Silicone Gel Implant FDA
Update
November 17, 2006
Arlington Heights, Ill. (November
17, 2006) – The American Society for Aesthetic Plastic Surgery and The American
Society of Plastic Surgeons, the two largest plastic surgery membership
organizations, applaud the FDA's decision today to approve (manufacturer's)
silicone breast implants and return these devices to the U.S. market. This
decision comes 14 years after the FDA restricted access to the silicone implants
because of safety concerns.
“This is a great day for American women and the plastic surgeons who care for
them,” said Roxanne Guy, MD, ASPS president. “Silicone breast implants have been
scrutinized more than any medical device, and we applaud the FDA for making its
well thought-out decision and allowing American women to make informed choices
about their health care.”
Today's FDA decision follows a lengthy process in which the agency sent
“approvable with conditions” letters to the two silicone breast implant
manufacturers in the second half of 2005. The approvable letter stipulated a
number of conditions that the manufacturers needed to satisfy in order to
receive FDA final approval to market and sell silicone breast implants in the
United States. These letters came after an FDA advisory panel hearing in April
2005, in which the panel heard more than 20 hours of data presentations from the
manufacturers and public comment.
“Plastic surgeons are committed to patient safety and education,” said James
Stuzin, MD, ASAPS president. “It is clear that the agency has carefully
evaluated the data presented by the manufacturers, as well as the testimony of
physicians, patients and advocacy groups and has made a thoughtful decision to
give our patients the access to silicone gel breast implants that women in 60
countries around the world have.”
The specialty of plastic surgery supports a woman's right to make informed
personal choices about her health care based on all the available and accurate
information about cosmetic plastic surgery, breast augmentation and breast
reconstruction. Cosmetic plastic surgery is serious surgery. It requires a
complete medical consultation with a plastic surgeon certified by the American
Board of Plastic Surgery who will fully inform a potential patient about the
risks and benefits of surgery.
Approximately 300,000 women chose breast augmentation in 2005, according to
ASAPS and ASPS statistics. Nearly 58,000 women had breast reconstruction in
2005, according to ASPS. Both breast augmentation and reconstruction have been
proven in numerous studies to have psychological and physical benefits for women
who choose these procedures.
FDA PANEL
Wednesday April 13, 2005
6:00 PM EST: Panel Says Mentor Implants
Approvable With Conditions
Members of the General and Plastic Surgery Devices Panel of the Medical
Devices Advisory Committee voted seven to two that Mentor Corporation’s
silicone breast implant premarket approval application is recommended to the
Food and Drug Administration as approvable with conditions. Many of the
conditions are already components of the company’s proposed post-approval
commitment plans.
Prior to voting, panel members answered specific FDA questions relating to
the silicone breast implants. A consensus was reached regarding the adequacy of
the 3-year core study data with several members commenting that the study was
well-designed and the data well-presented. Panel members also discussed rupture
frequency and local health consequences of rupture.
The panel also discussed labeling issues including MRI frequency suggestions
and a recommendation that ruptured implants should be removed. Extensive
discussion followed on the stringent surgeon training and certification program
Mentor Corporation will implement upon device approval. Suggestions for
post-approval study design, methods, and ongoing data collection were made.
A majority of panel members stated that the data presented today offered
reasonable assurance of the safety of the silicone breast implant with many
reporting they felt safety was assured for 10 years after implantation. A
majority of panel members also believed that the device is effective, especially
with regard to the positive quality of life and patient satisfaction data
presented earlier. Panel members said that assurance of safety and efficacy
exists when the silicone breast implant is used for augmentation,
reconstruction, or revision procedures.
A brief public testimony session was held prior to the panel vote with
several breast cancer advocates and physicians emphasizing the importance of
making a silicone breast implant available as an option for informed women and
their surgeons. Patients who have received silicone breast implants also
testified and a majority expressed their satisfaction and urged the panel to
make them available to more women.
Panel members voting that the Mentor silicone breast implants are approvable
with conditions included Joseph LoCicero, III, MD; Barbara R. Manno, PhD;
Stephen Li, PhD; A. Marilyn Leitch, MD; Cheryl A. Ewing, MD; Michael J. Miller,
MD; and Leigh F. Callahan, PhD. Members opposing the approvable with conditions
recommendation were Brent A. Blumenstein, MD and Amy E. Newberger, MD.
