Background: Breast implants have been used worldwide for more than 40 years.
Despite extensive clinical experience, there is continued concern about the
safety of these devices. The purpose of this study was to compare the efficacy,
complication rates, frequency of re-operation, and degree of patient satisfaction
with different types of implants.
Methods: This is a consecutive, population-based study consisting of all patients
receiving implants at a multidisciplinary breast center between 1979 and 2004
(25 years). A prospective implant database was constructed and maintained in
Excel, and statistical analysis was performed using SAS 8.2. Various outcomes,
including infections, hematomas, undesirable waviness, capsular contracture,
deflation, rupture, reoperation, and patient satisfaction, were monitored.
Results: Data were collected on 3495 implants in 1529 women. The longer
implants were in place, the greater the cumulative risk of developing contracture;
hematoma significantly increased the risk of contracture; smooth and
textured implants had similar contracture rates; polyurethane foam–covered
implants had a reduced risk of contracture persisting for at least 10 years after
implantation. There was a relatively high rate of reoperation and a relatively
short interval between primary surgery and reoperation; the most common
indication for reoperation was capsular contracture. Implant recipients expressed
a high overall level of satisfaction.
Conclusions: Breast implants are associated with a significant rate of local
complications and reoperation. There are marked differences in outcomes as
a function of implant surface type and surgical indication. Despite relatively
frequent complications and reoperations, implant recipients are largely
satisfied. (Plast. Reconstr. Surg. 117: 757, 2006.)
Silicone breast implants have been widely
used in the United States and throughout
the world for more than four decades. During
this time, there has been growing concern
about the safety of these devices, with regard to
both local complications and possible systemic
effects. A large body of scientific literature has
been published addressing a possible association
between silicone implants and cancer.1–6 There
is overwhelming epidemiologic evidence that
women with implants are not at increased risk
for primary or recurrent breast cancer or other
tumors. 7–11 In fact, some studies suggest a lower
rate of breast cancer in augmented women. 12–16
Similarly, there is abundant literature demonstrating
lack of an association between silicone
breast implants and immune diseases or any systemic
illness. 17–24
In contrast, recent studies have documented a
significant incidence of local complications and
side effects from breast implants. 25–45 It has also
been determined that a relatively large proportion
of implant patients require revisional
surgery. 46–51 Long-term follow-up of breast implant
recipients is difficult for several reasons.
Patients who believe they are doing well have
little incentive to return for routine reexamination.
Patients who are dissatisfied often seek
opinions (and subsequent treatment) from another
physician. Also, the population in the
United States is mobile; thus, over time, patients
frequently relocate and may be difficult to contact.
Implant registries and large-scale manda-
tory trials have only recently been established.
Even in national manufacturer-sponsored studies,
only a relatively small proportion of patients
complete the desired follow-up. 52–54 For all these
reasons, our knowledge of complication rates
and outcomes following breast implant surgery
remains imprecise. The purpose of the current
study was to investigate long-term outcomes,
complications, reoperation rates, and patient satisfaction
among breast implant recipients
treated in a single practice and followed for as
long as 25 years.
PATIENTS AND METHODS
This is a population-based study consisting of
all implant recipients operated on at a multidisciplinary
breast center and in a subsequent solo plastic surgery
practice. The population consists of a consecutive
series of women undergoing breast implant
surgery during the 25-year period between
June of 1979 and June of 2004. All patients receiving
implants for cosmetic, reconstructive, or
revisional surgery were included. Reconstructive
surgery was defined as any case where an implant
was used (with or without preceding tissue expansion)
to restore a breast disfigured by cancer treatment.
Revisional surgery included all patients
(cosmetic or reconstructive) undergoing secondary
implant procedures, regardless of the indication
for surgery. Women who were evaluated or
treated at our center for conditions related to
breast implants inserted elsewhere were excluded
because of the difficulty in obtaining reliable information
about implant procedures performed
at other facilities.
