Summary of General and Plastic Surgery Devices Panel - April 11-13, 2005

Ilena Rose · medicine forum Guru Joined: 05 May 2005 Posts: 813

General and Plastic Surgery Devices Panel - April 11-13, 2005
(Summary)

The General and Plastic Surgery Devices Advisory Panel met on April
11-13, 2005 at the Hilton Washington DC North/Gaithersburg Hotel
located at 620 Perry Parkway in Gaithersburg, Maryland. The panel met
in order to provide advice and recommendations to the Agency for
premarket approval applications for Inamed Corporation’s
Silicone-Filled Breast Implants and Mentor Corporation’s Silicone
Gel-Filled Breast Implants.

The meeting began on April 11, 2005 with CDR Stephen P. Rhodes (Acting
Deputy Director, Division of General, Restorative & Neurological
Devices) giving the panel an update since the last panel meeting and
Dr. Miriam Provost (Acting Director, Division of General, Restorative
& Neurological Devices) summarizing the history of the regulation of
silicone gel-filled breast implants. The remainder of the April 11
session consisted of public testimony from over 140 individual
consumers, consumer groups, and professional societies.

On April 12, 2005, Inamed Corporation presented a summary of their
amended Silicone-Filled Breast Implant PMA data, which was reviewed
previously by the panel on October 13-14, 2003, and FDA presented
their review of the data. The presentations highlighted the results
obtained from an explanted implant retrieval study and an additional
year of patient follow-up data on silent rupture. With respect to the
clinical trial data, both the sponsor and the FDA focused their
presentations on the clinical data provided in the Core Study, which
is a 10-year open label, prospective study involving augmentation,
reconstruction and revision patients that has completed 3-year
follow-up and has collected some 4-year follow-up data. Safety was
assessed by looking at rates of complications for all subjects and MRI
data on a limited cohort of patients to evaluate asymptomatic device
rupture. Effectiveness was assessed by the examination of breast
dimensions, patient satisfaction and Quality of Life measures. The
study enrolled 494 patients undergoing breast augmentation with 987
devices, 221 patients undergoing breast reconstruction with 361
devices and 226 patients undergoing implant revision with 432 devices.
The panel engaged in an in-depth discussion of the PMA data and the
FDA questions, which included inquiries regarding the adequacy of the
characterization of the rupture data, the adequacy of the data to
evaluate the consequences of rupture, the adequacy of Inamed
Corporation’s labeling in the discussion of methods for screening
silent rupture, intracapsular and extracapsular rupture and
consequences of extracapsular gel.

The discussion of the data and FDA questions was followed by
approximately an hour of public participation during which 14
individual consumers, consumer groups, and professional societies
provided testimony before the panel. Following the public testimony,
the panel heard a brief summation by Inamed Corporation and then
voted. The Inamed Corporation PMA for Silicone-Filled Breast Implants
(P020056) was recommended as “not approvable” by a 5 to 4 vote. Among
the reasons given by the panel for their vote was the need for
additional patient follow-up data and the inadequate performance of
the Style 153 device.

On April 13, 2005, Mentor Corporation presented a summary of their
Silicone Gel-Filled Breast Implant PMA data and FDA presented their
review of the data. The presentations highlighted the results of
preclinical testing and clinical testing. The preclinical testing
included chemical, toxicological and mechanical characterizations. The
clinical testing summary included safety and effectiveness data. With
respect to the clinical trial data, both the sponsor and the FDA
focused their presentations on the clinical data provided in the Core
Study, which is a 10-year open label, prospective study involving
augmentation, reconstruction and revision patients that has completed
2-year follow-up and has collected some 3-year follow-up data. Safety
was assessed by looking at rates of complications for all subjects and
MRI data on a limited cohort of patients to evaluate asymptomatic
device rupture. The study enrolled 551 patients undergoing breast
augmentation, 252 patients undergoing breast reconstruction and 226
patients undergoing implant revision. Also, 420 of the total patient
enrollment were also enrolled into the MRI screening for silent
rupture. The panel engaged in an in-depth discussion of the PMA data
and the FDA questions, which included inquiries regarding the adequacy
of the characterization of the rupture data (including silent
rupture), the adequacy of the data to adequately evaluate the
consequences of rupture, the adequacy of Mentor Corporation’s labeling
in the discussion of methods for screening silent rupture,
intracapsular and extracapsular rupture and consequences of
extracapsular gel.

The discussion of the data and FDA questions was followed by
approximately an hour of public participation during which 11
individual consumers, consumer groups, and professional societies
provided testimony before the panel. Following the public testimony,
the panel heard a brief summation by Mentor Corporation and then
voted. In the first vote, the motion for “not approvable” was defeated
by a 7 to 2 vote. In a second vote, the Mentor Corporation PMA for
Silicone Gel-Filled Breast Implants (P030053) was recommended as
“approvable with conditions” by a 7 to 2 vote. Among the conditions of
approval were, a requirement for training and certification of Board
Certified and Board Eligible Plastic Surgeons before they could
receive devices to implant, a requirement for Mentor Corporation to
complete their 10-year core study and for the FDA to convene a panel
meeting in 5 years to review the post-approval study data, the
requirement for Mentor Corporation to establish an independent Data
Safety Monitoring Committee as outlined in the FDA guidance document
to periodically review the post-approval data collection and results,
and the requirement that the company attempt to obtain follow-up
information on patients that had their implants taken out and not
replaced.

Contact: David Krause, Ph.D., Executive Secretary, 301-594-3090, x141

Transcripts may be purchased from:
Neal R. Gross & Company
1323 Rhode Island Avenue, NW
Washington, DC 20005
(202) 234-4433
Or
The Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
301-827-6500 (voice) or 301-443-1726 (FAX)

Under normal circumstances, panel summary minutes are available 60-90
days post meeting. Summaries are also available on the CDRH web site:
http://www.fda.gov/cdrh/panel/

Nana Weedkiller · medicine forum beginner Joined: 29 Apr 2005 Posts: 26

Ilena, Dahling, are you going to answer my question?

"Ilena Rose" <ilena@NOSPAMMINhotmail.com> wrote in message
news:89c071tj4hhepn77hhoccq5uvm36rnsk2l@4ax.com...

Ilena Rose · medicine forum Guru Joined: 05 May 2005 Posts: 813

On Fri, 29 Apr 2005 17:30:06 GMT, "Nana Weedkiller"
<nanaweedkiller@yahoo.com> quacked:

www.BreastImplantAwareness.org/Myrl.html#yahoo
see 3 versions of Quack Willa ... Myrl Jeffcoat's choice of a
"legitimate" breast implant support leader.

Ilena Rose · medicine forum Guru Joined: 05 May 2005 Posts: 813

On Fri, 29 Apr 2005 17:30:06 GMT, "Nana Weedkiller"
<nanaweedkiller@yahoo.com> quacked:

www.BreastImplantAwareness.org/Myrl.html#yahoo
see 3 versions of Quack Willa ... Myrl Jeffcoat's choice of a
"legitimate" breast implant support leader.

Does the Air Force know you promote Quacks Teddy?

Myrl · medicine forum beginner Joined: 29 Apr 2005 Posts: 13

Ilena-
Please provide proof I have ever labeled Willa as a breast implant
support leader!

Nana Weedkiller · medicine forum beginner Joined: 29 Apr 2005 Posts: 26

"Ilena Rose" jim lord, porno poppy zaffuto squeeked in message
news:8js471pr4o1eubddiupbfea08kl9771bkk@4ax.com...

Google