After being diagnosed with breast cancer in her mid-40s and undergoing a mastectomy, Caroline made the decision to undergo breast reconstruction surgery. In 2015, she underwent surgery in which Allergan’s Biocell textured implants were implanted into her body. She believed the implants were a part of her healing and recovery, to restore her normal life.

Five years after her breast reconstruction surgery, when a cancer victim is generally declared a survivor and cancer-free, Caroline received devastating news: her breast implant itself had caused a new cancer to develop in the fluid around the implant. After several invasive tests, Caroline learned that she had become the victim of a type of non-Hodgkin’s lymphoma known as anaplastic large cell lymphoma (or “ALCL”), which occurs only in the presence of textured breast implants.

What came next was a nightmare for Caroline. She had to undergo yet another surgery in which her breast implant was removed. In addition to removing her breast implant, the surgeon had to remove a significant amount of tissue from her chest wall to ensure that all of the cancer was removed so that it would not metastasize. Caroline had significant scarring as a result of the extensive surgery and lost much of the tissue in her breast cavity, leaving her chest wall horribly deformed.

Caroline is not alone. A recent study from Memorial Sloan Kettering Cancer Center in New York estimates that after 20 years, more than 1 out of every 100 women with Allergan Biocell breast implants will develop this unique type of lymphoma. Many of these women will not be as lucky as Caroline. If not caught early, BIA-ALCL can be fatal.

A “Fingerprint” Disease Primarily Linked To Allergan’s Biocell Implants

The World Health Organization has designated Breast Implant-Associated Anaplastic Large Cell Lymphoma (or “BIA-ALCL”) as a distinct disease entity. This lymphoma is a unique disease that occurs only in women who have breast implants. Like other cancers, the treatment course for BIA-ALCL often includes surgery, chemotherapy, and/or radiation. In some cases, it can spread to the lymph nodes or throughout the body. If found in an advanced state, BIA-ALCL has a dismal prognosis and a high mortality rate.

BIA-ALCL does not occur in the presence of all types of breast implants. Instead, it occurs only in women who have a history of textured breast implants. The disease has not been seen in women who had only smooth breast implants (implants without texture) or in women without a history of breast implants.

Allergan’s Biocell implants were used by almost all of the women who have been diagnosed with and have died from BIA-ALCL. For example, of the cases of BIA-ALCL for which the FDA has been able to identify a manufacturer, 91 percent of the women diagnosed with BIA-ALCL and 98 percent of the women who have died from BIA-ALCL used Allergan’s Biocell textured implants.

Allergan’s Knowledge

At the time of Caroline’s surgery in 2015, Allergan knew that a concerning number of women with its Biocell textured breast implants had been diagnosed with BIA-ALCL. Allergan first became aware that its textured implants were associated with this unique disease in 1997 when the first case report was published. Over the next several years, Allergan would learn about more cases involving the Biocell implant.

By 2015, when Caroline underwent surgery to implant her Biocell implants, Allergan knew that the women in its own clinical studies had an alarming number of BIA-ALCL cases. And Allergan knew from the reports of other cases that BIA-ALCL typically takes around five to ten years to develop. Yet, after an average of only 3 years of follow-up, four of the 17,656 women in Allergan’s clinical studies had already developed BIA-ALCL. Allergan ignored this shocking data and declared instead that its clinical study results “reaffirm the safety” of the Biocell implants. Had Caroline known the truth about what the studies showed and the significantly increased risk she had of developing another malignancy, she would never have chosen Allergan’s textured breast implants.

“Struck by an Asteroid”

As word began to get out that a concerning number of women with Allergan’s Biocell implant were being diagnosed with BIA-ALCL, Allergan kicked its public relations machine into overdrive. Allergan and its consultants did everything they could to gaslight patients and the medical community to ignore the mounting evidence that its Biocell implants were associated with a deadly disease.

In its fight to keep Biocell implants on the market, Allergan minimized the risk of ALCL and mocked the doctors who took the risk seriously. In 2011, for example, an Allergan representative told CBS News that “A woman is more likely to be struck by lightning than to get this condition.” And in 2015—the same year as Caroline received her Biocell implants—a prominent Allergan consultant said that “a cosmetic implant patient is twice as likely to be struck by an asteroid as to develop implant-associated ALCL.”

The true risk, of course, was tragically higher, and Allergan knew it. By the time Allergan’s consultant claimed that a patient was “twice as likely to be struck by an asteroid,” one out of every 4,400 women in Allergan’s own clinical studies had already developed BIA-ALCL. And Allergan knew this was just the tip of the iceberg given the short follow-up period of the study. Indeed, the data now shows that after 20 years, more than 1 out of every 100 patients with Biocell implants will develop BIA-ALCL.

