According to a new study from Northwestern Medicine published in the journal Obstetrics and Gynecology, 22% of a series of high-risk medical devices approved for use in women between 2000 and 2015 won FDA approval based on flawed safety data.
Investigators analyzed the clearances for certain high-risk devices in the subject period and discovered that 4 out of 18, or 22% of the total, had received approval despite a failure to show effectiveness in clinical trials. Six more devices from the set — another 33% — were not required to undergo post-market studies after their release — studies usually made to gather additional information about a product’s safety, efficacy, or optimal use.
According to the study’s authors, “We looked at the class of devices with the highest potential risk to patients — the devices that had to go through the most rigorous pre-market approval process. Despite this being the most stringent pathway, and despite the fact that we’ve had multiple safety issues connected to OB-GYN devices affecting millions of women worldwide, the evidence leading to approval has a lot of weaknesses.”
…despite multiple safety issues [in] OB-GYN devices affecting millions of women worldwide, the evidence leading to approval has a lot of weaknesses.”
Three of the studied devices were ultimately pulled from the market after their initial approval. The study’s authors highlighted certain controversial medical devices, such as Bayer’s Essure contraceptive device, whose current evaluation path is marred by numerous adverse event reports — reports of injuries or serious side effects relating to a medical device or product.
[S]hould we really be holding high-risk medical devices to a lower standard of evidence than drugs?
Of equally great concern is the 21st Century Cures Act, whose pending approval could further deregulate medical devices, potentially leading to approvals and clearances based on even less clinical evidence.
Contact National Women’s Injury Attorneys at Lieff Cabraser
Lieff Cabraser represents hundreds of women nationwide in cases involving injuries from medical devices and products like transvaginal surgical mesh and power morcellators that have spread cancer through their bodies. Our attorneys approach these cases with expertise and great sensitivity, and any information you provide is held in the strictest confidence. Please contact us online or call us toll-free at 1 800 541-7358 and ask to speak to attorney Wendy Fleishman or Sarah London. There is no charge for our review of your potential injury case.