All surgical procedures were performed by
one of two board-certified plastic surgeons working
as part of an integrated, multidisciplinary
“team.” There was consistency in the care provided,
both from surgeon to surgeon and over
time (e.g., the two surgeons used similar operative
techniques, administered antibiotics uniformly,
applied similar dressings, used the same postoperative
instructions, and scheduled follow-up visits
in a consistent manner). Implant patients were
never “discharged” or told to “return prn”; all
patients were given appointments for follow-up
indefinitely over the course of this study. Patients
were not charged for follow-up visits.
A prospective breast implant database was established
in January of 1990. To incorporate data
relating to implants inserted before inception of
the database, information was obtained from
chart review of all patients who underwent implantation
between June of 1979 and December of
1989 (1122 implants in 508 women). The protocol
for chart review called for extraction of data relating
to patient demographics, details of the surgical
procedure, type of implant, early and late
postoperative complications, degree of capsular
contracture at intervals, and laboratory and mammographic
findings. As charts were reviewed, findings
were entered onto custom-designed data
sheets and subsequently transferred into a computerized
database.
The database was updated in 2003 to 2004 by
performing a comprehensive record review of all
implant recipients for whom charts were available.
Data extraction forms were created in collaboration
with the Department of Biomathematics at
the UCLA School of
Medicine. The data abstraction forms were designed
to collect demographic information, confirm
details of the surgical procedure, and monitor
postoperative complications. The database
was further enhanced with information obtained
from a comprehensive patient questionnaire. The
breast implant questionnaire, also devised in collaboration
with the UCLA Department of Biomathematics, consisted
of a 21-question instrument designed to solicit
information about patient demographics, implant-
related complications (including degree of
capsular contracture), and level of patient satisfaction.
Because many patients in this series had
multiple implants over time, the questionnaire
called only for information relating to the current
implant(s) or, in the case of explanted patients,
the most recent implant(s). The date of implantation
of the device in question was provided on
the questionnaire to avoid ambiguity. In cases of
bilateral implants, information was collected separately
for the right and left sides.
A total of 1555 questionnaires were mailed
between May of 2003 and May of 2004. The post
office returned 702 questionnaires (nondeliverable/
incorrect addresses). It is believed that 853
questionnaires were delivered to recipients. A persistent
effort was made to encourage patients to
complete and return questionnaires. This included
remailing questionnaires in all cases where
the original questionnaire was not returned by the
post office or completed by the patient, and telephone
calls to patients who failed to return questionnaires.
As a result of these measures, a total of
429 patients (50 percent) ultimately completed
and returned questionnaires.
For purposes of this study, each breast implant
was considered separately and its history tracked
from the date of insertion until the date of explantation
or the last follow-up visit. In patients
who underwent revisional surgery with insertion
of a new implant, a new record was created to track
complications and outcomes related to the new
device. In the relatively few cases where surgery
(e.g., capsulotomy) was performed and the same
implant reinserted, the prior record pertaining to
that device was terminated (censored) and a new
record was created to track the implant from the
date of reinsertion.
Patients with Baker grade 1 or 2 capsules were
defined as free of contracture, and patients with
Baker grade 3 or 4 capsules were considered to
have significant contracture. The date of onset of
contracture was defined as the date a Baker 3 or
4 capsule was first documented in the medical
record. In the case of patients who self-reported
significant contracture (by means of the breast
implant questionnaire), the date of onset was considered
to be the date the questionnaire was completed.
Contracture rates were expressed in terms
of incidence per 1000 patient-months of observation.
In addition, the incidence of contracture
over time was evaluated using the Kaplan-Meier
method of survival analysis. In applying the
Kaplan-Meier method to the study of capsular contracture,
the assumption was made that when implants
are placed bilaterally, each is independent
of the other with regard to the risk of contracture.
