Saline-Filled Breast Implants: Joint Position Statement from the American Society for Aesthetic Plastic Surgery (ASAPS) and the American Society of Plastic Surgeons (ASPS)

Introduction

The American Society for Aesthetic Plastic
Surgery (ASAPS) and the American Society
of Plastic Surgeons (ASPS) are offering
testimony on saline-filled breast implants
at the U.S. Food and Drug Administration's
(FDA's) public advisory committee meeting
of the General and Plastic Surgery Devices
Panel July 9, in Gaithersburg, MD.

ASAPS and ASPS believe that the weight
of current scientific evidence supports
the FDA's approval and continued oversight
of these devices. Both organizations support
a woman's right to choose implants for breast
reconstruction or enlargement as well as
her right to be fully informed of both the
risks and benefits of implant surgery.

History

The FDA's General and Plastic Surgery Devices
Panel is continuing an ongoing regulatory
process of saline-filled breast implants,
a process that began in 1988.

The two manufacturers of approved saline-filled
breast implants, also called saline inflatable
breast implant devices, are presenting an
update on postmarket information to the
committee as previously requested.

Saline-filled breast implants have been
available since the late 1960s. Like most
medical devices, they have evolved in both
design and production.

The FDA Medical Device Amendments were
enacted in 1976 by Congress, giving the
FDA the authority to regulate medical devices
such as breast implants, which were already
on the market. In 1988 the FDA classified
all breast implants as class III medical
devices requiring strict controls for safety
and effectiveness.

In May 2000 the FDA approved, with conditions,
premarket approval applications (PMAs) for
saline-filled breast implants manufactured
by Mentor Corporation and McGhan Medical
(now Inamed Aesthetics).

Issues that have been raised related to
the safety of saline-filled breast implants
have been addressed through scientific studies.
Implants today are more reliable than implants
manufactured in earlier years, though no
implant is guaranteed to last a lifetime.
Breast implants are like other implants
(for the knee, hip, etc.), which represent
a foreign element in the body. There is
an expected reoperation rate.

Scientific Data

  • In May 2000, the FDA gave its official
    approval to two manufacturers of saline-filled
    breast implants, finding their implants
    both safe and effective for breast augmentation
    and reconstruction.
  • Saline-filled implants provide excellent
    results for most women, and the popularity
    of breast augmentation surgery appears to
    be ever increasing, with over a million
    women choosing breast augmentation in the
    last decade.
  • Ongoing research continues to document
    positive outcomes in relation to saline-filled
    breast implants. For example, all information
    indicates that women with implants are able
    to breast feed with the same degree of comfort
    and/or difficulty experienced by women without
    implants.
  • Published studies in peer-reviewed medical
    journals have found no persuasive evidence
    of a causal association between breast implants
    and any type of cancer.
  • Studies have documented the high patient
    satisfaction rate, with the vast majority
    of breast implant patients saying they would
    make the same choice again.
  • A multi-site prospective outcome study
    on patient satisfaction following aesthetic
    surgery is underway. This study will provide
    additional data on this critical subject.



Saline Implants: Potential Risks

Besides deflation, the major risks associated
with saline-filled breast implants are local
complications such as altered sensation,
breast pain, wrinkling, asymmetry, and capsular
contracture. Capsular contracture is the
tightening of natural scar tissue around
the implant, which can cause breast firmness.
The occurrence of capsular contracture is
unpredictable and, sometimes, severe. Several
of these local complications may result
in the need for reoperation.

A theoretical concern associated with breast
implants is the possibility that the devices
may interfere with the early detection of
breast cancer through mammography. Mammography
of the augmented breast requires special
techniques and additional x-ray views. However,
a study published by the University of Southern
California of breast cancer diagnosis and
survival among 3,182 women with breast implants
in Los Angeles County, showed the stage
of cancer diagnosis was virtually identical
to that of all breast cancer patients in
LA County. Moreover, the five-year survival
rate was consistent with rates established
by the National Cancer Institute. Additionally,
there is no evidence that implants cause
breast cancer. In fact, two major studies
have shown a lower than expected rate in
women with breast implants.

Informed Consent

ASAPS and ASPS believe that informed consent
is crucial to successful breast implant
surgery. Informed consent results when patients
are provided with all the facts and information
necessary to make an educated decision to
proceed with a medical treatment or surgical
procedure. Full informed consent is in the
best interests of both patients and physicians.

Conclusion

ASAPS and ASPS support the FDA in its effort
to ensure patients receive safe and effective
medical devices. Patient safety is the primary
concern of all plastic surgeons. Scientific
studies on the safety of breast implants
support the more than 30-year clinical experience
that saline-filled breast implants are safe
medical devices. ASPS and ASAPS support
additional research on saline-filled breast
implants.

Women who choose breast implant surgery
are often made to feel that the procedure
is unnecessary and poses undue risk. Yet
studies confirm that the vast majority of
women who choose breast augmentation experience
improvements in body image, self-esteem
and quality of life.

Women must have the right to choose implant
surgery with full informed consent, which
means complete and up-to-date information
regarding potential risks and benefits.
Additionally, women who have undergone breast
augmentation by board-certified plastic
surgeons report that they are being adequately
informed about the risks and benefits of
breast implant surgery and that their surgeons
are responding to their questions and needs.

The American Society for Aesthetic Plastic
Surgery (ASAPS) is the leading organization
of board-certified plastic surgeons who
specialize in cosmetic surgery of the face
and body. The American Society of Plastic
Surgeons (ASPS) is the largest organization
of board-certified plastic surgeons in the
world. Members of both organizations are
certified by the American Board of Plastic
Surgery.

About ASAPS
The American Society for Aesthetic Plastic Surgery (ASAPS), is recognized as the world’s leading organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body.  ASAPS is comprised of over 2,600 Plastic Surgeons; active members are certified by the American Board of Plastic Surgery (USA) or by the Royal College of Physicians and Surgeons of Canada and have extensive training in the complete spectrum of surgical and non-surgical aesthetic procedures. International active members are certified by equivalent boards of their respective countries. All members worldwide adhere to a strict Code of Ethics and must meet stringent membership requirements.

WE ARE AESTHETICS.

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