Status of Silicone Gel-Filled Breast Implants / FDA

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STATUS / AVAILABILITY OF IMPLANTS

Status of Silicone Gel-Filled Breast Implants

On April 10, 1991, FDA asked the manufacturers to submit evidence in a premarket approval (PMA) applicationthat silicone gel-filled breast implants were safe and effective. However, they were unable to provide FDA with this information. Without enough data on safety and effectiveness, FDA determined that silicone gel-filled breast implants could not be approved. Therefore, silicone gel-filled breast implants were removed from the open market. However, silicone gel-filled implants are available to women through the following FDA-approved studies:

an adjunct study an investigational device exemptions (IDE) study

An adjunct study is a study developed for continued availability of silicone-gel breast implants for a public health need. In April 1992, after a careful evaluation of the public health need, the alternatives to silicone gel-filled breast implants, and the risks, 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. For further information on enrolling into one of these studies, contact your doctor or the manufacturer (see Breast Implant Resource Groups section for manufacturer contact information).

Martha Murdock, DirectorNational Silicone Implant Foundation | Dallas Headquarters"Supporting Survivors of Medical Implant Devices"4416 Willow LaneDallas, TX 75244-7537

[Guest guest]

Well after reading this the only thing I can see that my sister would

have qualified for the gel implants she got being a first timer is

that she had pretty deformed breasts and extremely thin skin from a

large weight loss. I also think she feels that since I got so ill

from saline that maybe she will have better luck with the gels. So

far after what 3 months, she is fine, but then three months is

unusually fast to get ill.

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> Status of Silicone Gel-Filled Breast Implants

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> On April 10, 1991, FDA asked the manufacturers to submit evidence

in a premarket approval (PMA) applicationthat silicone gel-filled

breast implants were safe and effective. However, they were unable to

provide FDA with this information. Without enough data on safety and

effectiveness, FDA determined that silicone gel-filled breast

implants could not be approved. Therefore, silicone gel-filled breast

implants were removed from the open market. However, silicone gel-

filled implants are available to women through the following FDA-

approved studies:

>

> a.. an adjunct study

> b.. an investigational device exemptions (IDE) study

>

> An adjunct study is a study developed for continued availability of

silicone-gel breast implants for a public health need. In April 1992,

after a careful evaluation of the public health need, the

alternatives to silicone gel-filled breast implants, and the risks,

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. For further information on enrolling

into one of these studies, contact your doctor or the manufacturer

(see Breast Implant Resource Groups section for manufacturer contact

information).

>

> Martha Murdock, Director

> National Silicone Implant Foundation | Dallas Headquarters

> " Supporting Survivors of Medical Implant Devices "

> 4416 Willow Lane

> Dallas, TX 75244-7537