Breast implants may be imperfect, but that hasn't stopped women from seeking perfect breasts: In North America, there were an estimated 400,000 breast implant surgeries in 2010 - some post-mastectomy and others to enhance or enlarge what was already there.
Given that a recent report by the U.S. Food and Drug Administration revealed that 20 to 40% of patients who get silicone implants for cosmetic reasons will need another surgery within ten years, you'd think that implants' days would be numbered. But it's more likely that the FDA report will only add to the decades-old debate over their safety.
It was in 1962 that silicone breast implants were first introduced (saline, a few years later). Since then, says Toronto plastic surgeon Dr. Martin Jugenburg, implants have gone through several "generations" and today have shells made of thick silicone to minimize the bleed of silicone particles out of their shell.
Concerns by several groups about leakage and a possible link to immune-system diseases led to silicone implants being pulled off the market in the U.S. in the early '90s. Around the same time, Health Canada asked for a voluntary removal of the implants from the market, though they continued to be available if requested by surgeons.
Though the FDA's most recent analysis found no link between implants and breast cancer, connective tissue disease or reproductive issues, the report raised concerns about how breast implants fared long-term. "The report states that breast augmentation is not a one-time procedure and that some women may need additional surgeries in their lifetime," Dr. Jugenburg explains. "But this is not news."
Implants are removed for various reasons, including malposition, replacement and damage during surgery. Still, these are man-made products and as such are not perfect, he says. "They can leak or rupture, and if that happens they will need to be replaced."
In the FDA report, complications included implant rupture, wrinkling symmetry, pain and infection. But the biggest reason for implant removal was something called capsular contracture or the hardening or tightening of the scar tissue around the implant.
While 20 to 36% of patients who get implants for cosmetic reasons will need what Dr. Jugenburg calls a "reoperation," the percentage is much higher (between 38 and 72%) for breast reconstructions. "We know this and specifically in breast reconstruction, we tell patients that breast reconstruction is like getting a maintenance plan. They will need at least one or more surgeries down the line."
The limited lifespan of breast implants is but one of the issues tackled by Adella Matthew, the founding president of British Columbia's Implant Awareness Society, whose members believe that all silicone implants are toxic to the body. Their website, www.implantawareness.com, lists side effects of silicone implants as everything from coughs to insomnia, and their medical experts link implants to diseases that include MS, rheumatoid arthritis, fibromyalgia and cancer.
In the FDA report, a small but unexplained link was found between implants and anaplastic large-cell lymphoma, a rare form of cancer that affects 3,000 annually in the U.S. In the past 15 years, the cancer was reported in only 34 of the five to ten million breast implant patients worldwide, says Dr. Jugenburg who adds that breast implants are the most extensively studied devices of any medical product on the market.
Nonetheless, implants require surgery and women who choose to go under the knife must consider general surgical risks such as bleeding, infection, or wound healing issues. During recovery there is swelling, discomfort, possibly numbness, changes in sensation, or implant hardening in and around the breast. Even women satisfied with their implants may still question their safety. As if all that weren't enough, now they must also consider that they may have to face additional surgeries.
On warranty?
"We always knew that implants were not lifetime devices, that sometimes they would fail," says Dr. Martin Jugenburg. "Implants come with a lifetime warranty but we can't say that it's a lifetime because they have only been on the market for 20 years. However, if there is any defect, specifically a leak or rupture, not a surgical complication, the manufacturer will replace it at no cost."
The perfect implant
The perfect implant would have no risk of capsular contracture, says Dr. Jugenburg. "It would not leak or break. It would not have rippling and would have very smooth edges so it's not visible." (Silicone implants ripple less than saline and are softer. Saline implants are often overfilled by surgeons in order to protect against rippling; as a result, they're harder.) The exterior shell of silicone and saline implants are both made of silicone.
Do your homework
Canadian Society for Aesthetic Plastic Surgery (www.csaps.ca)
Plastica Toronto Cosmetic Surgery Clinic, (www.plastica.ca)
Health Canada (www.hc-sc.gc.ca)
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