This is in accordance with the current prevailing
view. 55
Complications that tended to occur over a discrete
time frame in the early postoperative period
(e.g., hematoma, infection) were evaluated based
on occurrence as a function of the total number
of cases (raw rate), whereas complications that
occur over a longer time frame (e.g., implant deflation,
rupture, contracture) were calculated in
relation to the total number of patient-months of
risk.
Hematoma was diagnosed if there was significantly
greater than expected bruising, swelling,
and firmness of the breast or if surgical exploration
revealed the presence of excessive blood
around the implant. Infection was considered to
have occurred if there were symptoms of abnormal
swelling, erythema, tenderness, and fever that
either resolved with antibiotics or required explantation.
Culture and sensitivity studies were obtained
when possible to confirm suspected infections.
Untoward outcomes such as excessive
waviness or rippling were considered to have occurred
when the degree of deformity was beyond
what would normally be expected in a particular
clinical setting, required surgical revision, or was
self-reported by patients as being problematic.
Rupture of silicone gel implants was based on
clinical confirmation at the time of explantation.
The diagnosis of gel implant rupture was not made
on the basis of mammography, ultrasound, or
magnetic resonance imaging findings. The diagnosis
of saline implant deflation was made from
physical examination and was confirmed at the
time of implant replacement.
The rates of reoperation, and the indications
for revisional surgery, were determined from review
of progress notes and operative reports. Patient
satisfaction was ascertained from medical
records and from responses on the breast implant
questionnaire. Patients were given the opportunity
to rate their overall satisfaction on a five-point
scale, with 1 being least satisfied and 5 being most
satisfied.
The database was constructed and maintained
in Excel. Outcomes were compared among surgical
procedures, different surfaces, and different fillers.
For comparing the incidence of contracture over time
the Kaplan-Meier method of survival analysis (the log rank
test) was used. This methodology is ideal for studying
progressive phenomena such as contracture
because it allows for staggered entry of cases into
the trial and irregular loss to follow-up. With the
Kaplan-Meier method, only actual observations
are used to determine contracture rates; implants
are eliminated from consideration (censored) as
of the date contracture occurs or beyond the date
of the last follow-up visit. Because there are multiple
levels of procedures, surfaces, and fillers, the
overall log rank tests do not spotlight where differences
occur; thus, additional log rank tests were
performed to compare only two of the groups at
a time. These are reported after the overall tests
among the multiple groups.
For shorter term outcomes such as infection,
overall comparisons were performed using chisquare
tests for differences in percentages across
the multiple groups. For these outcomes, two of
the groups were compared by using contrast statements
in logistic regression. The p values from
these contrasts are reported after the overall chisquare
tests, showing one p value for each twogroup
comparison. For patient satisfaction, measured
on a five-point scale, nonparametric
statistics were used. For the overall model, the
Kruskal-Wallis test was used. Additional comparisons
between two groups were made using the
Wilcoxon rank sum test.
RESULTS
This study yielded information on a total of
1529 patients and 3495 implants. Occasionally, an
analyzed measure has missing data for a few implants,
which were therefore excluded from
counts as deemed appropriate. The study included
825 augmentation patients who received
1601 implants, 264 breast reconstruction patients
who received 352 implants, and 695 implant revision
patients who received a total of 1534 implants.
Follow-up ranged from 0 to 280 months
(23.3 years), with a mean follow-up (per implant)
of 37.4 months.
37.4 months.
A variety of implants were used over the course
of this study, including 1137 saline-filled devices,
778 double-lumen (gel/saline) prostheses, 1537
silicone gel-filled implants, and 38 implants with
other fillers (e.g., Trilucent, Misti Gold). With regard
to surface texture, there were 2067 smooth
implants, 848 mechanically textured prostheses,
and 568 polyurethane foam-covered devices (Table
1).
The occurrence of capsular contracture was
studied as a function of the type of procedure
performed and the surface texture of the implant.
