|
|
|
||||||||
The following is the result of the random sampling of 2,994 claims submitted to the MDL 926, Breast Implant Implant Global Class Action, as of June 1, 1995. This random sampling was assumed by the court to be representative of the total claims submitted, and it was these numbers which collapsed the class action suit. According to the court, "Although many anticipated some "ratcheting" (or reduction in grid amounts shown in the settlement notice), few expected the number of approved claims to be as high as these statistical estimates indicate."
In other words, the manufacturers did not expect there to be so many of us with valid claims. As we have said for years, "WE ARE THE EVIDENCE" and no number of Dow-funded epidemiological studies can change that. No one has studied us, our bodies, our flesh and blood and bones, to find out what happened and why.
Read below, and find out what the manufacturers of silicone (gel or saline filled) breast implants don't want you to know.
(There are 2 tables which are not yet included in this page, disease and severity by rupture, and disease and severity by legal representation.)
DISEASE OCCURENCE IN SILICONE BREAST IMPLANTED WOMEN:
ESTIMATES FROM THE SAMPLE OF DOMESTIC CLAIMANTS
Shanna H. Swan Ph.D.
Berkeley, CA
October 1, 1995
(Note: *text* indicates italics)
*Background:*
1. The court estimates that a total of 248,500 claims filed by domestic
registrants for the Silicone Breast Implant (SBI) global settlement were
postmarked by September 16, 1994.
2. This total includes 191,400 claims (77.2%) received on or before
September 16, 1994, and 57,100 claims postmarked by that date.
3. A random sample of 2,994 was drawn by the court from the first
191,400 claims.
4. The court assumed that the sample of 2,994 is representative of
all 248,500 claims, although acknowledging that there may be differences.
5. This sample includes 1,164 medical claims (38.9%) and 1,830
potential future claims. (See Figure 1).
6. The disease and severity level in the sample of 1,164 medical
claims have been reviewed by a team of trained nurses. For each claim
an "Action" was taken and each claim categorized as "Approved",
"Minor Deficiency", "Major Deficiency", or "Unknown" (Deficiency;
Major or Minor).
*Table 1 summarizes the action (here called "Approval status") by
disease and severity claimed.*
7. Of the 1,164 medical claims in the sample, 239 (20.5%) were
categorized as "Approved". In some instances a claim was approved
at a disease and severity other than what was claimed. These
approved codes are called DIS (disease approved) and SEV
(severity approved). The distribution of these variables
(approval level, DIS, SEV) in the sample are assumed to be
representative of the distribution in the total of medical claimants.
Over 90% of approved claims were approved for the disease which
had been claimed. Appendix 1 includes the disease abbreviations used.
*Table 2 compares claimed and approved diseases and severity.*
8. The distribution of diseases claimed varied little by approval
status. For example, ANDS represents 10% of Approved claims, 9.2%
of Approved plus Minor Deficiency claims and 9.7% of all medical claims.
*Table 3A contains the distribution of diseases for all medical
claims and Table 3B for Approved or Minor Deficiency claims.*
9. The distribution of disease and severity were examined for
approved claims by whether or not a rupture had been reported.
The majority of women did not know whether their implant had
ruptured (or left this blank). Overall, 29% of women reported
a rupture. However, this proportion was greater among women
with Approved Severity A (43%). Thus, rupture rate was related
to disease severity.
*Table 4 contains the Approved Disease and Severity by rupture.*
10. The proportion of claims for which claimants had
legal representation was examined by disease and severity for
all claimants. Overall, 85% of all medical claims were
legally represented. This proportion did not vary appreciably
by severity. For example, 89% of Claimed Severity A were
legally represented.
*The relationship between legal representation, Claimed Disease
and Severity are shown in Table 5.*
*Systemic Sclerosis*
1. There are four approved cases of Systemic Sclerosis (SS)
and one SS case with a minor deficiency. It has been represented
that minor deficiencies should be considered as probably valid,
because such deficiencies are largely procedural or otherwise of
minor significance. Therefore, we assume five cases of SS in the
sample.
2. The portion of the sample with major or unknown deficiencies
includes seven additional cases of SS. It is likely that at least
a fraction of these will be approved as SS once deficiencies are
eliminated. However, these cases will not be used in estimating
the total number of SS cases in the population in this analysis.
Therefore, the five cases used for estimation are likely to provide
an underestimate.
