A Long-Term Study of Outcomes, Complications, and Patient Satisfaction with Breast Implants

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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,<