SILVER SPRING, Md.,
Sept. 14, 2018 /PRNewswire/ --
Choosing to obtain a breast implant, whether for augmentation or
reconstruction, is a deeply personal choice, from the initial
decision to undergo breast implant surgery to the size, material
and surface texture. These types of decisions should be discussed
between a patient and their provider in a transparent and balanced
way with clear information about the benefits and risks of the
breast implants and the procedure.
As a public health agency, we play an important role in ensuring
that patients seeking breast augmentation and breast reconstruction
have accurate information regarding the benefits and risks of
breast implants to make informed decisions on whether implants may
be right for them. Part of this role is to continuously monitor the
safety of devices, like implants, once they are being used in
patients, including examining adverse event reports that are
submitted to the agency as well as reviewing postmarket studies and
available scientific literature to enhance our understanding of a
device's benefit-risk profile.
The FDA has worked extensively to monitor, assess and take
action to protect patients with regard to breast implant safety
over the last several decades. We have regularly communicated about
risks associated with breast implants, such as capsular
contracture, implant rupture and breast implant-associated
anaplastic large cell lymphoma (BIA-ALCL). Part of our efforts in
continuously monitoring device risks include a responsibility to
communicate clearly about our perspective on the safety and
efficacy of the products we regulate when new information becomes
available. That is why today we're communicating about the
editorial response we published in the Annals of Surgery regarding
an external assessment of data that the researchers claim shows
evidence of an increased risk of certain connective tissue
conditions, such as rheumatoid arthritis and scleroderma, in
patients with breast implants. We commend the work of our peers in
studying the benefits and risks of breast implants. However, we
respectfully disagree with the authors conclusions. In our
editorial response, we note our concerns with significant
shortcomings with the study's methodology and how the data is
presented and concluded, including inconsistences in the data and
potential sources of bias. Because of these concerns, we urge the
public and healthcare community to view this external assessment's
conclusions with caution.
We understand that there are concerned patients with breast
implants who are experiencing a range of symptoms that may or
may not be related to their breast implants. We take these concerns
seriously and are committed to continuing to work with patient
groups, surgeons and scientists to further assess this issue. While
the agency continues to believe that the weight of the currently
available scientific evidence does not conclusively demonstrate an
association between breast implants and connective tissue diseases,
we respect studies like the ones published in Annals of
Surgery by our peers. These studies contribute to our
discourse on this topic, but more evaluation is required.
The FDA has in the past thoroughly assessed and reported the
results of the large post-approval studies that were used as a
basis for today's Annals of Surgery study. Our interim and final
findings were communicated in a 2011 Safety Update and on the FDA
post-approval study websites (for manufacturers Allergan and
Mentor) in 2015 and 2018. We noted at the time of the Safety Update
that breast implants are not lifetime devices and there is
insufficient information to show an association between silicone
gel-filled breast implants and connective tissue disease, breast
cancer or reproductive problems.
Our perspective today is based the decades of work we have done
to assess and communicate the benefits and risks of breast
implants. The steps we've taken date back to 1988, when, based on
emerging safety concerns, the FDA upclassified breast implants from
Class II (moderate risk) to Class III (high risk) devices requiring
manufacturers to submit a premarket approval application before the
device could be marketed. In 1992, the FDA expressed concern about
the available safety data for silicone implants and announced a
voluntary moratorium on all silicone implant sales in the U.S.
pending further review of safety information. This moratorium was
lifted in 2006 with the approval of new silicone implants that met
the FDA's standards for safety. As conditions of approval, each
manufacturer was required to conduct six post-approval studies to
further characterize the safety and effectiveness of their silicone
gel-filled breast implants and to answer additional scientific
questions about the long-term safety of breast implants that the
premarket clinical trials were not designed to answer. As part of
these post-approval studies, the FDA collected data from the
studies totaling nearly 100,000 patients. We communicated the
results of these post-approval studies in our 2011 report, which
noted that that breast implants are not lifetime devices and have a
reasonable assurance of safety and effectiveness when used as
labeled.
