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The largest study ever conducted on silicone breast implants revealed that devices are generally safe but associated with a slightly higher risk of some rare diseases, a controversial finding that quickly warmed the seemingly solved problem.
Researchers at the MD Anderson Cancer Center, based on the results of nearly 100,000 patients who have received one of the devices since their return to the market in 2006, were challenged on Friday by many experts, a meeting of medical advisers. next year to review implant safety.
"These findings are not intended to suggest that implants have caused these problems," said Dr. Mark Clemens, MD Anderson MD Professor of Plastic Surgery and Principal Investigator of the study. "These are associations that emphasize the need for more research in this area, but provide critical safety information for women and their providers when considering cosmetic or reconstructive surgery with breast implants." .
The Clemens team reports that four health problems – skin melanoma and autoimmune diseases, rheumatoid arthritis, scleroderma, and Sjogren's syndrome – have appeared more often in patients with higher blood pressure. implants in silicon gel. in the general population. The numbers were small but statistically significant, said Clemens.
The Food and Drug Administration released a statement Friday urging "the public and the health care community to view the findings of the study with caution." The statement highlighted concerns about "significant gaps" in the methodology and presentation of the data. respectfully disagree with the findings.
A number of experts in the field have echoed the concerns of the FDA.
The strong response to this study is reminiscent of the safety concerns posed by breast implants in the 1990s and the first half of the 2000s. The claims of rupture or leakage of the devices have caused a variety of autoimmune systemic disorders in women resulting in significant spin-offs in leading class actions. Dow Corning, the main supplier of the time, declared bankruptcy because of all the claims against it.
RELATED: FDA advisors take position on silicone breast implants
The issue was particularly topical in Houston, birthplace of the breast implant and site of some of the biggest victories of the plaintiffs, many of which were won by the late John O'Quinn, a famous trial attorney. from Houston. Texas Monthly magazine has already nicknamed Houston "Silicone City".
RELATED: Invention has made Houston the world's center for breast implants
The FDA declared a moratorium on silicone-based implants in 1992, and then lifted it in 2005, after concluding that there was not enough evidence to bind the implants to the disorders systemic autoimmune. In 2006, he approved the Allergan and Mentor Corp. appliances, but required companies to conduct outcome studies for patients.
Data from these studies, released last year, were analyzed by the MD Anderson team.
Undue alarm?
Faced with criticism, Clemens said the team "supports the data and thinks it's the best data to date." He pointed out that the results were consistent with previous studies on implant safety and that 90% of patients were satisfied or very satisfied with their decision to get the device.
Clemens said he is encouraged by the fact that his team and the FDA are considering a similar process – not just the public meeting scheduled for 2019, but also the creation of a national registry of breast implants and a call for more of research.
"The study is reassuring in many ways, but I am afraid that parts associating implants with rare diseases may unduly alarm women," said Dr. Andrea Pusic, president of plastic surgery at the University of California. Brigham Hospital and Women's Boston. plastic surgeons. "They had to be interpreted with care."
The study was criticized for what experts have described as fundamental flaws in the data used for research. These included inconsistent sources of results – a manufacturer required a medical diagnosis of a complication; the other took the patient's judgment at face value. As a result, the disease risk rates could differ significantly, even if the gels used by the companies are similar.
In addition, more than half of women dropped out in the second year, which Pusic often found when patients feel healthy. Their lack of updated results likely distorted the results, she said.
In the paper, the MD Anderson team recognized these limitations in the data.
Annals of Surgery is a monthly journal of surgical science that has existed since 1885. The journal published an FDA editorial on this study as well as a very critical comment co-authored by plastic surgeons from Massachusetts General Hospital and Memorial Sloan. Kettering Cancer Center. New York. One of the two surgeons is a consultant to Allergan.
David Bernstein, a law professor at George Mason University and a silicone historian, said he did not think the study would lead to new litigation because some data "defend any explanation", such as an association between implants and a lower risk of fibromyalgia. According to him, a lawyer defending a manufacturer sued for a slight increase in rheumatoid arthritis associated with implants could easily undermine such arguments by stressing the usefulness of the device for protecting fibromyalgia in the study.
Approximately 400,000 women receive implants each year, most of them silicone. The vast majority – about 85% – are for aesthetic reasons, the rest for reconstruction after cancer surgery.
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