WASHINGTON – To all the world, it looked like breast implants were safe. From 2008 to 2015, the U.S. Food and Drug Administration publicly reported 200 or so complaints annually — a tiny fraction of the hundreds of thousands of implant surgeries performed each year.
Then last fall, thousands of problems with breast implants flooded the FDA’s system. More than 4,000 injury reports filed in the last half of 2017. Another 8,000 in the first six months of 2018.
Suddenly, women like Jamee Cook had evidence suggesting their suffering might be linked to their breast implants. An emergency room paramedic, Cook had quit her job because of a vague but persistent array of health problems that stretched over a decade, including exhaustion, migraines, trouble focusing and an autoimmune disorder diagnosis. Why had it taken so long for complaints like hers to see the light of day?
Makers of breast implants were required to track patients and their health. But for more than a decade, manufacturers with high numbers of recurring problems — in the case of implants, ruptures that required surgery to remove — were allowed to report issues in bulk, with one report standing in for thousands of individual cases and no way for the public to discern the true volume of incidents.
That agreement stood even as the FDA began closely monitoring a rare type of cancer and acknowledged in 2011 that it might be linked to breast implants.
“It looked like these devices had become safer, but they hadn’t,” Cook said. “The data was hidden. ”
Once Cook’s textured saline implants were removed, she said the majority of her symptoms disappeared. Her experiences prompted her to become a patient safety advocate.
Public health advocates who’ve watched the debate over breast implant safety rage for nearly three decades say summary reporting is yet another way that information about the devices has been elusive for patients. “They were told those devices were safe — the FDA would go back and say ‘We only have this many reports,’ ” said Madris Tomes, a former FDA staffer who founded a company to analyze medical device reports. “But data was coming in another way that wasn’t public.”
The data came to light after the FDA instructed manufacturers in mid-2017 to go back and file individual reports in each case of patient injury, in response to a lawyer’s discovery that reports from his clients weren’t represented in the agency’s data. But even as the FDA was dealing with the problems of how breast implant manufacturers had used summary reporting, the agency was moving to expand device makers’ flexibility in how they report problems, saying it was trying to reduce paperwork requirements.
This August, the agency began allowing roughly 90 percent of all medical devices — including all breast implants and more than 160 types of other high-risk implanted devices like artificial hips and replacement heart valves — to report malfunctions in a quarterly tally, instead of individually. They will not be able to report cases involving deaths or injuries that way, however.
The FDA rejected claims that expanding summary reporting could limit transparency and harm public health, saying the plan “will also yield benefits, such as helping FDA process malfunction reports more efficiently and helping both FDA and the public more readily identify malfunction trends.”
FDA officials also said the agency has monitored the breast implant industry in the past decade and issued updates about potential risks.
Two of the largest breast implant manufacturers, Mentor and Allergan, said they stood behind the safety of their products, citing years of studies that have led to inconclusive evidence that autoimmune problems are linked to breast implants.
“Our medical devices undergo extensive laboratory testing before they are submitted to government health experts for a science-based review,” Mentor spokeswoman Mindy Tinsley said. “Many of our devices undergo careful reviews by not just one, but multiple regulatory bodies around the world.”
Still, it can be hard for breast implant patients and advocates to track problems that do arise.
Insurance claims make no mention of the specific device or model implanted in a patient, and patients’ electronic health records aren’t required to record that either. In addition, products sold overseas can be renamed or carry a different model number, making international recalls or tracking across borders nearly impossible.
Meanwhile, the FDA’s main database on medical device problems, which requires manufacturers to report patient deaths and serious injuries to the government within 30 days, relies on hand-typed entries from a variety of people — from patients to device manufacturers — to help track troubled products. That can lead to underreporting, along with missing and flawed data.
Tomes said accurate, complete and publicly accessible data is crucial to identifying problems quickly and making sure devices are safe. The FDA numbers, she said, offer the lowest possible count of reports about problems with breast implants.
“You can assume that the numbers are probably much, much higher,” she said.
A Duke University report funded by the FDA in 2016 found that even though the agency collected data on device malfunctions for more than two decades, “reliably and efficiently tracking the medical device safety and effectiveness outcomes of most interest to patients remains a generally unfulfilled promise” that “significantly affects the public health.”