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History of the FDA and Breast Implants
Breast implants were first sold in the U.S. in the 1960s, at a time
when there was no government regulation of medical devices, including
implants. When a law was passed giving the FDA that authority in
1976, the agency was overwhelmed with an enormous backlog of devices
that needed to be evaluated. Most devices were allowed to remain
on the market until those reviews were completed, and breast implants
were generally considered a much lower priority than potentially
life-saving devices such as heart valves and shunts.
Scientists and physicians started expressing strong concerns about
the safety of silicone breast implants in the late 1970’s,
and their concerns were discussed at a 1978 FDA advisory committee
meeting. By the early 1980’s, most of the risks that eventually
led to the removal of silicone gel implants from the market were
known or suspected, and included in a proposed rule in the Federal
Register.1
Finally, in 1988 the FDA finalized the proposed rule. At an FDA
advisory committee meeting, the warnings of earlier years had become
more urgent, and a lawyer, a former Dow engineer, and other experts
testified that they had seen protected court documents indicating
that manufacturers were hiding safety information from FDA and the
public. Several women described their own terrible experiences with
implants.
The November 1988 FDA advisory panel on breast implants expressed
considerable concern about their safety. They recommended that the
FDA establish a national registry of women who have breast implants.
This was opposed within FDA as too expensive and unlikely to be
useful, and as setting a precedent that might cause problems for
the agency. Moreover, the FDA was concerned about the viability
of a registry because the American Society of Plastic and Reconstructive
Surgeons did not support it.
The panel also recommended a mandatory program to inform the public
of potential risks of breast implants, possibly including informed
consent prior to surgery. However, it was decided that the regulations
required for a mandatory program would be so strongly opposed by
the plastic surgeons and manufacturers, that it was more practical
to develop a voluntary program instead. At the January 1989 panel
meeting, the FDA announced plans to develop a brochure and videotapes
to educate women about the risks of implants prior to surgery.
The brochures and videotape were to be distributed voluntarily in
the offices of plastic surgeons. The educational materials were
to be developed by consensus by a diverse group of 23 individuals
representing consumer organizations, manufacturers, and health professionals;
each representative was given the authority to veto any decision.
Because of disagreement within this group about what the materials
should say, the brochures and videotapes were never completed.
By 1990, almost one million women had breast implants and the numbers
were increasing substantially, but the FDA had not yet required
the manufacturers to evaluate their safety and no empirical studies
had been published regarding their effects on human health.
Silicone Gel-Filled Implants
In 1991, pressured by Congressional hearings in the House of Representatives
chaired by Rep. Ted Weiss (D-NY) and media reports of illness and
complications, the FDA finally required the manufacturers of silicone
gel breast implants to submit safety studies. FDA scientists
pointed out that the studies were inadequate -- they included few
women, the women had implants for very short periods of time, and
many women were lost to follow-up. The law requires that products
be proven safe and effective in order to be sold in the United States,
but the FDA could not conclude whether the implants were safe or
effective because of the shortcomings of the research. (There is
no requirement that products be proven unsafe to keep them off the
market.)
However, there was enormous pressure to keep breast implants on
the market from manufacturers, plastic surgeons, and their Congressional
representatives. In 1992, as a compromise, silicone gel breast implants
were allowed to remain available as a "public health need,”
with the FDA limiting their availability to clinical trials, primarily
for women who have mastectomies, breast deformities, or to replace
a broken gel implant. Any woman who has had implant surgery with
silicone gel implants since 1992 is required to be regularly evaluated
by her plastic surgeon as part of the study. Currently, a limited
number of women can also receive gel implants for first-time augmentation
as part of clinical trials.
In January, 2004, the FDA announced it would not approve silicone gel breast implants, because of the lack of long-term safety data. However, in April 2005, the FDA held a public meeting to once again consider approval of silicone gel breast implants, with almost the same data that they had rejected the year before. In November 2006, the FDA announced that they were approving silicone gel breast implants made by two manufacturers, Allegan and Mentor. However, the approval was on the condition that the implant makers each study 40,000 women with silicone gel implants for 10 years. In addition, the FDA stated that silicone breast implants were not approved for women under the age of 22.
