Millions of women have breast implants. First marketed in 1962, they have been regulated
by the FDA since 1976 for breast
augmentation, reconstruction after breast cancer surgery or trauma, and to
correct developmental defects or correct or improve the result of a previous
surgery. Yet, their history has been marked
by uncertainties, local complications, claims of systemic health problems and,
most recently, cancer. In 2011, the FDA identified an association between breast
implants and the development of anaplastic large cell lymphoma (ALCL) in the
fluid or scar tissue surrounding the implant. At least 457 women in the U.S. have been diagnosed with breast
implant-associated ALCL, with almost 700 cases reported worldwide. Sixteen
women have died, nine in the U.S. To
address growing concerns, the FDA has recently held new hearings to discuss breast implant safety.
Two types of breast implants are
sold in the United States: saline-filled and silicone gel-filled. Both have a
silicone outer shell that can be smooth or textured. For decades, implants have been blamed by some recipients for a number of health
problems including autoimmune/connective tissue diseases, debilitating joint pain,
fatigue, myalgias, muscle
weakness, sleep disturbances, cognitive impairment, memory loss, and dry mouth –
so-called “breast implant illness” (BII).
Back in 1992,
the FDA placed a ban on the use of silicone breast implants outside of
FDA-approved research studies. But after
two New England Journal publications in the mid-1990s failed to find an
association between implants and connective tissue disorders, and a 400 page
report from the Institute of Medicine in 1999 concluded that “although silicone
gel breast implants were potentially responsible for such local complications
as hardening or scarring of breast tissue, implants did not cause autoimmune
disease,” the ban was subsequently lifted in 2006.
Although studies
have failed to provide definitive evidence that silicone breast implants are
associated with the development autoimmune or connective tissue disease, some
argue that the studies have been inadequate – that they need to be larger and conducted
over a longer period of time. There is
evidence that the materials in medical implants are capable of producing an immune
inflammatory response and may be influenced patient genetics, comorbidities, and
lifestyle as well as anatomic location and implant duration.
It’s
important to note that breast implants do
not last a lifetime and that additional surgeries will likely be necessary. Local complications include capsular
contracture, implant rupture, breast pain, wrinkling,
asymmetry, scarring and infection. Although
most patients with ALCL can be treated with breast implant removal alone, some have
required radiation therapy, chemotherapy or both.
Despite the controversy and potential
health risks, many women experience improved mental and physical health and
quality-of-life following breast implant surgery and most report long-term
satisfaction. It will be important to
see what the FDA’s most recent hearings reveal and what the future holds. At the very least, larger, longer and better-quality
studies need to be conducted so that women and their physicians better
understand the risks and benefits of this procedure and make a more informed decision.
Judith Wolf,
MD
Associate
Director, WHEP