The first of the conditions panel members asked the FDA to consider was a
requirement for hand-on training or the equivalent within a documented
instructional program for physicians intending to place the silicone gel
implants, along with a requirement that those implanting the devices be
board-certified, eligible plastic surgeons. The panel members were unanimously
in favor of this requirement and Mentor experts had earlier detailed the
certification program they intend to have in place within 90 days of product
approval.
Panel members also unanimously voted in favor of requiring the company to
continue 10-year core study data collection as proposed in its post-approval
plan, additionally asking that a panel meeting convene 5 years from now for
review of the continuing data.
Unanimous votes were also given to requirements that all of the post-approval
commitments proposed by Mentor become conditions, that a patient-education
program with an informed consent separate from that needed for the surgery be
conducted, that an independent data monitoring committee be added to the ongoing
core study, and that the core study design be amended to include quality-of-life
and symptom follow up on patients having implants removed.
Panel members voted that the FDA consider making the silicone gel implants
tracked devices ad that the company maintain a voluntary patient registry. A
condition that proposed device labeling recommend patients have an MRI 5 years
after implantation and every 2 years thereafter with consideration of implant
removal if a silent rupture is detected also passed.
2:00 PM EST: Advisory Committee
Begins Consideration of Mentor Implant
Mentor Corporation presented silicone breast implant efficacy and safety data
to the General and Plastic Surgery Devices Panel of the Medical Devices Advisory
Committee this morning. The presentations were followed by an extensive review
of the data by Food and Drug Administration experts.
Results of a 1,007-patient core study were presented including analyses of
3-year data for augmentation, reconstruction, and revision patients.
Complication rates were addressed as were follow up MRI findings for 372 of the
patients and causes of rupture occurring during a 12-year period after device
implantation were detailed. No extracapsular ruptures occurred in core
study patients.
The biocompatibility of the Mentor silicone device was reviewed and
presenters discussed the characteristics of the silicone gel and predicted
longer-term life of the device. This was followed by a detailed analysis of the
lower potential exposure to silicone, metals and other substances associated
with the implant.
Presentation of the silicone breast implant efficacy included extensive
quality of life assessment data showing that implant patients were highly
satisfied with having had the surgery.
FDA experts first reviewed the preclinical testing of the implant device,
focusing on the modes and causes of rupture, fatigue testing, silicone gel bleed
and cohesion, and shelf life. An overview of implant chemistry was given and
analyzed the implant shell layers, patch assembly, silicone gel composition and
cohesiveness.
The panel also heard FDA testimony on the pharmacokinetics and testing of the
Mentor silicone breast implant, the adjunct study and information from a
comparative literature review.
This afternoon panel members will discuss FDA questions regarding the Mentor
device and will vote on whether to recommend approval.
Tuesday April 12, 2005
9:00 PM EST: Panel Recommends
Nonapprovable Status
Members of the General and Plastic Surgery Devices Panel of the Medical
Devices Advisory Committee voted five to four to recommend to the Food and Drug
Administration that Inamed’s silicone breast implants are nonapprovable.
Panel members voting for nonapprovable status included Brent A. Blumenstein,
MD; Amy E. Newberger, MD; Joseph LoCicero, III, MD; Barbara R. Manno, PhD; and
Stephen Li, PhD. Members opposing the nonapprovable vote included A. Marilyn
Leitch, MD; Cheryl A. Ewing, MD; Michael J. Miller, MD; and Leigh F. Callahan,
PhD.
However, panel members asked the FDA to encourage Inamed to continue
collecting longer-term data related to all of their devices, particularly the
dual-lumen breast implant, device 153. Additional data on quality of life
measures and causes of device rupture were also recommended. Several panel
members expressed optimism that in the future, women and their physicians will
have more choices when deciding on an appropriate implant.
The vote followed a lengthy discussion among panel members in response to
five questions posed by the FDA. During the discussion, the panel was able to
reach a consensus on short-term rupture rates, localized health consequences of
rupture, proposed screening recommendations to detect silent rupture, and
removal recommendations for ruptured implants. The frequency of extracapsular
ruptures, potential silicone gel migration, and related literature reports were
discussed and focused on offering physicians adequate information with
which to provide patients an opportunity for informed consent. The possibility
of specifically defining the expected lifetime of a silicone breast implant was
addressed.
The panel also agreed that implant safety did not differ between augmentation
and reconstructive uses.
Panel members and the FDA will reconvene tomorrow morning to consider data
presentations from Mentor Corporation’s silicone breast implants.
