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FDA Breast Implant Consumer Handbook - 2004
STATUS / AVAILABILITY
Saline-Filled Breast Implants
Prior to August 1999, saline-filled breast implants were sold on the market either as preamendments devices (they were on the market prior to May 1976) or as 510(k)-cleared devices. In August 1999, FDA issued a regulation that required that all saline-filled breast implants be PMA-approved to be sold on the market. However, those companies that had a preamendments or 510(k)-cleared saline-filled breast implant and submitted their PMA within 90 days of the August 1999 regulation were allowed to keep their device on the market until the final decision/actions were made in May 2000. Since May 2000, a saline-filled breast implant must be PMA-approved to be sold on the market.3
On May 10, 2000, FDA approved Mentor Corporation's and Inamed Corporation's (formerly McGhan Medical) saline-filled breast implant PMAs. As of the date of this handbook, these are the only two companies with PMA-approved saline-filled breast implants.
| Except for two PMA-approved saline-filled breast implants, all other saline-filled breast implants are considered investigational devices because they are not PMA- approved. For a woman to receive an investigational saline-filled breast implant in the U.S., she must enroll in an investigational device exemption (IDE) study. |
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. IDE studies may include augmentation, reconstruction, and/or revision patients. The number of patients and the number of sites are limited in IDE studies. In addition, each woman who participates in an IDE study must give informed consent.4 The safety and effectiveness data collected in an IDE study are used to support a future PMA.
Silicone Gel-Filled Breast Implants
Prior to 1991, silicone gel-filled breast implants were sold on the market as either preamendments devices (they were on the market prior to May 1976) or as 510(k)-cleared devices. In April 1991, FDA issued a regulation that required that all silicone gel-filled breast implants be PMA-approved to be sold on the market. However, those companies that had a preamendments or 510(k)-cleared silicone gel-filled breast implants and submitted their PMA within 90 days of the April 1991 regulation were allowed to keep their device on the market until the final decision/actions were made in April 1992. Since April 1992, a silicone gel-filled breast implant must be PMA-approved to be sold on the market.
| As of the date of this handbook, no company has PMA approval for a silicone gel-filled breast implant. Therefore, all silicone gel-filled breast implants are considered investigational. For a woman to receive a silicone gel-filled breast implant in the U.S., she must enroll in an IDE study or an adjunct study. |
An IDE study is described in the Saline-Filled Breast Implants section above.
An adjunct study is different from the IDE study in terms of its purpose and study design. In April 1992, FDA determined that the silicone gel-filled breast implant PMAs submitted in 1991 did not include adequate safety data to support PMA approval. However, FDA believed that there was a public health need to have breast implants available for reconstruction and revision patients. Therefore, companies that had not withdrawn their PMAs prior to the April 1992 decision were given the opportunity to submit an adjunct study protocol, for FDA approval, to address the public health need. Only Mentor Corporation and Inamed Corporation received approvals for their adjunct studies.
Adjunct studies are limited to reconstruction and revision patients. Women who want silicone gel-filled implants for augmentation (cosmetic reasons) cannot be enrolled in an adjunct study. New reconstruction and revision patients are continuously being enrolled in the adjunct studies because there is no limit on the number of patients or the number of sites. Each woman who participates in an adjunct study must give informed consent.5 The safety data collected in an adjunct study are used as supplemental data to support a future PMA.
Alternative Breast Implants
All alternative breast implants are reviewed through the PMA process because they are post-amendments devices (not on the market prior to May 1976). As of the date of this handbook, there are no alternative breast implants approved for marketing. Therefore, all alternative breast implants are considered investigational devices. To receive an alternative breast implant in the U.S., you must enroll in an IDE study (see the Saline-Filled Breast Implant section above).
3A completed product development protocol (PDP) application is an alternative to an approved PMA for all types of breast implants. However, to date, no companies have pursued the PDP route to marketing for these devices; thus, PDPs are not discussed further in this handbook.
4Note that the informed consent document required for a patient to participate in an IDE study should not be confused with a standard surgical consent form that a hospital requires to be signed by any surgical patient.
5Note that the informed consent document required for a patient to participate in an adjunct study should not be confused with a standard surgical consent form that a hospital requires to be signed by any surgical patient.
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