Michelle Llamas, Drugwatch: June 20, 2017
Adverse events data collected from the U.S. Food and Drug Administration shows that reports of cancer linked to power morcellators are down while reports of injuries from Essure Permanent birth control are up in 2017.
Power morcellators are drill-like devices used to cut tissue into smaller pieces during gynecological surgeries. They have been on the market since the 90s, but it wasn’t until 2014 that the FDA warned about the risk of upstaging cancer. […]
“The decline in morcellator reports doesn’t mean women should be any less cautious,” [data analyst Madris] Tomes told Drugwatch. “Patients still need to ask questions.” […]
Essure Adverse Events on the Rise
While the number of morcellator cancer reports is decreasing, reports of injuries linked to Bayer’s Essure Permanent Birth Control device are on the rise.
Doctors implant Essure metal coils into each fallopian tube. After about three months, scar tissue builds up and prevents pregnancy. But since the device hit the market in 2002, the FDA received thousands of adverse events. […]
Data Reporting Problems at the FDA
There are several reasons why warnings about Essure and morcellators didn’t reach the public sooner.
One of the biggest issues is how the FDA receives and reports data on medical device adverse events. In fact, the FDA admitted it didn’t have the current data on the device at a 2016 meeting to discuss Essure device safety, according to Tomes.
In 2016, the FDA reported five deaths linked to Essure. Tomes did an independent data review and found more than 300 fetal deaths and more than 10,500 adverse events.
It highlighted a big problem with how the FDA managed injury reports. It also called into question how reliable the agency’s reports are. […]
To complicate matters, device manufacturers may also be holding back information. […]
Advocacy Remains a Key Force in Reducing Adverse Events
Madris Tomes attributes a number of factors to the decline in morcellator reports, including refusal of insurance companies to pay for morcellator surgeries, hospitals banning the device and FDA safety communications.
But the personal stories and convictions of women affected by these devices led to the most action. […]
Legislation Aimed at Making Devices Safer, Preserving Legal Rights
Because of women and their families who spoke out about morcellators and Essure, the issue of medical-device safety has reached Congress. Now, a number of bills aimed at improving safety are pending in Congress. […]
The Medical Device Safety Act seeks to remove this protection and allow patients to file lawsuits against manufacturers.
The bill has the support of consumer advocacy groups, including Consumers Union (the policy arm of Consumer Reports) and The National Center for Health Research (NCHR).
“If a patient dies from the use of a PMA-approved medical device, there is no accountability for that person’s surviving family,” Lisa McGiffert, director of Safe Patient Project, and Diana Zuckerman, president of NCHR, wrote in a letter to the Committee on Energy and Commerce. “H.R. 2164 merely allows states to determine how best to protect patients from unsafe medical devices, just as the law allows states to protect patients from unsafe prescription drugs.” […]
The journey has been emotionally moving for Amanda Rusmisell and her fellow advocates at Essure Problems. Even today, speaking about it brings her to tears.
“I’ve seen women from all backgrounds whose lives were ruined by Essure,” she said. “But I’ve had the opportunity to see women helping women. We’ve come together to form a grassroots organization, and we made it to Congress.”
Read the original article here.