ilena

http://www.publiccitizen.org/publications/release.cfm?ID=7285

(go to the webpage for charts)

Statement by Sidney Wolfe, M.D. at FDA Hearing on Silicone Gel Breast
Implants (HRG Publication #1678)

Statement by Sidney M. Wolfe, MD
Director, Public Citizen's Health Research Group

FDA Hearing on Silicone Gel Breast Implants

October 14, 2003

Both the FDA approval standard for medical devices, "reasonable
assurance of safety", and the validity of informed consent/informed
choice are legitimate only if studies are long enough in duration and
comprehensive enough to answer existing questions about safety.
Instead of reasonable assurance of safety, there is more accurately
"reasonable assurance of ignorance" and therefore reasonable concern
about safety. If the decision is to approve now, women will not get
the information they need for truly informed consent before deciding
whether to undergo silicone gel breast implant surgery.

It is ironic that the clear evidence of certain dangers such as local
and regional complications, often from rupture, and remaining
questions about other risks that led to the 11.5 year-old moratorium
on silicone gel breast implantation (excluding post-mastectomy) were
based on much longer exposures than now exist for the implants being
seriously considered for approval today.

Despite these deficiencies in the duration of data being considered by
the FDA, (only the first three years of a planned 10-year study) there
are many red-flag warning signals within the thousands of pages of
do***ents put up on the internet last week, more than enough to
justify a decision to wait at least five more years to collect more
information on the thousands of women who already have had implants,
rather than precipitously approving these unsafe devices for marketing
to hundreds of thousands of women a year who will, once they are told
by the government the devices have "reasonable assurance of safety",
opt for the surgery to insert them and thereby participate in a
massive experiment.

The chart below shows that the complication rates of the three year
data in the 1990 Inamed study and the current "Core" study are quite
similar, examining only the data on those implants in the 1990 study
for which Inamed is now seeking approval.

The chart below compares the data from three years with that of five
years in the 1990 study and shows the striking increases in the risk
of various complications occurring between years three and five. For
example, the risk of removal/replacement increased from 6.3% to 11.5%
in just two years. Similarly, the increases in capsular contracture
were from 9.5 to 14.9%. The ***ulative risk of breast pain, not
provided at three years in these data was 25.8% and loss of nipple
sensation was 17.2% at five years. Since the five-year follow-up in
the 1990 study was not as great as it could have been, it is not
unreasonable to hypothesize that in the current core study, when the
five-year data are collected, the risks will be as high or even higher
than those found in the 1990 study.

addition to the primary deficiency of only having three years of data
in the ten- year core study, according to the FDA "In the
reconstruction study, only 59% of patients have reached the 3-year
follow-up visit.[1] Worse, the follow-up in the adjunct reconstruction
group was only 53.8% at one year and 27% at three years.[2]

Other problems noted by FDA reviewers were that in addition to 92
protocol violations in the core study, many involving a lack of
informed consent, the adjunct study had even more egregious violations
including 211 patients in whom informed consent was not obtained
before surgery, 86 patients implanted at a facility without ethical
review board approval and 25 patients implanted by a non-authorized
investigator.[3]

According to the FDA medical officer reviewing the Inamed application,
"Given these limitations in the ascertainment of asymptomatic rupture
[most patients did not have an MRI], there is concern regarding the
determination of both asymptomatic ruptures and the total rupture
rate."[4] This concern is greatly heightened by the findings of
other FDA scientists, who studied the use of MRI in the U.S. on 344
randomly chosen women (average age 51) who had had silcone gel breast
implants. Sixty eight percent of the women had at least one ruptured
breast implant, median age of implant at rupture was 10.8 years, and
21% had silicone gel outside of the fibrous capsule in at least one
breast.[5]

Despite the concern about implant rupture and spread of silicone
around the body, FDA stated that "Inamed provided no discussion of
the significance of implant rupture…..Cases of distant migration of
gel to breast, axillary lymph nodes, abdomen, groin…have been
reported…[in the published literature]." [6]

Although the 1999 Institute of Medicine Study review on breast
implants focused mainly on questions of systemic disease—and there is
considerable new information since the conclusion of that review---it
did conclude that local and regional complications were the main
safety issues and that they had not been well studied. Like the FDA
then, they further concluded that information on these complications
is crucial for women deciding whether or not they want silicone gel
breast implant surgery.

In a review of 35 different studies that encompass more than 8000
explanted silicone gel breast implants, failure was found to be 30% at
5 years, 50% at 10 years, and 70% at 17 years. The only studies that
were used were ones that reported implant duration, the total number
of silicone gel breast implants explanted, and the number of silicone
implants for which shell rupture or failure ("not intact") was
confirmed upon surgical removal.[7]

This year marks Sybil Goldrich's 20th anniversary since her battle
with breast cancer. But that was only the beginning of her fight on
behalf of women. After undergoing a bilateral mastectomy in 1983,
Sybil received silicone gel breast implants. Within 2 years, she
underwent 7 operations, 2 mastectomies, for a total of 4 sets of
implants. During this time she experienced excessive pain, capsular
contracture, migration of gel to her uterus, ovary and liver,
extrusion, necrosis and rupture. Finally, she chose to have a tram
flap procedure. In 1998, Sybil co-founded Command Trust Network, a
national clearinghouse dedicated to providing thorough and unbiased
information about breast implants. Since then, she has worked
tirelessly to ensure government and corporate accountability with
regard to breast implants. Her goal is to ensure a safe implant is
available to all women. She does not think that the short-term data
submitted for FDA approval begins to approach such a goal.

A final irony can be found in the section entitled "Preclinical-Shelf
life in one of the FDA do***ents. The do***ent states:

"Based on all shelf life data provided, Inamed supported a 2.5-year
expiration date on their package label." (tests included gel cohesion,
shell ultimate break force, shell tensile set and shell
elongation).[8] Even though many women are led to believe that these
implants will last at least ten years if not a lifetime, this 2.5
years "expiration date" is a further insult.

The apparent unwillingness of the FDA to require silicone breast
implant manufacturers to provide longer-term data as a prerequisite to
approval of such devices raises serious questions about whether the
agency is enforcing the 1976 Medical Device law to protect patients.
The major precipitating event leading to passage of that law was the
disaster concerning the Dalkon Shield intrauterine device (IUD).
Seven**** women died and thousands of women were rendered sterile
because of the increased uterine infections caused by this device.
Requiring adequate pre-approval testing for permanently implantable
devices such as breast implants was a major principle underlying the
passage of the 1976 law but the agency appears poised to negate this
principle as they consider the approval of silicone gel breast
implants

--------------------------------------------------------------------------------

[1] FDA Summary Panel Memorandum, Sept. 12, 2003, page 33.

[2] FDA Clinical Summary Memorandum, Sahar MK. Dawisha, MD., page 64.

[3] FDA Clinical Summary Memorandum, Sahar MK. Dawisha, MD., pages
9-10

[4] FDA Clinical Summary Memorandum, Sahar MK. Dawisha, MD., page 75.

[5] Brown SL et al. Prevalence of rupture of silicone gel breast
implants revealed on MR imaging in a population of women in
Birmingham, Alabama. Am J Roentgenol. 2000;175:1057-64.

[6] FDA Summary Panel Memorandum, Sept. 12, 2003, page 37.

[7] Marotta et al. Silicone gel breast implant failure and frequency
of additional surgeries: ****ysis of 35 studies reporting examination
of more than 8,000 explants. J Biomed Mater Res. 1999;48(3):354-64.

[8] FDA Summary Panel Memorandum, Sept. 12, 2003, page 29.

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