Contracture rate (Baker grade 3 or 4 per 1000
patient-months) was 1.99 after augmentation, 5.37
after breast reconstruction, and 4.36 after implant
revision surgery. The rate of significant contracture
was 3.85 with smooth implants, 3.23 with textured
implants, and 2.19 with polyurethane foam–
covered implants. Survival analysis curves were
generated using the Kaplan-Meier methodology.
These graphs depict the likelihood of remaining
contracture-free over time as a function of type of
surgical procedure and implant surface characteristics
(Figs. 1 and 2). Reliable data were available
out to 10 years of follow-up.
Hematoma was least frequent following breast
augmentation, occurring in 24 of 1601 (1.50 percent)
implants; more frequent after implant revision
surgery, occurring in 29 of 1534 (1.89 percent)
implants; and most common in association
with breast reconstruction, occurring in 10 of 352
(2.84 percent) implants. Chi-square analysis and
pairwise tests revealed no statistically significant
difference in the incidence of hematoma as a function
of the type of surgical procedure performed.
Hematoma was also studied as a function of implant
surface texture. Hematoma occurred in 35
of 2067 (1.69 percent) smooth implants, 15 of 848
(1.77 percent) textured implants, and 13 of 568
(2.29 percent) polyurethane foam–covered implants.
Chi-square analysis and pairwise tests
showed no significant difference in the incidence
of hematoma as a function of implant surface texture.
The effect of hematoma on the risk of developing
contracture was studied by comparing the
contracture rate for implants with and without
associated hematomas. Contractures occurred in
12 of 63 implants where there was a hematoma
compared with 412 of 3432 implants without hematoma.
The contracture rate (number of Baker
grade 3 or 4 contractures per 1000 patientmonths)
was 7.17 for implants with hematoma and
3.27 for implants without hematoma. This was a
significant difference (Kaplan-Meier log rank test,
p = 0.0068). The relative risk for contracture in
the event of hematoma was 2.19.
Infection rates were determined in relation to
procedure type and were noted to occur in 19 of
1601 implants (1.2 percent) used for augmentation,
16 of 352 of implants (4.6 percent) used for
breast reconstruction, and 32 of 1534 of implants
(2.1 percent) used for secondary revisions (Table
2). When infections were categorized as a function
of implant surface texture, they were noted to
occur in 30 of 2067 smooth implants (1.5 percent),
24 of 848 textured implants (2.8 percent),
and 11 of 568 polyurethane foam–covered implants
(1.9 percent) (Table 2).
least frequently with implants used for augmentation
[91 of 1601 (5.7 percent)], more frequently
with implants used for reconstruction [27 of 352
(7.7 percent)], and most frequently when implants
were used in revision surgery [182 of 1534
(11.9 percent)] (Table 3). The risk of undesirable
waviness was also related to implant surface texture,
occurring in 143 of 2067 of smooth implants
(6.92 percent), 38 of 568 of polyurethane foam
implants (6.69 percent), and 120 of 848 of textured
implants (14.15 percent) (Table 3).
Saline implant deflations occurred in nine of
943 smooth surface implants and 13 of 192 textured implants.
When deflation rates were calculated
as a function of the number of patientmonths
at risk, the rate was 0.34 (per 1000 patientmonths)
for smooth implants and 2.07 for
textured implants (Table 4). Silicone implant ruptures
occurred in 14 of 1123 smooth implants, six
of 618 textured implants, and eight of 568 polyurethane
foam–covered implants. When calculated
in terms of risk of rupture as a function of
length of follow-up, the rate was 0.308 (ruptures
per 1000 patient-months) for smooth implants,
0.308 for textured implants, and 0.260 for polyurethane
foam implants (no statistically significant
difference) (Table 5).