A Delayed Recall

Despite the mounting and undeniable evidence that its Biocell breast implants were causing hundreds of women to develop a unique type of lymphoma, Allergan continued to sell the implants, and it fought any effort to remove them from the market.

It took regulators from outside the United States to get the FDA to pay attention. In April 2019, both the French health regulator (ANSM) and the Canadian health regulator (Health Canada) banned the sale of Biocell and other macrotextured breast implants. Three months later, in July 2019, the US FDA finally demanded that Allergan recall its Biocell textured breast implants.

By the time Allergan recalled its Biocell implants, hundreds of thousands of Biocell implants had been surgically implanted into the bodies of women around the world. Based on the Memorial Sloan-Kettering data, it is only a matter of time before many of those women develop BIA-ALCL. Allergan defends its actions in part by downplaying the seriousness of BIA-ALCL. It claims that it is “rare,” that it is “slow-growing,” and that it is “readily treatable.”

We know now that it is far from rare, that it can grow at varying time frames, and that it is only “readily treatable” if caught early. Even when caught early, patients still require extensive surgery and general anesthesia and encounter the risks associated with both. Women will undeniably suffer, and women will undeniably die, and this is all because Allergan chose to hide the truth and failed and refused to recall this dangerous Biocell product sooner.

Women Often Pay The Price For Corporate Greed

Sadly, this is just another chapter in a long and tragic history of women being disproportionately injured by the actions (and inactions) of medical device manufacturers, doctors, and the FDA.

From ancient Greece—when Aristotle claimed that a woman’s body is just the inverse of a man’s—all the way through modern times, there are countless examples of the medical establishment mistreating women and forcing them to suffer disproportionate health consequences. One needs only look to Dalkon Shield, vaginal mesh, Ortho Evra, and now Biocell textured breast implants to prove the point. Even though the disparities in women’s health have long been recognized, few serious efforts have been made to address them, and those few efforts have fallen short. For example, the FDA established the Office of Women’s Health nearly 30 years ago to address the inequities in women’s health. It sought to address and correct the inadequacy of educational efforts directed toward women’s health issues and to remedy women being excluded or minimally included in medical research and clinical trials. Yet, in a 2019 study of medical device-related injuries and deaths reported to the FDA (Lenzer, J. The Danger within Us, 1st ed.; Little Brown and Company: New York, NY, USA, 2017), researchers found that a vastly disproportionate share—67 percent—involved women.

While not the only cause, the historic absence of women from leadership positions in medical device companies certainly is part of the problem. Research (Kaitlin D. Wowak , George P. Ball , Corinne Post , David J. Ketchen Jr. (2020) The Influence of Female Directors on Product Recall Decisions. Manufacturing & Service Operations Management 23(4):895-913) shows that companies with more women serving on their boards of directors have safer products and recall dangerous products faster than companies with fewer women in these leadership positions.

Inamed—the company that developed and first sold the Biocell textured implant—did not have a single woman serving on its board of directors even though the company’s products were primarily targeted to women. Instead, Inamed was led by a man named Donald McGhan, who later was sentenced to 10 years in a federal prison for his part in a $97 million fraud.

We Can Do Better

Caroline and all of the other women who have suffered from—and died from—BIA-ALCL deserved to be protected. They did everything they were supposed to do. They were misled into believing that they were getting the safest, most advanced, reliable and technologically advanced implants available. What they got instead was a recipe for disaster. A disaster that was entirely avoidable.

The medical community should have protected them, not minimized a deadly disease with bombastic lies about asteroids and lightening. The FDA should have protected them by not allowing the deaths to mount before forcing a recall. But more than anything, the companies like Allergan that sold these implants to women—including breast cancer survivors like Caroline—had an obligation to protect these women, not continue to push dangerous implants all in the name of corporate profits.

What We Are Doing

The Biocell victims have not simply accepted their fate as victims. Caroline and many others like her are pursuing claims against Allergan in the Multidistrict Litigation before the Honorable Brian R. Martinotti in the United States District Court for the District of New Jersey. Some Biocell patients are pursuing claims in the corresponding state-court litigations in New Jersey and California as well. It is important to Caroline and other victims of these dangerous products to get answers and to hold Allergan accountable.

By Brian Devine, Co-Chair of the Science and Expert Committee, and Virginia M. Buchanan, Co-Lead Counsel of the Biocell Textured Breast Implant Litigation MDL