ATDEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR DEVICES AND RADIOLOGIC HEALTH
GENERAL AND PLASTIC SURGERY DEVICES
PANEL
OF THE MEDICAL DEVICES ADVISORY
COMMITTEE
Wednesday, October 15, 2003
7:30 a.m.
Gaithersburg Marriott Hotel
9751 Washington Blvd.
Gaithersburg, Maryland
P A R T I C I P A N T S
Thomas V. Whalen, M.D., Acting Panel Chairperson
David Krause, Ph.D., Executive Secretary
VOTING MEMBERS:
Brent A. Blumenstein, Ph.D.
Phyllis Chang, M.D.
Michael A. Choti, M.D.
Ann Marilyn Leitch, M.D.
Michael J. Miller, M.D.
Amy E. Newburger, M.D.
CONSUMER REPRESENTATIVE:
Alisa M. Gilbert
INDUSTRY REPRESENTATIVE:
Debera M. Brown
TEMPORARY VOTING MEMBERS:
Benjamin O. Anderson, M.D.
Dennis W. Boulware, M.D.
Emily F. Conant, M.D.
Nancy A. Dubler, LLB
Ruth A. Lawrence, M.D.
Stephen Li, Ph.D.
Ellice S. Lieberman, M.D.
Barbara R. Manno, Ph.D.
Mary H. McGrath, M.D., MPH
Michael J. Olding, M.D.
Celia Witten, Ph.D., M.D., FDA
C O N T E N T S
Call to Order and Introductions,
Thomas V. Whalen, M.D. 5
Open Public Comment:
Virginia Silverman 11
Dr. Marie Pletsch 13
Dr. Philip C. Haeck 16
Susan Schambeck 20
Julie Godoy (read by J.
Rosanna) 22
Holly A. Feustel 27
Dr. Elvin G. Zook 29
Ruby Rahn 32
Donna Sims (read by
Nicole Rudick) 35
Dr. Karen Becker 38
Lale Goddard (read by
Ruby Rahn) 41
Teresa Hamilton (read by
Erica Clare) 44
Cheryl Robinson 47
Linda Dintino (read by
Stephanie Donny) 50
Rebecca J. Smith-Miles 52
Myrl Jeffcoat (read by
Pam Dowd) 54
Elaine Donnelly (read by
Kathleen Witter) 57
Rogene Schorer (read by
Georgiana Hanson) 60
Wanda Simison (read by
Sibyl Goldrich) 63
Lois A. Travis (read by
Jan Erickson) 66
Deborah Guillory (read
by Jennifer Cook) 70
Gerie A. Voss 71
Susan Pope Helman 74
David Helman 78
C O N T E N T S (Continued)
PAGE
Open Public Comment: (Continued)
Dr. Christopher Batich 79
Marilyn Malnack 87
Leslie A. Rumsey 90
Nikki Dollie 92
Mike Dollie 96
Dr. Ernest Lykissa 96
Audrey Sheppard 108
Dr. Elizabeth Connell 110
Dr. T. Wade Clegg, III
(read by Erin Hemstra) 116
Lynda Roth, Coalition of
Silicone Survivors 118
Dr. Jane Zones, Breast
Cancer Action 123
Cynthia Pearson,
National Women's
Health Network 128
Mary Dickerson 133
Joe Kelly, Dads and
Daughters 134
Jama K. Russano,
Children Afflicted
with Toxic Substances 141
Rodney Hayton, National
Silicone
Implant Foundation 147
Dr. Carolyn Kerrigan,
Plastic Surgery
Educational Foundation 150
Dr. James H. Wells,
American Society of
Plastic Surgeons 158
Mary McDonough, In the
Know 169
Dr. Diana Zuckerman,
National Center for Policy
and Research for
Women and Families 172
Open Panel Discussion 183
Sponsor Summation, Scott Spear, M.D. 228
Concluding Panel Deliberations and Vote 266
P R O C E E D
I N G S
Call to Order and Introductions
DR.