Reoperation rates (for any reason) were studied
as a function of procedure type. For implants
used in breast augmentation, 248 of 1601 (15.5
percent) required subsequent revision; when used
for breast reconstruction, 125 of 352 (35.5 percent)
underwent reoperation; and when used in
revisional surgery, 336 of 1534 (21.9 percent) required
subsequent reoperation (Table 6). The
mean duration between operation and revision
surgery was determined for various procedures. It
was shortest (16.0 months) in breast reconstruction,
longer (38.9 months) following breast revision
surgery, and longest (49.1 months) after
breast augmentation (Table 7). When the mean
duration between surgery and subsequent revision
was analyzed as a function of implant surface texture,
it was approximately the same for smooth
(36.9 months) and textured (35.5 months) implants
but significantly longer for polyurethane
foam–covered implants (47.8 months) (Table 7).
The most frequent reasons for reoperation were
capsular contracture (56 percent), size change (22
percent), and implant malposition (8 percent)
(Table 8).
The overall level of patient satisfaction was
high. When gauged as a function of procedure
type, mean satisfaction (scale of 1 to 5) was somewhat
higher following augmentation (4.40) than
following breast reconstruction (4.00) or implant
revision surgery (4.02) (Table 9). There was no
statistically significant difference in self-assessed
patient satisfaction as a function of implant filler
material (saline versus gel). Smooth implants received
higher satisfaction scores than textured
(p = 0.0003) and polyurethane foam–covered devices
(p = 0.0287).
DISCUSSION
This population-based, long-term follow-up
study of implant recipients reveals significant
differences in outcome as a result of type of
procedure performed and type of implant used.
Our findings confirm the widely held belief that
capsular contracture is least frequent after
breast augmentation, more frequent after revisional
surgery, and most frequent after breast
reconstruction.26,56 –59 Curves from Kaplan-Meier
survival analyses reveal that contracture is a progressive
phenomenon, and the longer any group
of patients is followed, the greater the cumulative
risk of developing contracture. This contradicts
the widely held belief that if patients remain contracture-
free for a year or two they probably will
not develop significant contracture.60 This finding
may also have some relevance in understanding
the cause of capsular contracture. If the risk of
contracture persists for many years after implantation
(as it appears to), it seems less likely that it
is related to acute events such as bacterial contamination,
surgical technique, drains, antibiotics,
or other ancillary measures that have a short-term
impact and more likely related to some chronic
effect of implants on adjacent tissue.
Our findings further substantiate previous reports
on the superiority of polyurethane foam–
covered implants in reducing the risk of contracture
compared with smooth or textured
implants.61–63 At the end of 10 years of observation,
among patients for whom data were available, 75
percent of those with polyurethane implants remained
contracture free compared with 65 percent
with either smooth or textured implants. In
all categories considered—augmentation, revisional
surgery, and breast reconstruction—polyurethane
implants proved superior regarding reduction
of contracture. These findings confirm
earlier reports on the benefit of the polyurethane
foam in reducing the incidence of contracture
and document the long-term duration of this effect.
Polyurethane-covered devices were voluntarily
withdrawn by the manufacturer from the U.S.
market in 1992; however, approximately 110,000
foam-covered implants were inserted in the
United States before distribution was discontinued,
and they continue to be widely used in Europe
and South America.
In our study, textured implants had a slightly
lower risk of developing significant (Baker grade
3 or 4) contracture than smooth implants. The
difference, however, was not statistically significant,
and as patients were followed for a longer
periods of time, the difference became less apparent.
Although there were initial reports in the
literature that mechanical surface texturing of
breast implants reduced the incidence of
contracture,64–66 more recent studies have suggested
that there is no significant difference between
smooth and textured devices.26,67–69 Negative
effects of textured breast implants include a
greater propensity to cause visible rippling and
waviness and a higher rate of saline implant deflation.
Both of these observations have previously
been reported in the literature26,44,70,71 and are
confirmed by the current study.
