Silicone Gel-Filled Breast Implants

Cosmetic Surgery Magazine article, posted 2005

In 1991 manufacturers of implants were asked to submit to the FDA evidence that silicone gel-filled implants were safe and effective. The FDA determined there was not enough evidence and removed them from the open market.

However, many women in the US still undergo breast augmentation using silicone implants through FDA inclusion criteria. The FDA has approved two studies allowing participating women to use silicone gel-filled implants. These studies are an adjunct study and an investigational device exemptions (IDE) study.Silicone Gel-Filled Breast Implants

Outlined below are the FDA criteria for these studies:

"An adjunct study is a study developed for continued availability of silicone gel-filled breast implants for a public health need. The FDA concluded that silicone gel-filled breast implants should continue to be available for women seeking breast reconstruction or revision of an existing breast implant.

Accordingly, the adjunct study was developed to make silicone gel-filled breast implants available for reconstruction and revision patients and to collect short-term complication data. Eligible women include those who have had breast cancer surgery, a severe injury to the breast, a birth defect that affects the breast, or a medical condition causing a severe breast abnormality. Additionally, those who need to have an existing implant replaced for, medical reasons, such as rupture of the implant, are also eligible. Women who want silicone gel-filled implants for breast augmentation (cosmetic reasons) cannot be enrolled in the adjunct studies. According to the adjunct study protocols, each woman will be followed for at least five years.

An IDE study is a clinical study that must be reviewed and approved by FDA to help assure that the resulting data will be meaningful and that patients will not be exposed to unreasonable risks. Under the law, FDA cannot acknowledge the existence of any study conducted under the IDE unless the manufacturer publicly announces the existence of the study. Likewise, FDA cannot release the results of studies conducted under an IDE unless the manufacturer has made the data publicly available. Generally, these IDE study data are used as the basis for a future application to market the device.

Women participating in an IDE study would receive their implants for the uses described in the study protocol/plan. Each woman who participates in an IDE study must give informed consent, and an Institutional Review Board (IRB) must oversee the study. An IRB is composed of scientists, health professionals, and community members who do not have a bias as to the outcome of the study.To date, both Mentor Corporation and McGhan Medical have adjunct and IDE studies approved by FDA

To date, both Mentor Corporation and McGhan Medical have adjunct and IDE studies approved by FDA. For further information on enrolling into one of these studies, contact your doctor or the manufacturer.

Who’s a candidate for silicone implants

Women may receive these implants as part of a clinical study:

  • For reconstruction after mastectomy
  • To even out appearance if a woman has a congenital condition where one side of the chest fails to develop
  • To replace a silicone implant that is removed for medical reasons (e.g. rupture)