WHALEN: Welcome to the second day of
the General and Plastic Surgery Devices Advisory Panel. I would like to ask the panel members to
give a brief reintroduction of themselves with their area of particular
expertise as it relates to this PMA, starting to my right with Dr. Choti.
DR.
CHOTI: Michael Choti. I am a general surgeon in surgical oncology
at Johns Hopkins Hospital, and my interest is in clinical cancer surgery.
DR.
BLUMENSTEIN: Brent Blumenstein,
biostatistician working independently.
DR.
CONANT: Emily Conant, Associate
Professor of Radiology, University of Pennsylvania. I am a breast imager, chief of breast imaging there.
DR.
LIEBERMAN: Ellice Lieberman. I am an associate professor of obstetrics
and gynecology, Harvard Medical School, and Associate Professor of Maternal and
Child Health at the Harvard School of Public Health, and my expertise is in
epidemiology.
DR.
MANNO: I am Dr. Barbara Manno, from the
Louisiana State University Medical Center, in Shreveport, Louisiana. I am a professor in the Department of
Psychiatry. My background is toxicology
and my sub-specialty within toxicology these days is forensic toxicology.
MS.
BROWN: I am Debera Brown, the Vice
President of Regulatory Affairs for Broncus Technologies. I am the industry representative for this
panel, and I have had over 20 years of experience in medical device
development.
MS.
GILBERT: I am Alisa Gilbert. I am the consumer representative. I am also a breast cancer survivor and
founder of the Unbroken Circle in the Office of Native Cancer Survivorship.
DR.
WITTEN: I am Celia Witten. I am the Division Director of the Reviewing
Division at FDA for these products.
DR.
MILLER: I am Michael Miller. I am Professor of Plastic Surgery at the
University of Texas MD Anderson Cancer Center.
DR.
ANDERSON: Ben Anderson, breast cancer
surgeon, surgical oncologist from the University of Washington in Seattle.
DR.
LI: Steve Li, President of Medical
Device Testing and Innovations in Sarasota, Florida and my areas are
biomaterials and biomechanics.
PROF.
DUBLER: Nancy Dubler. I am Director of the Division of Bioethics
at Montefiore Medical Center, and a professor of Epidemiology and Population
Health at the Albert Einstein College of Medicine.
DR.
NEWBURGER: I am Amy Newburger. I am in private practice in dermatology, in
New York. I teach at St. Luke's
Roosevelt Hospital Medical Consortium.
DR.
BOULWARE: I am Dennis Boulware,
professor of medicine, University of Alabama, at Birmingham, and a
rheumatologist.
DR.
LEITCH: I am Marilyn Leitch. I am a surgical oncologist and professor of
surgery at the University of Texas Southwestern Medical Center, in Dallas.
DR.
CHANG: Good morning. I am Phyllis Chang, plastic surgeon and an
associate professor in the Department of Surgery at the University of Iowa
College of Medicine.
DR.
KRAUSE: My name is David Krause. I am the executive secretary of this panel
and I am also in the branch that reviews these devices.
DR.
LAWRENCE: I am Ruth Lawrence,
University of Rochester School of Medicine, Department of Pediatrics and
Ob/Gyn. I am a pediatrician, clinical
toxicologist, and my special interest is newborns and breast feeding.
DR.
WHALEN: Thank you. I am Tom Whalen. I am Professor of Surgery and Pediatrics at Robert Wood Johnson
Medical School and the Acting Chair for this Panel.
There
are brief housekeeping attention details that probably need to be presented in
a little while when more people come in.
For those who did not stay until the end last night, the panel did
conclude the scheduled day's business and did get through the FDA
questions. I will very briefly go over
the results of those deliberations as we begin this afternoon's activities
before the panel has final deliberations and voting.
What
we are about this morning is further public testimony that will probably take
up the entire morning until the lunch break, which will be about midday or
perhaps slightly later. We will then
have final summation and closing by FDA and then by sponsor and then the panel
will deliberate.