It has become increasingly apparent in recent
years that breast implant recipients experience a
significant incidence of complications and a relatively
high rate of reoperation.46–51,72 In largescale
follow-up studies conducted by manufacturers,
it was reported that by the end of 5 years,
women undergoing augmentation with salinefilled
implants had a 10 percent rate of significant
(Baker grade 3 or 4) contracture, approximately
a 10 percent incidence of deflation, and even
higher rates of wrinkling and breast pain. Between
20 and 25 percent of saline-augmented patients
underwent reoperation within the first 5 years.54,72
Complications associated with silicone gel implants
were even more prevalent.31,73,74 According
to manufacturers, at the end of 3 years, women
undergoing gel implant reconstruction had a 20
percent risk of contracture (Baker grade 3 or 4),
nearly a 30 percent risk of implant removal/replacement,
and an overall reoperation rate of 45
to 50 percent.53
The findings in our implant population were
similar. We noted a high overall rate of reoperation.
The lowest rate (15.5 percent) and longest
mean duration to reoperation (49.1 months) was
among augmentation patients; the highest rate
(35.5 percent) and shortest mean duration to reoperation
(16.0 months) was among breast reconstruction
patients. The mean duration to reoperation
also varied as a function of implant surface
texture. The longest mean duration was with polyurethane
foam–covered implants (47.8 months),
and the mean duration was nearly identical with
smooth (36.9 months) and textured (35.5
months) implants. It is likely that the longer mean
duration until reoperation in cases with polyurethane
foam–covered implants is related to the
reduced tendency to develop clinically significant
contracture.
The reasons for reoperation among our patients
were similar to the reasons previously reported
by manufactures. In our series, the most
common overall indication for reoperation was
capsular contracture and the second most common
was size change. In manufacturers’ studies,
the most common reason for reoperation after
breast augmentation was size/style change and
the most common reason after breast reconstruction
was capsular contracture.
and the relatively frequent need for reoperation,
breast implant recipients are largely satisfied.
Among our patients, the highest level of satisfaction
was in augmentation patients, but other categories
reported favorable satisfaction rates as
well. This high level of patient satisfaction among
implant recipients has been observed and reported
by others.40,75,76
Limitations of This Study
By their very nature, clinical studies have inherent
limitations. Historically, it has been difficult
to obtain long-term follow-up on implant recipients.
As in all clinical trials, some of our
patients were lost to follow-up. In this particular
study, however, there were some unique advantages.
The majority of our patients were treated at
a multidisciplinary “breast center” where many of
them returned annually for screening mammography.
This provided an opportunity to evaluate
their implants. The majority of cancer patients
undergoing breast reconstruction received their
medical and surgical oncology follow-up at our
center. These patients were seen on a regular basis
and the reconstructed breast was routinely evaluated.
This unique clinical setting provided an opportunity
for long-term follow-up not encountered
in the typical clinical practice.
is always subjective to some extent. The Baker
grading system has been universally adopted for
this purpose and is widely used in the published
literature. In our study, Baker grade was ascertained
by one of two board-certified plastic surgeons;
determination of the degree of contracture
was performed in accordance with the grading
criteria specified by Baker.77 In an effort to obtain
even longer term follow-up on patients who would
not or could not return for personal examination,
patients were canvassed with an implant questionnaire.
Patients were asked to record the degree of
contracture on each side; the criteria for the Baker
grading system were clearly explained in lay terms
on the questionnaire. However, there is always the
possibility that the grade assigned by the patient
might differ from that assigned by an independent
trained examiner. It should be emphasized that
these “self-evaluations” were not a substitute for
examination by the plastic surgeon; they were
used to obtain follow-ups of longer duration and
supplement the data in the medical records. A
number of the implant questionnaires were actually
completed at the time of a follow-up visit, in
which case the Baker grade was determined by the
examining plastic surgeon and entered onto the
questionnaire by the nurse.
