doctor about the pros and cons of silicone gel and saline implants.

If you're having lumpectomy instead of mastectomy to treat breast cancer, it's still a good idea to talk to you doctor BEFORE the surgery about how your breasts will look afterward. You also may want to ask about the reconstruction options available if you're not satisfied with the way your breasts look after lumpectomy. Having the most complete information can help you feel better about yourself and your health after surgery.

Visit the Breastcancer.org Breast Reconstruction pages to learn more about the different types of breast reconstruction.

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