The U.S. Food and Drug Administration (FDA) issued a recall this week of breast implants produced by pharmaceutical company Allergan, citing an increased risk of cancer among patients with implants manufactured by the company.
The FDA found that people with Allergan BIOCELL textured breast implants had an increased risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Symptoms of the rare form of cancer include swelling and pain around the implant.
“Once the evidence indicated that Allergan’s product appeared to be directly linked to significant patient harm... the FDA took action to alert the firm to new evidence and that the recall is warranted,” FDA Principal Deputy Commissioner Amy Abernethy told journalists.
Allergan has stated that they will comply with the new recall order and stop the sale of BIOCELL saline-filled and silicone-filled implants worldwide. But Allergan is facing lawsuits from consumers who claim the corporation knew about the link between their products and BIA-ALCL as early as the 1990s but continued to sell and promote their products without informing the public of health risks posed by the implants. In 2018, women filed lawsuits against Allergan in New Jersey and California.
There is a history of litigation against breast implant manufacturers for personal injury to consumers, with courts awarding consumers as much as $250,000 in the case of an implant-related condition. In the 1980s and 90s, U.S. courts found drug companies liable in class-action lawsuits worth billions of dollars, including a 1998 ruling against Dow Corning Corp. worth $3.2 billion. The court ordered Dow Corning to compensate women for the cost of removing the implants as well as personal injury and litigation against the company forced them to declare bankruptcy.
In 2016 and 2017, two women sued Mentor Worldwide, a Johnson & Johnson subsidiary, in California courts alleging they had developed conditions as a result of Mentor MemoryGel silicone breast implants. Consumers have brought litigation against Allergan as recently as last month.
The FDA has been studying the risks associated with textured implants for years. In March, they held two days of hearings with testimonies from women who alleged that they had developed cancer as a result of their implants. Women reported symptoms including chronic fatigue, hair loss, intestinal issues, and unexplained rashes and itching.
“Cancer was not a choice,” said one woman at the hearings. “And we sure as heck didn’t elect to get it.”
In March, however, the FDA determined that existing data didn’t establish a strong enough link between implants and cancer and declined to issue a recall.
But new research has found that out of 573 cases of BIA-ALCL around the world, 481 of the patients were reported to have Allergan breast implants. Out of 13 fatal cases of BIA-ALCL in which the manufacturer of the implants was known, 12 were the result of Allergan implants. The FDA issued last week’s ban after the new data established a higher level of serious health risks to consumers.
“We have worked to increase awareness and encourage reporting of all cases to the FDA,” said Abernethy. “Based on new data, our team concluded that action is necessary at this time to protect the public health.”
The risk of developing BIA-ALCL was about six times higher for patients with Allergan BIOCELL textured implants than it was for patients with textured implants from other manufacturers. Patients with implants from cosmetic surgery and those who receive them during post-mastectomy reconstruction both appear to be at risk to develop the condition.
Allergan’s implants were taken off the market in Europe in December 2018 and have also been banned in Canada and Australia. The FDA stated that they would continue their assessment to determine if other models of macro-textured breast implants on the market pose a health risk to patients. In the U.S., textured implants are also sold by Johnson & Johnson and Sientra.
BIA-ALCL is a type of non-Hodgkin’s lymphoma—a cancer of the immune system, rather than breast cancer. BIA-ALCL forms within scar tissue and fluid that surround the implant.
Researchers have so far been unable to explain the mechanism behind the link between the macro-textured implants and the lymphoma condition.
The FDA did not advise patients with Allergan BIOCELL textured breast implants to have their implants removed unless they show symptoms.
Physicians can diagnose BIA-ALCL through a physical exam, an assessment of fluid and tissue in the implant area, and imaging techniques. The FDA did recommend that anyone who is diagnosed with BIA-ALCL should consult a surgeon to have their implants and the surrounding scar tissue, sometimes called the capsule, removed. Some cases will require chemotherapy or radiation treatment.
Many physicians are supportive of the FDA’s decision to issue a recall.
“We have tried to give them all the data and the information that they need to make this decision,” said Dr. Mark Clemens, a plastic surgeon at the M.D. Anderson Cancer Center in Houston.
Macro-textured breast implants account for less than 5 percent of implants sold in the U.S., according to the FDA. The recall includes Allergan Natrelle Saline-Filled Breast Implants (formerly McGhan RTV Saline-Filled Mammary Implant), Allergan Natrelle Silicone-Filled Textured Breast Implants, Natrelle Inspira BIOCELL Implants, and Natrelle Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants as well as the company’s Tissue Expander and Plus Tissue Expander. The full list of models and product numbers is published here by the FDA.