Largest Study Ever Shows Link Between Breast Implants And Autoimmunity

Just when the question of whether silicone breast implants cause health problems seemed to have been answered, the results of the largest study ever conducted on the subject are in. While generally considered safe, it has been confirmed that silicone implants can up the chances of certain disorders.

Nearly 100,000 implant patients cooperated in the study, conducted by MD Anderson Cancer Center researchers. While federal health regulators claim to disagree with the claims, they have scheduled a public meeting of medical advisers to consider implant safety next year. “These findings aren’t meant to suggest implants caused these problems,” said Dr. Mark Clemens, 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.”

Clemens’ research team discovered that four specific health problems occurred more frequently in patients with silicone implants than in patients without. Those four disorders are melanoma, rheumatoid arthritis, scleroderma, and Sjogren’s syndrome. The FDA issued a statement in response to the new study, urging the public to consider that there are concerns about “significant shortcomings” within the study’s data. The administration claims to outright disagree with the study’s findings.

A number of other experts in the field agree with the FDA. In the 1990s and early 2000s, allegations that leaking silicone implants were causing several autoimmune disorders in women led to several high profile class action lawsuits. The leading supplier of the implants in question, Dow Corning, ended up filing for bankruptcy due to the high number of claims.

Houston, TX, the birthplace of silicone breast implants, was home to some of the largest plaintiff victories in class action suits. John O’Quinn, the famed Houston trial lawyer, represented many of the injured parties. In 1992, the FDA declared a moratorium on silicone-based implants, which remained in effect until 2005, after it concluded that there was not sufficient evidence tying the implants to the autoimmune disorders in question. In 2006, the FDA approved implant devices, but required the companies who produced them to conduct studies on patient outcomes. It was this data that the recently published study researched.

Unnecessary Alarm?

Once faced with the criticism of his study, Clemens insisted that his team stands behind the data. He pointed out that the findings of this study were consistent with previous implant safety studies. Both showed that the vast majority of implant patients do not go on to suffer health problem because of their breast implants.

The doctor shared his excitement about the planned 2019 public meeting and also about the establishment of a national breast implant registry. Plus, of course, the 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. Pusic, President-elect of the American Society of Plastic Surgeons. “They needed to be interpreted carefully.”

The criticism the study drew from experts was due to supposed fundamental flaws in the data used for the research, including inconsistent sources of outcomes. While one implant manufacturer required a doctor’s diagnosis of a health complication to include it as an outcome, the other manufacturer simply took the patient’s word for it that they were suffering from a certain condition.

More than half of the women dropped completely out of the study by the second year. This generally means that there were no ill effects being experienced. The MD Anderson team noted these data limitations within the study. Still, the study was by hailed by the National Center for Health Research in Washington. “The findings are consistent with what thousands of women with breast implants have reported in Facebook groups and other social media, and directly challenge the FDA’s claims that breast implants do not cause such diseases,” said Diana Zuckerman, President of the center.

Zuckerman asked that the FDA be “more patient-centered and finally require independent studies be conducted of women before and after their breast implants are removed.” She noted that while many women have reported that their problematic symptoms resolved after implant removal, there simply isn’t enough scientific data to prove it.

David Bernstein, silicone historian and law professor at George Mason University insists that the data in the new study “defies explanation” and will not be the basis of any new lawsuits against breast implant manufacturers. For example, the study notes a slightly decreased risk of fibromyalgia in patients with silicone implants.

The Dow Corning Breast Implant Settlement

If you filed a claim on or before June 3, 2019, you may still be a candidate for a settlement based on the harm Dow Corning Implants have caused you. Women across the country have received and continue to receive settlements from Dow due to damage and illness caused by implant rupture and leakage. This is a company that preyed on women’s insecurities and provided them with implants known to cause debilitating autoimmune disorders. Dow is ending these settlements and the last day to file a claim will be June 3, 2019.

If you filed a claim, even many years ago, for the rupture or leakage of silicone breast implants, you very well may still be eligible for compensation. However, time is running out. You are required to submit claim forms and medical records on or before June 3, 2019 in order to recover for injuries associated with these breast implants. Take action now.

Heath complications known to be associated with Dow Corning silicone breast implants include scleroderma, connective tissue disease, lupus, and other autoimmune diseases. If you think you may have any of these health issues as a result of your Dow Corning breast implants, it is important to first contact a doctor and then contact The Law Offices of Fenstersheib & Berkowitz.

Attorney Sheryl E. Berkowitz

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