REPORTING ON PATIENT SAFETY STORIES, particularly those involving medical devices, is tough. The road to publication or getting on-air is littered with obstacles—from federal and state regulators as well as device makers—and often constrained by the newsroom itself. Nonetheless, as the 21st Century Cures Act (which loosens regulations over medical device makers and makes it easier to market them based on lower standards) takes effect, the job of warning the public of potentially harmful consequences still falls to the media.
A recent effort by WJLA, the ABC affiliate in Washington, D.C., underscores why such journalism remains crucial. The story—a lengthy exposé about textured breast implants that are implicated in a rare type of lymphoma—is a fine piece of consumer health journalism that should give women in the Washington area a lot to think about before choosing such implants.
Questions about the safety of breast implants have been raised before, and Kimberly Suiters’ reporting shows that concerns persist. Her story, Suiters told me, grew out of another that aired a few months earlier. In that first story, Suiters reported that women with breast implants seemed to have higher suicide rates than women who did not have them. One plastic surgeon told Suiters about an apparent connection between a certain type of textured implant and lymphoma. The surgeon—a former board member at Allergan, which manufactures implants—mentioned his concerns over the possible link to the manufacturer. He also shared those concerns with Suiters, which prompted her to dig deeper.
One local physician, who said women like the textured implants for their more natural look, argued on camera, ‘It’s still an extremely rare situation. You don’t want to yell “fire” in a theater when there’s no fire.’
Last year, the World Health Organization classified the lymphoma as a new type: breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Recently, the National Comprehensive Cancer Network developed the first international standard for BIA-ALCL’s diagnosis. A French regulatory agency warned of a “clearly established link” between implants and cancer.
However, Suiters reported in January that the U.S. Food and Drug Administration was “not prepared to say that the textured breast implants…cause lymphoma.” She noted that, in 2011 and in 2016, the FDA warned the public of a “possible association” between implants and BIA-ALCL.
This week, the FDA adjusted its stance. The agency released a statement saying that it had “strengthened [its] understanding of this condition,” and agreed with the World Health Organization that the rare lymphoma can develop following breast implants, and occurs more frequently following implantation with textured (rather than smooth) surfaces.
Suiters’ story included 40-year-old Raylene Hollrah, a breast cancer survivor who received the breast implants during reconstructive surgery and learned last year that she had BIA-ALCL. Hollrah, who has created a foundation to push for mandatory warnings for women who have implants or are considering them, told Suiters she did not recall her surgeon mentioning the small risk of cancer. “I did everything to keep cancer away,” she told Suiters. “Yet I put a device in my body that caused cancer.”
The theme of risk disclosure runs through Suiters’ recent WJLA piece, and may be its most important contribution to the public understanding. How often are women told about the risks of developing BIA-ALCL after they receive breast implants? For that matter, how often are patients told about the risks of any medical devices put into their bodies? And where can they look for information?
To help answer those questions, Suiters consulted Dr. Mark Clemens, a member of the plastic surgery faculty at the MD Anderson Cancer Center and one of the world’s experts on ALCL. Clemens’ research, noted Suiters, revealed that patients never think to ask about ALCL, and only one one-quarter of surgeons always discuss the risk of the disease with patients during initial consultation.
Suiters also asked several plastic surgeons about disclosing risks of developing BIA-ALCL. Of the plastic surgeons she spoke to, “many…expressed deep concerns about unnecessarily scaring women and limiting their options.” One local physician, who said women like the textured implants for their more natural look, argued on camera, “It’s still an extremely rare situation. You don’t want to yell ‘fire’ in a theater when there’s no fire.”
How rare is the disease? The station submitted a FOIA request to the FDA and received documents “representing 441 cases, more than one-third unconfirmed and at least 12 deaths.” In its recent statement, the FDA said it had “received 359 medical device reports about BIA-ALCL, including nine deaths.” Suiter notes that data discrepancies arise because of the way that device problems are reported—for instance, one record noted a “patient device incompatibility” but not a patient’s death. Suiters compared the lifetime risks of developing ALCL in the U.S. (one in 30,000) with Australia (one in 1,000); a former FDA analyst told her that the statistical difference proves the disease is underreported.
Dr. Sanket Dhruva, a Yale Clinical Scholar whose research has included device regulation, also questioned those numbers. “It would be surprising if there were a 30-fold higher risk in Australia,” he told me. “It means we may be missing some reports.” What’s needed, Dhruva says, are studies that follow women who receive implants for five years to see what happens. Those studies take time and money—both of which are in short supply in Washington, where the focus is on cutting the budget and lowering regulation.
Still, Dhruva says, we need more accurate data, and women considering the implants must be fully informed of their risks. “This is not a minor transient risk,” he says. “This is cancer.”
WJLA has a long history of good consumer watchdog journalism. In the current regulatory climate, the kind of reporting that Suiters and the station delivered is needed more than ever.