New implant study reheats old dispute
Finding indicates slightly higher risk of rare diseases
The largest study of silicone breast implants has found the devices are generally safe but associated with a slightly higher risk of a few rare diseases, a controversial finding that quickly reheated the seemingly settled issue.
The conclusion by MD Anderson Cancer Center researchers, based on the outcomes of nearly 100,000 patients who received one of the devices since they returned to the market in 2006, was disputed Friday by many experts, including federal health regulators, who have nevertheless scheduled a public meeting of medical advisers next year to consider implant safety.
“These findings aren’t meant to suggest implants caused these problems,”
said Dr. Mark Clemens, an MD Anderson professor of plastic surgery and the senior investigator of the study. “They’re associations, which underscore the need for more research in this area, but do provide key safety information for women and their providers to consider when thinking about cosmetic or reconstructive surgery with breast implants.”
‘Silicone City’
In a paper the Annals of Surgery will post online Monday, Clemens’ team is reporting that four health problems — the skin cancer melanoma and autoimmune disorders rheumatoid arthritis, scleroderma and Sjögren’s syndrome — occurred more often in patients with silicone-gel implants than in the general population. The numbers were small but statistically significant, Clemens said.
The Food and Drug Administration issued a statement in response Friday, urging “the public and health-care community to view the study’s conclusions with caution.” The statement noted concerns about “significant shortcomings” with the study’s methodology and data presentation and said “we respectfully disagree” with the conclusions.
A number of other experts in the field echoed the FDA’s concerns.
The strong reaction to the study was reminiscent of the ruckus breast implant safety concerns caused in the 1990s and first half of the 2000s. Allegations that ruptured or leaking devices caused a variety of systemic autoimmune disorders in women led to huge payouts from high-profile class-action lawsuits. Dow Corning, the leading supplier at the time, declared bankruptcy because of all the claims against it.
The issue was particularly big news in Houston, birthplace of the breast implant and site of some of the biggest plaintiff victories, many secured by the late John O’Quinn, the famed Houston trial lawyer. Texas Monthly magazine once dubbed Houston as “Silicone City.”
The FDA declared a moratorium on silicone-based implants in 1992, then lifted it in 2005 after concluding there was not sufficient evidence to tie implants to systemic autoimmune disorders. In 2006, it approved devices from Allergan and Mentor Corp. but required the companies to conduct studies on patient outcomes.
It was data from those studies, made public last year, that the MD Anderson team analyzed.
Undue alarm?
Faced with criticism, Clemens said the team “stands behind the data and feels this is the best data we have to date.” He emphasized the findings were consistent with previous implant safety studies and added that the study found 90 percent of patients were satisfied or very satisfied with their decision to get the device.
Clemens said he was heartened that his team and the FDA see a similar path going forward — not just the planned 2019 public meeting, but also the establishment of a national breast implant registry and a call for more research.
“The study is reassuring in many ways, but I fear the parts associating implants with rare diseases could unduly alarm women,” said Dr. Andrea Pusic, chair of plastic surgery at Brigham and Women’s Hospital in Boston and president-elect of the American Society of Plastic Surgeons. “They needed to be interpreted carefully.”
The study drew criticism for what experts said were fundamental flaws in the data used for the research. That included inconsistent sources of outcomes — one manufacturer required a doctor’s diagnosis of a complication; the other took the patient’s judgment at face value. As a result, disease risk rates could differ dramatically, even though the gels used by the companies are similar.
Also, more than half the women dropped out of the study by the second year, which Pusic said often happens when patients feel healthy. Their lack of updated outcomes likely skewed results, she said.
Critical commentary
In the paper, the MD Anderson team acknowledged those limitations in the data.
Annals of Surgery is a monthly journal of surgical science that has existed since 1885. The journal has posted an FDA editorial about the study as well as a highly critical commentary co-written by plastic surgeons at Massachusetts General Hospital and Memorial Sloan Kettering Cancer Center in New York. One of the two surgeons is a consultant to Allergan.
David Bernstein, a George Mason University law professor and silicone historian, said he doesn’t think the study would result in new litigation because some of the data “defies explanation,” such as an association noted between implants and a lesser risk for fibromyalgia. He said a lawyer defending a manufacturer being sued for a slight increase in rheumatoid arthritis associated with implants could easily undermine such arguments by pointing to the device’s possible protective benefit for fibromyalgia in the study.
About 400,000 women get implants annually, most silicone. The vast majority — about 85 percent — are for cosmetic reasons, the rest for reconstruction after cancer surgery.