To
reiterate something that I said yesterday, which apparently was not heard by
many people, please either turn off your cell phones or place them on silent
mode because it is extraordinarily rude to have them continuously going off
when we are trying to hear people who have significant messages to give us from
the podium, and the panel's deliberations as well.
We
now will proceed with today's open public comment session. All persons addressing the panel are asked
to speak clearly into the microphone as the transcriptionist is dependent upon
this means of providing an accurate record of this meeting. I would specifically now like to have the
attention of all the individuals who are registered to speak to the panel
today. You have all been given a number
corresponding to your order of appearance.
Please come to the podium area in advance so that we are not spending a
great deal of time in transitions from speaker to speaker. Specifically, we would ask that the speaker
who is next to speak be in the corridor between the chairs, towards the end of
that corridor, as the person is speaking at the podium.
I
would also like to remind you that we will have a timer to help you remain on
time. In view of the large volume of
people who are going to speak to us today, it will need to be rigorously
enforced and I apologize in advance for intrusions upon you if you extend
beyond your allotted time. At the
30-second mark there will be a yellow continuous light that comes on in front
of you, and then a red light at the conclusion of that time.
I
would finally like to address the issue of financial disclosure. Both the FDA and the public believe in a
transparent process for information gathering and decision-making. To ensure such transparency at the open
public hearing session of the advisory committee meeting, FDA believes that it
is important to understand the context of an individual's presentation.
For
this reason, FDA encourages you, the open public hearing speaker, at the
beginning of your written or oral statement to advise the committee of any
financial relationship that you may have with the sponsor, its product and, if
known, its direct competitors. For
example, this financial interest information may include the sponsor's payment
of your travel, lodging or other expenses in connection with your attendance at
the meeting. Likewise, FDA encourages
you at the beginning of your statement to advise the committee if you do not
have any such financial relationships.
If, however, you choose not to address this issue of financial
relationships at the beginning of your statement, it will not preclude you from
speaking.
We
will start with those individuals who have notified the FDA of their request to
present in the open session. Speaker
number one, please come to the podium.
Open Public Comment
MS.
SILVERMAN: Good morning. My name is Ginger Silverman. I am from California, and Inamed provided me
transportation and my accommodations for coming to the meeting.
Twenty-four
months ago I was diagnosed with ductal carcinoma in situ, breast cancer. That is the bad news. The good news is that I basically had breast
cancer for about seven days. Because of
my familiarity with the disease, all the statistics, my knowledge of the
options that were available to me and the possible outcomes, I chose the most
aggressive treatment available to me at the time. I had a double mastectomy two years ago, and that happened one
week after my radiologist's phone call.
As
a result of my early diagnosis and my aggressive proactive choices, I now have
silicone breast implants and did not need radiation or chemotherapy. The discovery of, and subsequent process of
ridding my body of breast cancer held many miracles. Finding the right doctors is probably at the top of the list;
embracing the love of my friends and family who gathered around to support me
through the ordeal; and learning a lot about myself, my courage.
Surprisingly,
my ability to heal was facilitated in an unanticipated way, my selection of
silicone breast implants. My plastic
surgeon recommended them because I chose immediate breast reconstruction and I
wanted to have the most natural look possible.
I have no uncomfortable side effects and I could not be happier with the
results. They have actually helped me
in my process of recovering my life.
I
have a five-year old daughter. Her name
is Eve, and she has just started kindergarten.
She looks at life through very impressionable eyes and I made it my
life's mission to be a healthy role model for her as I made it through the past
two years. I wanted her to see that she
had a choice in the way that she dealt with adversity, and choice is the
operative word in that. Women who
choose or need breast implants for any reason should be allowed to make an
informed decision on the type of implant they choose. Silicone breast implants are available in many other countries
outside of the United States but no woman should be forced to leave the country
in order to satisfy her choice.
Just
as I teach Eve she can choose the way that she lives her life, I am asking you
to please let American women have the choice of what implants to put into their
own bodies. They have a right to make
the recovery of their lives the best that it can possibly be. Thank you very much.
DR.