There have been gradual changes in the design
of implants over time. As a result, some of the
groupings of implants designated for comparison
in this study may be nonhomogenous. For example,
there were changes in the design of the filler
valve of saline implants that might have altered the
rate of deflation; likewise, there have been
changes in the characteristics of the elastomer
shell of silicone gel implants that might affect the
rupture rate. This study reports on actual clinical
experience with breast implants over an extended
period of time and reflects experience with products
that have gradually evolved. The conclusions
derived from our data are valid for the population
of implants observed over this time frame. It is
possible that our findings may not exactly predict
the behavior of breast implants currently in use or
implants that may be used in the future.
An implant questionnaire was mailed to all
patients, and we achieved a 50 percent response
rate, which is higher than the rate reported in
most survey studies. We believe this high response
rate was attributable to persistent efforts to contact
patients and encourage them to complete and
return the questionnaire. However, there is the
possibility of some inherent difference between
responders and nonresponders; for example, the
level of satisfaction might affect the likelihood of
a patient to respond. Although we believe the high
overall response rate contributes to the credibility
of our conclusions, we acknowledge the possibility
of selection bias that might impact our findings.
CONCLUSIONS
Based on long-term follow-up of a large number
of breast implant patients, we believe certain
conclusions are warranted. Implant recipients
have a significant incidence of local complications
and a relatively high rate of reoperation. Themost
common overall indication for reoperation is capsular
contracture. The incidence of symptomatic
capsular contracture does not diminish after 1 or
2 years. The longer implants are in place, the
greater the cumulative risk for developing contracture.
The occurrence of hematomas significantly
increases the risk of developing contracture.
Polyurethane foam–covered implants are associated
with a dramatically reduced rate of contracture
for at least 10 years following implantation.
Polyurethane implants do not appear to
increase the risk of other complications such as
infection or rupture. Textured implants do not
afford significant protection against contracture
and are associated with an increased risk of wrinkling
and waviness and a higher rate of saline
implant deflation.
Among all groups of implant recipients, the
overall level of satisfaction is great despite a relatively
high incidence of complications and relatively
frequent need for revisions. We were unable
to ascertain any difference in patient satisfaction
as a function of filler material; smooth implants
received a higher satisfaction score than textured
implants but were not statistically different from
polyurethane foam.
ACKNOWLEDGMENTS
The authors acknowledge the contributions of Jeffrey
Gornbein, Dr.P.H., Department of Biomathematics,
UCLA, who assisted in
design of the patient questionnaires and data extraction
forms; and Rita Engelhardt, Dr.P.H., Department of
Biomathematics, UCLA,
who assisted in analysis of data. Jamie Carter and Joy
Lindlief, O.R.T., were instrumental in collection and
tabulation of data.
Jaime Gutierrez, M.D., was a fellow at the Division
of Plastic Surgery at the UCLA Medical Center from July of 2002 to July of
2003. Dr. Gutierrez spent approximately 20 percent of
his time working with Dr. Handel in the capacity of
research assistant, and the Division of Plastic Surgery
received a grant from Polytech Silimed, a breast implant
manufacturer located in Germany, in an
amount equal to 20 percent of Dr. Gutierrez’s salary.
Tracy Cordray, M.D., was a fellow at the Division of
Plastic Surgery at UCLA
Medical Center from July of 2003 to July of 2004. Dr.
Cordray spent approximately 20 percent of her time working
with Dr.Handel in the capacity of research assistant,
and the Division of Plastic Surgery received a grant from
Polytech Silimed in an amount equal to 20 percent of Dr.
Cordray’s salary. The implant questionnaire and data
extraction forms used in this study were developed in
conjunction with the Department of Biomathematics at
UCLA Medical Center
(David Geffen School of Medicine). In addition, the
statistical analysis of data was performed by the UCLA Department of Biomathematics.
Polytech Silimed paid the costs for these
services. The expenses incurred by Dr. Handel in producing
and mailing patient questionnaires (photocopying,
postage, secretarial) were reimbursed by Polytech
Silimed.
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