3. Since these seven uncertain cases are being eliminated from
analysis, it is necessary to eliminate all such uncertain
(Major deficiency and unknown) claims from the sample. Therefore,
the analysis which follows is based on a sample of 2,679 claims
approved or with minor deficiencies (called "valid claims" in what
follows. The remained are referred to as "outcome unknown")
4. To estimate the number of SS cases in the total population
of claims:
a) I calculated the observed proportion of SS cases in the sample
of valid claims:
*p = Proportion of valid claims with SS = 5 /2,679 = 0.19%*
b) I subtracted the projected number of claims with unknown outcome
to from the number of total to get the projected number of valid
claims in the population (N):
*N = Projected number of valid claims = 248,500 - (25,398+746) = 222,356*
c) The standard deviation of the proportion p is calculated as follows:
*SD = [(p x (1-p))/N] 1/2 =0.0008*
Therefore the estimate p +/- SD is given by 0.19% +/-0.08%.
d) I then multiplied p x N to get the expected number of cases of
SS among all claims (with known outcome):
*Total SS = N x p = 0.19% x 222,356 = 415*
Note that this estimate can also be derived by multiplying the
observed number of SS cases (5) by the ration of valid claims in
the sample to valid claims in the population:
*Total SS = 5 x (70,467/849) = 415*
5. This number (415) is likely to represent an underestimate of
the total SS cases in all implanted women for the following reasons:
a) Many cases of SS have "opted out" of the settlement and chosen
to pursue litigation. A review of two attorneys' offices identified
23 cases with medically confirmed SS who have opted out. Although
the total number of such "opt outs" is unknown, it is likely to
appreciably increase the estimate of the total number of scleroderma
cases among implanted women.
b) There are likely to be some cases which will be approved among
the 7 claims with Major Deficiencies. If only three of these were
approved, this would project to an additional 250 cases in the total
population of claims.
c) There will undoubtedly be some cases of SS who have died, as
this is a disease with limited survival. These are unlikely to
be included in the claims filed.
d) Some cases of SS may have chosen not to pursue either the
global settlement or litigation. These will not be represented
among the claims or the estimate of "opt-outs".
e) These estimates of total cases in implanted women reflect
cases diagnosed before September 1994. I have estimated that
close to 2/3 of implanted women had their implants for more
than ten years. If average letency for scleroderma is long,
which case reports and occupational data suggest, the number of
cases identified by 1994 will greatly underestimate future cases.
*Expected number of cases of SS among implanted women*
1. I have determined the distribution of implanted women by age
and year of implant in the Medical Implant Survey conducted by
the National Center for Health Statistics (NCHS). The results of
this survey were published by Bright et al. 1992.
2. I assume that NCHS estimate of 304,000 women implanted in 1988
represents an underestimate of the number of implanted women.
I have assumed that this figure underestimates the true prevalence
by 40%, and have assumed 500,000 women implanted as of 1988.
3. I have used several extrapolation models to estimate the total
prevalence of SBI through the end of 1992. Under all these models
the 1992 prevalence estimates are approximately double the 1988
prevalence. Therefore, I have assumed 1 million women implanted
with silicone breast implants. Actually, this figure is an
over-estimate since the moratorium occurred early in 1992.
4. Using the proportion of implants in each age and calendar year
from the NCHS data ( and assuming the age distribution for implants
1988-92 was the same as the average for 1985-88) I have calculated
the number of women-years in each five year age category lived by
women with SBI.
5. Assuming one million white women with silicone breast implants
and using the age-specific distribution of incidence of SS in women
(Silman AJ, 1991), I have estimated that about 75 new cases of SS
should have been diagnosed in implanted women under the null
hypothesis of no increased risk for implanted women. While
such an estimate is uncertain, it appears higher than that projected
by Sanchez-Guerrero (1994), who stated that a finding of 38 cases of
SS in implanted women "would indicate a possible association", and
thus, presumably would be above the expected number.
*If we assume 75 cases expected in implanted women a total of 415
cases in all implanted women represents a relative risk of SS of 5.5
(If we assumed a lower background rate corresponding to only 38 cases
expected, the relative risk would be 10.9.)*
*If we add the estimated 250 cases projected assuming 3 out of the
7 with major deficiencies are true SS, this increases the relative
risk of SS to 8.9.*
*If we add the 23 SS cases known to have opted out (among two
attorneys queried), this would increase the total number of SS
cases to 688 and the relative risk to 9.2.*
*Systemic Lupus Erythematosus (Lupus)*
1. The sample contained 27 approved and 17 claims with minor
deficiencies, for a total of 44 claims. This extrapolates to
a total of 3,652 cases in the total population.
2. If we assume that the incidence of Lupus in females is
approximately twice that of SS, by the above reasoning, we would
expect (under the hypothesis of no increased risk from silicone
breast implants) approximately 150 cases of Lupus in this population.
(Assuming an incidence of Lupus which is four times that of SS yields
an estimate of 300 cases)
3. Therefore, depending on what baseline incidence is assumed,
the projected number of cases of Lupus represents *a relative
risk of between 12.2 and 24.3.*
4. Using the same arguments as above, the number of Lupus cases
in the sample is likely to represent an underestimate of the total
number in all implanted women.