PLETSCH: Dr. Whalen, advisory panel, my
name is Dr. Marie Pletsch. I am a
board-certified plastic surgeon and have been in private practice in Santa Cruz
and Monterey, California for the last 34 years. I took care of my own expenses to come to this meeting. My only connection with Inamed is that I
have been an investigator in their core study for silicone gel breast implants,
and I have also been an investigator for some of their competitors. I am not a witness nor a party in a pending
lawsuit regrading these implants.
I
am grateful for having had silicone implants available to me when I was
diagnosed with breast cancer in 1988 and underwent bilateral mastectomies and
reconstruction. The original implants
were replaced in 1991, using McGhan, now Inamed, anatomic or shaped implants,
not because there was anything wrong with the first set of implants but because
I was undergoing a revision of my reconstruction and I requested changing of
the implants for a larger size and more anatomical shape. Please note, reoperation is not necessarily
an indication that there is something wrong with the implant.
I
may be the only presenter before this panel that can boast a unique combination
of having implanted approximately 1,000 women with silicone gel breast implants
and over 200 of these have been since the restrictions in 1992. In addition to that, I have implanted
approximately 500 women with saline implants.
Added to this, I am a female plastic surgeon with implants myself and
this gives me a more intimate view of the situation both from a patient's and a
surgeon's viewpoint.
When
asked by my patients and the press, are these implants safe? I confidently answer yes. If they were not safe, do you believe that I
would keep these implants and would not have them removed, and why would I
continue to use them? I have implanted
silicone gel breast implants since the mid-1960s and since 1992 I have used
them every time the FDA protocol allows them to be used.
What
I believe is a tragedy is the harm that has come to American women in many ways
because of these restrictions. I will
list several of them. First, many women
were falsely frightened about effects of silicone implants and many had
unnecessary surgery to remove them.
Some did not replace them with anything and were consequently deformed,
causing physical and psychological damage.
Others replaced them with saline implants, only to find out saline
wrinkled and sometimes deflated. Some
of these women then requested replacement implants with silicone again.
Secondly,
some women with various diseases have erroneously been led to believe that
their illnesses were due to breast implants when, in fact, they were due to
other causes.
Thirdly,
women who could afford it left the country to go to other countries that allow
these implants.
DR.
WHALEN: Doctor, you need to conclude,
please.
DR.
PLETSCH: American women apparently do
not have the right to choose the type of implants. The rest of the world uses these 95 percent of the time. I was in Germany in 1998 at the ECWON meeting
and they were shocked and horrified by the actions of the FDA. I ask you to look at the scientific facts
and to encourage the FDA to lift the restrictions. Thank you.
DR.
HAECK: My name is Phil Haeck. I am a board-certified plastic surgeon,
practicing in Seattle, Washington. I
have been in practice for 18 years and I am a plastic surgeon without implants.
I
am the editor of Plastic Surgery News, the monthly news magazine of the
American Society of Plastic Surgeons.
This organization has paid my travel expenses to be here today. I have no financial interest in any device
manufacture or their subsidiaries of affiliates. Breast surgery accounts for approximately 20 percent of my
practice.
I
am going to address the issue of reoperation in breast augmentation surgery
since it has not been given an adequate airing here from the standpoint of the
surgeon. Plastic surgeons dealing with
the challenges of a practice in breast surgery are not at all surprised at the
reoperation rates reported here yesterday.
So,
this is what I tell my patients who have decided to undergo a breast
augmentation procedure: You are about
to begin on a road to satisfaction. To
get there may mean more than just the one surgery, the one you and I have
planned.
There
are only two reasons for immediately going back to the operating room in the
first few days after breast surgery.
Severe bleeding is extremely rare but if it is severe and results in a
collection of blood around the implant a hematoma may occur. Most of those will need to be drained in a
short second operation.
Likewise,
an infection around the implant will need a short operation to drain the
liquids off and possibly remove the implant for a week or more. It can then safely be replaced. Both of these are extremely rare problems
that happen in less than one percent of cases.