Also in 2011, the FDA was the first public health agency in the
world to communicate about the risks of BIA-ALCL, warning women
that the available information at the time indicated that there is
a risk for women with breast implants for developing this disease.
Since 2011, the FDA has regularly updated the information available
on our website regarding known BIA-ALCL cases, including deaths and
known risks.
Collectively, all of our actions demonstrate our commitment to
fulfilling our public health mission of ensuring patient access to
safe and effective products. As part of our recently released
Medical Device Safety Action Plan, we committed to streamlining and
modernizing how we implement postmarket actions to address device
safety issues to make our responses to risks more timely and
effective.
For instance, we have coordinated with the American Society of
Plastic Surgeons and the Plastic Surgeons Foundation to develop the
Patient Registry and Outcomes for Breast Implants and Anaplastic
Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILE),
which collects real world data regarding patients who have a
confirmed diagnosis of BIA-ALCL. The data collected from this
registry as well as medical literature, meetings with patient
advocates, and our own post-approval studies have contributed to
our understanding of BIA-ALCL and our communication updates to the
public regarding BIA-ALCL.
Additionally, we are working with multiple stakeholders to
facilitate the development of the National Breast Implant Registry
(NBIR) to provide a platform for evaluating real world data on the
safety and performance of breast implants that will greatly
contribute to helping us evaluate data from providers regarding
their patients with implants. We have heard from patients who are
concerned that their implants may be connected to other health
conditions, like chronic fatigue, cognitive issues and muscle pain.
While the FDA does not have evidence suggesting breast implants are
associated with these conditions, information from NBIR may help us
identify risk factors for complications, such as a patient's own
medical history, the specific type of operation, the type of
implant used, and concomitant use of other medical devices. Greater
information-gathering from a registry like NBIR will add helpful
information to the FDA's already extensive review of our own
medical device reports, review of medical literature, assessment of
post-approval studies, and meetings with patients.
The FDA remains committed to thoughtful, scientific,
transparent, public dialogue concerning breast implant safety and
effectiveness.
Last week, the FDA's multi-disciplinary breast implant team and
I had the opportunity to meet with a patient advocacy group focused
on breast implant related issues. This group provided their
perspectives as patients and researchers regarding breast implants
and identified several opportunities for improved understanding and
communication regarding breast implant risks and benefits. The
information they shared is valuable and important for us to be
aware of to be effective regulators serving the needs of
patients.
We appreciate feedback directly from patients and are looking
for more ways to incorporate the patient experience so that we
focus on the things that matter to them. In light of the growing
science regarding the benefits and risks of breast implants, we
intend to hold a public meeting of the General and Plastic Surgery
Devices Panel of our Medical Devices Advisory Committee in 2019 to
ensure that patients and health care providers continue to have
accurate, scientifically sound information about breast implant
safety and effectiveness, and to promote public dialogue on the
issue. Advisory committees like this one serve to provide the FDA
with independent advice from outside experts. This committee will
include several members from the medical community, academia and
industry and, importantly, patient representatives. These
individuals will engage in thoughtful discussion on currently
available scientific information. There will also be an opportunity
during the advisory committee meeting for members of the public to
provide comments regarding specific topics to the panel and the
FDA.
To date, our work has resulted in important new information
about breast implant risks being communicated to patients to ensure
they understand the benefits and risks of these devices. We respect
the work of those in the research community to add to the
thoughtful discussion on this topic. It highlights the importance
of continuing to monitor, assess and advance our understanding of
breast implant safety.
Dr. Binita Ashar is a general
surgeon and the director of the Division of Surgical Devices in the
FDA's Center for Devices and Radiological Health.
The FDA, an agency within the U.S. Department of Health and
Human Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines
and other biological products for human use, and medical devices.
The agency also is responsible for the safety and security of our
nation's food supply, cosmetics, dietary supplements, products that
give off electronic radiation, and for regulating tobacco
products.
Media Inquiries: Stephanie
Caccomo, 301-348-1956,
stephanie.caccomo@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
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SOURCE U.S. Food and Drug Administration