| The plastic implant is just a few centimeters long. It’s hard to fathom that it could create such torment, but hundreds of women say the device, called BioZorb, caused them excruciating pain, infections that wouldn’t heal and resulted in deformed breasts despite claims otherwise.
The US Food and Drug Administration approved BioZorb in 2012 as a radiographic marker for use after breast cancer surgery. Its plastic part was supposed to dissolve and leave behind tiny pieces of titanium that would show up on imaging machines to mark where a tumor had been removed. The two companies that sold BioZorb pushed it as something more — a device that would provide scaffolding for women’s breast tissue to grow back in a more aesthetically pleasing way before the plastic dissolved.
Except in many cases the plastic didn’t dissolve. And the companies kept breast cancer survivors’ complaints from the FDA and the public, some for as long as a decade. I was able to figure this out with my colleague Tanaz Meghjani, a data expert. She helped me analyze an FDA database of complaints about medical devices, which Hologic Inc., BioZorb’s most recent and last maker, only recently began updating after lawsuits were filed.
Manufacturers are supposed to turn over to the FDA any complaints they get within 30 days if they could reasonably be linked to one of their products. In BioZorb’s first seven years on the market, the company that sold it, Focal Therapeutics, received more than 100 complaints about the device. Focal only reported one of those.
Hologic, a giant in women’s health, bought Focal near the end of 2018. Still, not many complaints surfaced. That is, until a series of events put FDA officials at the company’s doorstep last year. Read our story here.
Hologic said in an emailed statement that “clinical evidence demonstrates that BioZorb is safe and effective.” The company said it’s committed to meeting the highest standards of patient safety.
While the buried complaints kept BioZorb on the market for longer than it might have been, there are also questions about how it came to market in the first place. The FDA regulates most medical devices with a light touch. The agency doesn’t even require clinical trials for the vast majority of them, including ones that are implanted in our bodies.
“People assume if it’s on the market, it’s safe and effective and it was studied, but that isn’t the case,” said Rita Redberg, a professor at the University of California, San Francisco, School of Medicine who’s been critical of the FDA’s medical device oversight. In an emailed statement, the FDA said “patient safety is of the highest priority” and that once a device is approved the agency uses “a multifaceted approach” to ensure the safety and effectiveness of devices. Last October, Hologic recalled unused BioZorb devices and the FDA warned consumers and health-care providers not to use them. Hologic previously told the FDA it didn’t plan further research on BioZorb even though the agency raised questions about whether any of the 90,000 women who had the device implanted should have it removed, according to a December warning letter the agency sent the company. I asked Hologic to explain this decision, but the company has only said they are working with the FDA to address its letter. — Anna Edney |