Appendix I
Disease abbreviations
ACTD Atypical Connective Tissue Disease
ANDS Atypical Neurological Disease Syndrome
DM Dermato-myositis
PM Poly-myositis
LUPUS (or SLE) Systemic Lupus Erythematosus
MCTD Mixed Connective Tissue Disease
PSS Primary Sjogren's Syndrome
SS Systemic Sclerosis
MULTI More than one disease claimed
BREAKDOWN OF DOMESTIC IMPLANT CLAIMS
Sample/Projected for All Claims
Total
2,994/ 48,500
Medical
1,164/96,611
Future
1,830/151,889
Approved
239/19,837
"Valid"
849/70,467
Deficient
925/76,774
Minor
610/50,630
Major
306/25,397
Unknown
9/747
10/02/95 Table 1
Approval Status by Disease Claimed
Disease: ACTD
Severity APP MIN MJR UNK
A 26 49 8 0
AB 1 0 0 0
B 78 224 50 3
BC 1 0 0 0
C 57 221 106 2
D 1 0 2 0
Totals 166 494 166 5 Total Actions: 831
% of Total: 20.0 59.4 20.0 .6
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Disease: ANDS
Severity APP MIN MJR UNK
A 13 14 6 2
B 9 33 14 0
BC 1 0 1 0
C 1 7 10 2
Totals: 24 54 31 4 Total Actions: 113
% of Total: 21.2 47.8 27.4 3.5
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Disease: DM
Severity APP MIN MJR UNK
A 1 0 0 0
C 1 0 0 0
Totals: 2 0 0 0 Total Actions: 2
% of Total: 100.0 0.0 0.0 0.0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Disease: LUPUS
Severity APP MIN MJR UNK
A 8 5 4 0
ABCD 0 0 1 0
B 3 3 9 0
C 16 9 18 0
D 0 0 4 0
Totals: 27 17 36 0 Total Actions: 80
% of Total: 33.8 21.3 45.0 0.0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Disease: MCTD
Severity APP MIN MJR UNK
A 0 2 1 0
B 1 2 3 0
C 0 0 4 0
D 0 0 1 0
Totals: 1 4 9 0 Total Actions: 14
% of Total: 7.1 28.6 64.3 0.0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Disease: MULTI
Severity APP MIN MJR UNK
A 8 5 0 0
AB 1 0 0 0
ABC 0 0 2 0
ABCD 0 0 1 0
ABD 0 0 1 0
ACD 0 0 1 0
B 6 15 19 0
BC 0 1 1 0
BD 0 2 0 0
C 2 10 12 0
CD 1 0 0 0
D 0 0 4 0
Totals: 14 36 46 0 Total Actions: 96
% of Total: 14.6 37.5 47.9 0.0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Disease: PM
Severity APP MIN MJR UNK
A 0 1 0 0
B 0 0 1 0
C 0 1 3 0
Totals: 0 2 4 0 Total Actions: 6
% of Total: 0.0 33.3 66.7 0.0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Disease: PSS
Severity APP MIN MJR UNK
A 0 1 2 0
B 0 1 3 0
C 0 0 2 0
Totals 0 2 7 0 Total Actions: 9
% of Total: 0.0 22.2 77.8 0.0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Disease: SLE
Severity APP MIN MJR UNK
A 1 0 0 0
Totals: 1 0 0 0 Total Actions:1
% of Total: 100.0 0.0 0.0 0.0
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Disease: SS
Severity APP MIN MJR UNK
A 2 0 2 0
B 2 0 1 0
C 0 1 1 0
D 0 0 3 0
Totals: 4 1 7 0
% of Total: 33.3 8.3 58.3 0.0 Total Actions: 12
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
10/02/95
Table 2
Approved Versus Claimed Disease
APPROVED
CLAIMED ACTD ANDS DM LUPUS MCTD SS Totals
ACTD 166 0 0 0 0 0 166
ANDS 5 19 0 0 0 0 24
DM 0 0 2 0 0 0 2
LUPUS 2 0 0 25 0 0 27
MCTD 0 0 0 0 1 0 1
MULTI 8 2 0 4 0 0 14
SLE 0 0 0 0 0 1 1
SS 1 0 0 0 0 3 4
-------- ----- ---- --- --- --- --- ---
Totals: 8 182 21 2 29 1 4 239
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
10/02/95
Table 3A
Distribution of Disease Claimed
Disease Number % of Total
ACTD 831 71.4
ANDS 113 9.7
DM 2 .2
LUPUS 80 6.9
MCTD 14 1.2
MULTI 96 8.2
PM 6 .5
PSS 9 .8
SLE 1 .1
SS 12 1.0
Total Claims: 1164
10/02/95
Table 3b
Distribution of Disease Claimed for All Claims Approved or
with Minor Discrepancies
Disease Number % of Total
ACTD 660 77.7
ANDS 78 9.2
DM 2 .2
LUPUS 44 5.2
MCTD 5 .6
MULTI 50 5.9
PM 2 .2
PSS 2 .2
SLE 1 .1
SS 5 .6
Total Claims: 849
Email: SOSaline@aol.com
http://members.aol.com/sosaline/Evidence.html