Saline-Filled Breast Implants
In 2000, the FDA reviewed the safety of saline-filled breast
implants for the first time. Saline implants have a silicone
outer envelope and are filled with salt water. The FDA required
studies of local complications, such as pain, infection, hardening,
and the need for additional surgery. They did not require studies
of diseases or other systemic health problems. Despite extremely
high complication rates during the first three years (approximately
three out of four reconstruction patients and almost half of first-time
augmentation patients), the FDA approved saline implants. As part
of the approval process, the FDA made information about the risks
of breast implants more available. A consumer handbook and a brochure
with photographs of common complications are available online at
www.fda.gov/CDRH/breastimplants.
1 The FDA's Regulation of Silicone Breast Implants: Staff
Report Prepared by the Human Resources and Intergovernmental Relations
Subcommittee of the House Government Operations Committee, December
1992.
FDA Materials
• Photographs
of Breast Implant Complications
• FDA's
Consumer Handbook on Breast Implants - 2004
Selected Public Testimony at FDA Advisory Panel meeting
on Silicone Breast Implants, April 2005
Testimony of Diana Zuckerman,
Ph.D.
Testimony of Ed Brent
Testimony of Dawn Miller
Testimony of Shannon
Scott
Testimony of Linda MacDonald
Glenn
Testimony of Audrey Sheppard
Testimony of Judy Norsigian
Testimony of Marcy Gross
Testimony of Claudia
Miller, MD
Complete Transcript of FDA Advisory Panel meeting on Silicone
Gel Breast Implants, April 2005
April
11, 2005 Transcript [Morning and Afternoon Public Comment]
(Word)
April 11, 2005 Transcript [Evening Public Comment]
(Word)
April 12, 2005 Transcript [Inamed Only] (Word)
April 13, 2005 Transcript [Mentor Only] (Word)
FDA summary of Inamed data for April 12, 2005 FDA advisory
panel meeting
http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_tab-1_fda-Inamed
Panel Memo.pdf
FDA summary of Mentor data for April 13, 2005 FDA advisory
panel meeting
http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_Tab-1_fda-Mentor
Panel Memo.pdf
FDA PowerPoint presentation of data on Mentor and Inamed
Silicone Breast Implants, April 2005
http://www.fda.gov/ohrms/dockets/ac/05/slides/2005-4101s1.htm
Additional information about Inamed and Mentor silicone
gel breast implants from the April 11-13 FDA advisory panel meeting
http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1.htm
Testimony Before the FDA in 2003
Testimony of Diana Zuckerman,
Ph.D.
October 15, 2003
Testimony of Anne Kasper,
Ph.D.
October 14, 2003
Testimony of Sherry Henderson
October 14, 2003
Testimony of Suzy Cunningham
October 14, 2003
Testimony of Marcy Gross
October 14, 2003
Testimony of Becky S.
October 15, 2003
Testimony of Ruby Rahn
October 15, 2003
Testimony of Susan Pope
Helman, Ph.D.
October 15, 2003
Research Findings and Transcript of FDA Meeting on Silicone Breast
Implants, October 14-15, 2003
www.fda.gov/ohrms/dockets/ac/cdrh03.html#GeneralandPlasticSurgery
FDA PowerPoint Slides of Inamed Complications with Silicone Breast Implants, October 14-15, 2003
http://www.fda.gov/ohrms/dockets/ac/03/slides/3989s1.ppt#49
Testimony Before the FDA in 2002:
Testimony of Diana Zuckerman,
Ph.D.
July, 2002
Testimony of Jae Hong Lee, MD,
MPH
July, 2002
Testimony of Cynthia Pearson
July, 2002
Research by FDA Scientists
• Click here
for articles by FDA Scientists
Transcript of FDA March 2000 Meeting on Saline Implants
• To read the exact transcript of the 3-day FDA Advisory Panel
meeting on Saline Breast Implants, click the day you want to read
first. It may take some time to view or download the file:
March
1, 2000
March 2, 2000
March 3, 2000
Congressional Report
• The FDA's Regulation of
Silicone Breast Implants: A Staff Report Prepared by the Human
Resources and Intergovernmental Relations Subcommittee of the House
Government Operations Committee, December 1992.
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