For the second time in less than two years, the Food and Drug Administration has warned Paragard IUD manufacturer CooperSurgical for running ads that fail to disclose Paragard’s safety risks as required by federal law.
The video of concern, “Paragard: Family Planning During The Pandemic,” ran on Boston NBC-affiliate WBTS’ “The Hub” webpage from Oct. 5, 2020 through at least Feb. 12, 2021, the date of the Paragard warning letter. The video has been removed. The FDA was alerted about the video by a complaint submitted through the agency’s Bad Ad Program.
“This misleading presentation is particularly concerning from a public health perspective due to the serious and potentially life-threatening risks associated with (Paragard),” Robert Dean, director of the Division of Advertising & Promotion Review II at the FDA’s Office of Prescription Drug Promotion, wrote.
The FDA gave CooperSurgical 15 days to respond and also criticized the company for failing to submit the video to the agency before airing per federal regulations. The FDA requested the following and threatened “regulatory action” if CooperSurgical failed to “adequately address” the situation:
- A list of all promotions that similarly fail to mention Paragard’s safety risks
- A plan to stop running those promotions or to stop distributing Paragard
- A plan for “truthful, non-misleading and complete corrective communication(s)” aimed at the original Paragard ad audience
The FDA letter described Paragard’s “most serious and most common risks,” which include menstrual abnormalities, backache, anemia, vaginal inflammation, pelvic inflammatory disease, ectopic pregnancy and the potential for Paragard to fall partially or completely out of the uterus, to puncture the uterine wall or become embedded in it, and to migrate elsewhere in the body.
In December, 55 Paragard lawsuits were transferred from 23 states to a federal court in Georgia. The lawsuits allege that Paragard can break during removal, resulting in pain, infertility and other complications and sometimes requiring surgical removal of broken-off pieces. More than 80 Paragard lawsuits are pending and more are expected.
Paragard “Bad Ad” History
In July 2019 the FDA sent CooperSurgical a similar warning letter concerning a TV ad that failed to mention Paragard’s safety risks. The FDA was likewise filed through a Bad Ad program complaint.