FDA downplayed fetal deaths linked to Bayer's Essure contraceptive: Analyst
|Essure--Screenshot courtesy of Bayer|
Bayer has been dealing with backlash over its Essure contraceptive implant, with some critics saying that the device caused serious problems in pregnant women. The FDA has found at least 5 fetal deaths in women who used the implant, but one analyst is pegging this number much higher.
Madris Tomes, founder and chief executive of data analysis firm Device Events, combed through thousands of side effect reports on the FDA's website and found 303 fetal deaths linked to Essure, Reuters reports. Women became pregnant after getting the implant, which consists of two metal coils that are inserted into the fallopian tubes.
Tomes said that the difference between her count and the FDA's has to do with the way the agency searches adverse event reports. The agency looks for broad headings rather than searching through detailed texts of complaints, Tomes said.
"When adverse events go to the FDA, 'death,' 'injury' or 'malfunction' are the boxes you check. My system searches the (fuller) narrative," Tomes told Reuters, and uses keywords such as 'fetal death,' 'stillbirth,' 'stillborn' and miscarriage' to turn up potential issues.
Bayer is standing by its device. "Irrespective of the type of birth control a woman uses, when pregnancies do occur, there can be complications. It would be irresponsible to suggest that Essure causes fetal deaths when, after an unsuccessful Essure procedure, an undesired pregnancy cannot be carried to term," a Bayer spokeswoman told the news outlet.
Tomes' findings only add fuel to the fire as critics lambaste the device's safety. The FDA has received thousands of complaints about Essure since it was approved in November 2002. And most of those complaints come from after Bayer acquired the device through its $1.1 billion deal for Conceptus in 2013. About 750,000 women have used Essure, and 70% of them are in the U.S.
In response to mounting pushback, the FDA said in 2014 that it would investigate the product. In September 2015, the agency held an advisory meeting where dozens of women urged regulators to withdraw Essure, saying that too little is known about its potential risks.
Lawmakers are also weighing in on the debate. In October, Rep. Mike Fitzpatrick (R-PA) introduced a bill to ban Essure. Earlier this week, Fitzpatrick sent the FDA a copy of Tomes' report, asking the agency to look at the "immense discrepancy" in numbers, Reuters reports.
The FDA declined to comment to the news outlet about Tomes' numbers. But the agency said that it would review the findings and respond to Fitzpatrick, FDA spokeswoman Deborah Kotz said.
Meanwhile, the agency is considering beefing up its oversight of the devices. The FDA this month is slated to decide whether or not to restrict the device's use, change its label or recommend additional clinical trials.
- read the Reuters story
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