The largest ever study of silicone breast implants has shown that the devices are generally safe, but are associated with a slightly higher risk of a few rare diseases, a controversial finding that quickly warmed up the seemingly resolved issue.
The conclusion of MD Anderson Cancer Center researchers, based on the outcomes of nearly 100,000 patients who received one of the devices since they came back on the market in 2006, was challenged Friday by many experts, including federal health regulators, who nevertheless conducted a public inquiry have planned. meeting of medical advisers next year to consider implant safety.
"These findings are not meant to suggest that implants caused these problems," Dr. Mark Clemens, an MD Anderson professor of plastic surgery and the senior researcher of the study. "These are associations that underline that more research is needed in this area, but that provide important safety information for women and their suppliers to think about cosmetic or reconstructive surgery with breast implants."
In a paper that the Annals of Surgery will post online Monday, Clemens & # 39; s team reports that four health problems – the skin cancer melanoma and autoimmune diseases rheumatoid arthritis, scleroderma and Sjögren's syndrome – were more common 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 on Friday and urged the public and health community to be cautious about the conclusions of the study. The statement noted concerns about "significant deficiencies" with the methodology and data presentation of the study and said "we disagree" with the conclusions.
A number of other experts in the field are echoing the FDA's concerns.
The strong response to the study was reminiscent of concerns about the safety risks of breast cancer in the 1990s and the first half of the 2000s. Allegations that cracks or leaking devices caused a variety of systemic autoimmune disorders in women, which led to huge payouts of high-profile class-action lawsuits. Dow Corning, the leading supplier at the time, declared bankrupt because of all claims against it.
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The issue was particularly big news in Houston, the birthplace of the breast implant and the site of some of the biggest prosecutor's victories, many of which were secured by the late John O & # 39; Quinn, the famous trial lawyer in Houston. Texas Monthly magazine once called Houston "Silicone City".
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The FDA promulgated a moratorium on silicone-based implants in 1992 and then lifted it in 2005 after it concluded that there was insufficient evidence to bind implants to systemic autoimmune diseases. In 2006 it approved devices from Allergan and Mentor Corp. well, but the companies were required to conduct studies on the outcomes of patients.
It was data from those studies that were made public last year and that were analyzed by the MD Anderson team.
Faced with criticism, Clemens said that the team "is behind the data and thinks that these are the best data we have so far." He stressed that the findings were consistent with previous implant safety studies and added that 90 percent of patients satisfied or satisfied were very satisfied with their decision to get the device.
Clemens said he was convinced that his team and the FDA will see a similar path in the future – not just the planned public meeting in 2019, but also the establishment of a national registry for breast implants and a call for more research.
"The study is reassuring in many ways, but I'm concerned that the parts that connect implants with rare diseases can alert women too much," said Dr. Andrea Pusic, chairman of plastic surgery in Brigham and the Women & # 39; s Hospital in Boston and president-elect of the American Society. from plastic surgeons. "They had to be interpreted carefully."
The study criticized what, according to experts, were fundamental shortcomings in the data used for the study. That included inconsistent sources of results – one manufacturer required a doctor's diagnosis of a complication; the other took care of the patient's judgment. As a result, disease risk figures can vary dramatically, although the gels used by the companies are comparable.
More than half of the women in the second year also dropped out of the study, which according to Pusic often happens when patients feel healthy. Their lack of updated results has probably skewed the results, she said.
In the paper, the MD Anderson team acknowledged that limitations in the data.
Annals of Surgery is a monthly journal of surgical science that has existed since 1885. The journal has published an FDA editorial about the study and a very critical commentary written by plastic surgeons at the Massachusetts General Hospital and Memorial Sloan Kettering Cancer Center in New York. One of the two surgeons is a consultant for Allergan.
David Bernstein, a professor in the rights of Professor George Mason and a silicone historian, said he does not think the study would lead to new lawsuits because some data "reject the statement", such as a link between implants and a lower risk of fibromyalgia . He said that a lawyer who defends a manufacturer who is being prosecuted for a slight increase in rheumatoid arthritis related to implants could easily undermine such arguments by pointing to the possible protective benefit of fibromyalgia in the study.
Approximately 400,000 women receive implants every year, most of them silicone. The vast majority – about 85 percent – is for cosmetic reasons, the rest for reconstruction after cancer surgery.