Rachel Rabkin Peachman, Consumer Reports: October 31, 2019
Antibiotic-resistant strains of salmonella are linked to contaminated chicken, sickening many and hospitalizing more than 200 people for almost a year and a half, though it was known that the plants processing the chicken had failed federal food safety standards. Why did the outbreak go on for so long before the unsafe chicken was pulled from store shelves?
A breast implant lacking premarket safety research is linked to a rare cancer, but years pass and women die before regulators acknowledge the connection and a manufacturer recalls the devices. Why did it take patient outcry before the potentially deadly implants were taken off the market?
An inclined sleeper for babies is put on the market without adequate safety testing or adherence to infant sleep guidelines. Over the next decade, as the sleeper becomes a best seller, dozens of babies die while using it. Why did it take public exposure before the manufacturer recalled the product?
In 21st century America, it’s easy to assume that the products we put on our plates, in our homes, and in our bodies are safe and effective. Many people expect that we have robust consumer protections in place—a system that vets products thoroughly before allowing them to be sold and that recalls products swiftly if they prove to be dangerous.
But product safety regulation and the recall process are part of a complicated and imperfect system that varies widely depending on the type of product, the industries involved, and the government agencies tasked with overseeing it. For instance, a recall does not get put into motion automatically when a product is known to cause harm. Recalls, if they happen at all, can take years to be initiated, often only after public protest and sometimes following injuries or deaths.
Moreover, when a recall is issued, consumers often aren’t made aware. Almost 70 percent of Americans said that they had not heard about a recall in the past five years for any product they own, according to a Consumer Reports nationally representative survey of 1,010 adults, though millions of products are recalled each year. And only 21 percent of Americans said they had heard about a recall and responded to it in that time frame. Of those, about two-thirds said the issue had to do with their car, 19 percent said it involved food, 9 percent a health product, and 9 percent a children’s product.
That disparity is not surprising, says David Friedman, CR’s vice president of advocacy and a former acting administrator of the National Highway Traffic Safety Administration. Unlike other federal agencies, NHTSA requires manufacturers to notify car owners directly about recalls. To track recalls, it helps that every car has a unique vehicle identification number and every owner has a registration. Other agencies—the Food and Drug Administration, the Department of Agriculture, and the Consumer Product Safety Commission—generally have fewer tools and requirements for recalls. In some cases, laws can actually shield agencies from accountability and protect companies from liability, Friedman says.
Even when consumers learn about a recall, they often aren’t given simple, effective ways to respond. Some entail disassembling and mailing in part of the product for a refund, or not using the product until a replacement part is mailed—a process that can take months. As a result, many recalled products remain in use, risking further injury.
How, then, can consumers ensure that the products they buy have been safety tested and have not caused problems since their release? In some cases, it’s impossible to fully know. But the examples described here provide a sense of how regulatory oversight sometimes works for—and against—consumers. Plus, we share steps you can take to protect yourself and your family.
Dangerous Breast Implants
Raylene Hollrah was 33 years old in 2007 when she was diagnosed with breast cancer and underwent a mastectomy. A year and a half later, when she was ready for reconstructive surgery, she chose a silicone-filled implant with a textured surface made by Allergan. Hollrah, from Hermann, Mo., believed a selling point of the implant was that she’d automatically be enrolled in a 10-year study “so I could help other women,” she says.
What Hollrah didn’t know is that medical devices—including breast implants, artificial joints, and pacemakers—are subject to much less rigorous premarket testing than drugs are. That’s partly because the FDA didn’t begin regulating medical devices or requiring research on their efficacy and safety until 1976, after many devices were already in use.
Silicone breast implants were introduced in the 1960s with little to no safety research, says Diana Zuckerman, Ph.D., president of the National Center for Health Research. Even after the FDA began regulating them, the agency didn’t require premarket studies until 1991—when it determined there was insufficient safety research, and soon after put a moratorium on sales.
In 2006, when the FDA did approve silicone implants, it was on the condition that manufacturers conduct post-market studies, one of which included Hollrah. But that wasn’t made clear to her early on. And as time passed, more problems emerged. In 2011, the FDA announced a link between silicone- and saline-filled implants and a form of cancer called anaplastic large cell lymphoma (ALCL).
But Hollrah didn’t learn about breast implant associated ALCL, or BIA-ALCL, until 2013, when one of her implants swelled and she tested positive. “I removed breast cancer,” Hollrah says, “and then I put something right back in my body that gave me cancer again.”
Around the time of Hollrah’s diagnosis, Allergan dropped her from its post-approval study. In fact, Allergan lost track of many participants, in part because it was difficult to follow up with the women, who were given no real incentives to stay involved in the studies, Zuckerman says. As a result, the research was never completed. Yet the FDA did not penalize manufacturers or recall the implants.
Fortunately for Hollrah, her cancer was caught early. She had her implants removed in 2013 and is now cancer-free.
But it wasn’t until July 2019 that the FDA announced the recall of Allergan’s textured implants due to a reported worldwide total of 573 BIA-ALCL cases, 481 of them from Allergan, including 33 deaths.
When asked why it took eight years after the FDA acknowledged the risk of BIA-ALCL for the agency to request a recall, an FDA spokesperson said it took the action after learning, in the spring of 2019, of “a significant increase in known cases of BIA-ALCL.”
Though the recall is a victory for women affected by BIA-ALCL, other concerns remain. For one, “when medical devices are recalled, there’s typically not a rigorous process to reclaim the flawed products,” says Lisa McGiffert, a co-founder of the Patient Safety Action Network and a former patient-safety expert at CR.
There’s also no established system for device manufacturers to find and notify doctors and patients about a recall. Hollrah notes that she has yet to receive a recall notification from Allergan.
For its part, Allergan says that “patient safety is a priority” and that it is committed to ensuring the safe and effective use of its products.
Still, hundreds of thousands of women are estimated to have a recalled device in their bodies and no easy choices. The FDA recommends implant removal only for women with a diagnosis of BIA-ALCL. But women don’t always have obvious symptoms. “Although BIA-ALCL is treatable if caught early, no one wants to wait to see if they get cancer,” says Sara Castro, an attorney at Farr law firm in Punta Gorda, Fla., who is working with affected women.
Another hurdle: Though Allergan will pay for replacement implants in the case of a cancer diagnosis or implant defect, it doesn’t cover the surgical costs of preventive implant removal. Most insurers won’t cover it, either.
Scot Glasberg, M.D., past president of the American Society of Plastic Surgeons and a consultant for Allergan, says that “if a woman has any concerns whatsoever, she should see a plastic surgeon who is board certified,” specializes in breast implants, and is knowledgeable about BIA-ALCL to go over her screening and testing options.
Women considering breast-implant surgery (or any medical device procedure) should ask their surgeon for an informed consent form that details what the device contains, and known risks. “This form is not mandated yet,” says Hollrah, who did not have that protection before her surgery and has since worked with Zuckerman, Glasberg, and others to develop a patient form and clearer warnings. And they have made progress on that front: On October 24, 2019, the FDA recommended that patient labeling for breast implants include a patient decision checklist, a boxed warning, an information booklet, and a patient device card. A final decision on that recommendation isn’t expected until 2020 at the earliest.
Madris Tomes, a former program manager at the FDA who now runs Device Events—which gathers adverse event reports on medical devices—recommends researching your device. One free source is an online FDA database called MAUDE (Manufacturer and User Facility Device Experience). “Two-thirds of all recalls begin as an adverse event report,” Tomes says.