All
other reasons for reoperation happen later, over the time period of three to
twelve months after the operation, or rarely, even years later when an implant
fails.
Capsular
contracture can and does occur. You
should expect that it could occur anywhere from three to ten percent of my
patients, but if it happens to you and you need reoperation, then it will feel
more like it is 100 percent, and it may be painful both before and after
reoperation.
After
this, the reasons relate to just two categories: My skills in correcting your preexisting asymmetry of your
breasts, or the way in which your body healed or didn't heal correctly after
the surgery.
It
is a rare patient that arrives in my office requesting breast surgery who feels
she has a perfect match between her left and right breasts. Many have quite a different appearance from
side to side. You are probably
expecting perfection and it is my intention to give that to you, but there is
always the chance that what seemed like adequate correction at the time of
surgery may not prove later to be to your or my liking.
I
tend to prefer to err on the conservative side since that is always easier to
adjust later. Complex intraoperative decisions
about the modification of the infra-mammary fold, release of the pectoral
muscle, re-positioning of a drooping nipple, and differential sizing of the
implants may not turn out in the healing phase to have been exactly what was
needed to provide a mirror image.
The
more extreme the preoperative differences from side to side, the greater the
likelihood that a second operation will be needed. Nevertheless, these secondary surgeries are not drastic
operations and frequently can be performed with local anesthesia. The patient usually returns to her normal
routine within 48 hours or less, and I do not charge the patient a professional
fee for these surgeries.
The
difficulty here, in my opinion, is that we look at any reoperation as a
statistic. But breast augmentation
surgery is a unique situation in the realm of all surgical procedures. Lumping and minor scar revision go into data
that also holds statistics for implant failures and reoperations for ruptures--
DR.
WHALEN: Doctor, you need to conclude.
DR.
HAECK: --which gives a dangerously
over-jaded look into this situation. We
are in a unique predicament here that does not have the morbidity precedent in
another area of surgery. As long as
both the surgeon and the patient expect perfection from this operation, there
will always be another patient on tomorrow's surgery schedule somewhere who is
not undergoing her first surgery. Thank
you.
MS.
SCHAMBECK: Good morning. My name is Susan Schambeck. I am the recipient of gel implants made by
Inamed Corporation. Inamed has provided
my travel and lodging expenses here.
I
would like to share my story with the panel.
I decided to have breast surgery in 1995. I feel that my decision was well thought out, and my research led
me to Dr. Pletsch, in Santa Cruz, California.
I was 36 years old and the mother of a two-year old son, Norton. I had nursed him for a little more than a
year and felt confident that giving him that kind of healthy start in life was
a gift. I felt complete with having one
child to leave my legacy to and it was time to give myself a gift. Since I have always been athletic and
outgoing, I saw an opportunity to get my body back into balance. Dr. Pletsch was very helpful in that
process. I knew that I was a good
candidate for breast augmentation. I
knew that it would be a significant boost for my self-esteem and personal image. These are the best years of my life and it
is very important to have choices.
I
had my surgery in February of 1995. My
only choices were to have saline implants or live with the effects of nursing
my son. I chose the saline
implants. The end result of that
procedure was that I had severely wrinkled implants that looked and felt
unnatural. In July of 1999 one of the
implants ruptured. After discussing my
options with Dr. Pletsch and my family, I was able to choose an upgrade to
silicone gel implants.
I
realized the difference in the look and feel of the silicone gel
immediately. It was far superior to the
saline. I am convinced that if I had
had a choice, I would have chosen the silicone gel over the saline. I didn't like the feeling of wrinkled water
bags in my body. They caused me to feel
self-conscious. With the silicone gel
implants I feel that I have a very balanced and natural shape. Nothing about the silicone gel feels
unnatural. The consistency is as close
to the real thing as it gets and I am very happy with the result.
I sincerely wish that every woman who is considering an enhancement or reconstructive surgery could some day have real choices from the beginning of her journey. I personally feel honored to assist in that process. It doesn't seem fair to me to require two surgeries in order to achieve a choice. I am very happy and healthy with the gel