The 7 Investigators obtained records from the Food and Drug Administration (FDA) showing that the original manufacturer of a permanent birth control device, Essure, knew patients were being harmed by the device more than a decade ago.
At the time, the device was made by Conceptus. They were cited more than once by the FDA for failing to report all of the complaints about Essure within the 30 day time period allowed by law.
“I have no idea how safe this medical device is and neither does anybody else,” said Dr. Diana Zuckerman, President of the National Center for Health Research.
Essure is marketed as permanent birth control without surgery. During the procedure, two metal coils are placed inside the fallopian tubes. Over the next three months, scar tissue is supposed to amass around the coils, blocking conception. The 7 Investigators have been reporting about Essure for nearly a year, after dozens of women came forward to share their stories. Common complaints include bloating, rashes and chronic pelvic pain. Women also reported serious issues they say resulted from Essure, such as miscarriages and ectopic pregnancies. In many cases, the coils perforated the fallopian tubes and needed to be removed. Many had hysterectomies.
Conceptus was inspected twice by the FDA, in 2003 and again in 2010, according to records obtained from the FDA. In both instances, the company was issued what are called Form 483s. They are issued after an FDA inspection to firm management, “when an investigator has observed conditions that may constitute violations of the Food, Drug and Cosmetic Act…or any related acts,” according to the FDA’s website.
The FDA refused to comment on the forms, but their website describes them as a form that “notifies the company’s management of objectionable conditions.”[…]
But, what got the attention of Zuckerman and Carome are records from 2010, showing the company failed to report adverse events or injuries that may have been caused by the device to the FDA.
“It’s clear that the FDA inspectors found that the company wasn’t being forthcoming in reporting problems that patients were having,” Zuckerman said.[…]
These records have Dr. Zuckerman with the NCHR questioning the original clinical trials.
“When you see data that looks so great and you talk to women who have used the product whose experience is completely different, you have to question whether the studies were really done appropriately,” she said.
The FDA told 7 Action News the follow-up studies to the clinical trials have been completed. At the time the device was originally approved by the FDA in 2002, FDA spokesperson Jennifer Rodriguez said, “The FDA had one to two years of safety and effectiveness outcomes data for Essure,” and that the FDA advisory panel unanimously recommended that the device be approved.
But, Zuckerman said clinical trial studies are frequently based on too few people, studied for too short a period of time.
“The data make it look like a product is safer or more effective than it really is,” Zuckerman said.