The number of medical device reports sent to the FDA concerning issues with breast implants was kept artificially low through the use of summary reporting, according to a new report from the Honolulu Star Advertiser.
Between 2008 and 2015, the FDA received an average of approximately 200 medical device reports related to breast implants, significantly lower than the thousands the agency had come to expect prior to those dates, according to the report.
The lowered number of reports was due to a change at the FDA which allowed manufacturers of such devices to report issues in bulk, meaning a single filed report with the FDA could represent thousands of individual cases, according to the Star Advertiser.
Last year, however, the FDA instructed manufacturers to go back and file a single individual report for each case of patient injury after a lawyer’s discovery reported that his clients weren’t represented in the FDA’s databases, according to the report.
In the last half of 2017, the FDA received more than 4,000 injury reports related to breast implants. Another 8,000 reports followed during the first six months of this year, the Star Advertiser reports.
“It looked like these devices had become safer, but they hadn’t. The data was hidden. It’s a deceptive practice,” patient safety advocate Jamee Cook, who had textured saline breast implants removed after experiencing a number of health issues, told the Associated Press.
Public health advocates involved in the debate claim that summary reporting can be used to hide such data from patients and make devices seem safer, according to the report.
In August this year, the FDA made an adjustment that will allow 90% of all medical devices, including breast implants, to report malfunctions that don’t involve deaths or serious injuries in a quarterly tally instead of individual reports, the Star Advertiser reports.
The agency itself has dismissed claims that grouped reporting could create further issues or reduce transparency, saying that it believes the benefits will outweigh the negatives.
Earlier this month, the FDA laid out plans for improving post-market medical device oversight, including a significant investment in its new National Evaluation System for health Technology.
Registration is open for DeviceTalks Boston! Join us on June 5-6, 2019, as we explore the trends and technology that are shaping the future of the medical device industry.