Permanent birth control will include new health warnings
Updated On: Nov 13 2013 05:39:53 PM EST
Thousands of women who’ve been rallying against a permanent birth control device may finally be getting their point across.
Bayer owns the Essure device and announced changes to the patient information booklet.
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The information will now include two of the more major problems women have been experiencing with the device: pelvic pain and device migration.
As of late October, the FDA claimed it had received 943 adverse event reports in regards to Essure.
Over six hundred of those reports dealt with pain while 116 problems dealt with device migration.
Despite this change, women who blame Essure for their medical problems still do not have any legal recourse against Bayer because of a federal exemption.
The device was approved in 2002 as a class III device under the US Food and Drug Administration’s pre-market approval, PMA, process.
With PMA and class III status comes exemption from litigation as part of the Federal, Food Drug and Cosmetic Act or FFCA.
The FFDCA was actually passed in 1938 after 107 people died from a tonic elixir. The act allowed the FDA to demand evidence of public safety of new drugs among other provisions.
In 1976, the FFDCA was amended to applied safety and effectiveness safeguards to new devices, and specifically allowing Class III devices to receive legal exemption.
“If it was cleared by the FDA you have no case, and the US Supreme Court upheld that in 2008,” said Fermin Lopez, a civil trial attorney at Colling, Gilbert, Wright and Carter in Orlando.
Lopez said in the cases of medical devices you hope the government gets it right.
With Essure, the FDA said the device went through a stringent and rigorous process to get the PMA in the first place.
“The PMA process includes a scientific and regulatory review, including input from an outside panel of experts, to evaluate the safety and effectiveness of medical devices that pose the greatest risk to patients,” wrote an FDA spokesperson in an email.
In addition, the process includes a thorough review of what should be included in the labeling such as warnings and potential risks.
Women who have experienced problems with Essure, do not feel the FDA did enough before approving it.
“You just assume that when something is made available to the public and the doctors are educated on it, that it's safe... and it really isn't safe,” said Heather Hare, a Tampa area woman who had a hysterectomy to correct pain and problems she was experiencing after getting the device.
Hare is part of a group of over 3-thousand women that are part of the Essure Problems group on Facebook.
The group has been gaining attention of media around the country and their charge is being led by consumer advocate Erin Brockovich.
Both Bayer and the FDA contend that Essure has been used by some 750,000 women worldwide and there is not enough evidence to connect widespread problems directly to the device.
In an email, and FDA spokesperson said they take the reports seriously and encourage anyone having an issue with the device to report it through the MedWatch, the FDA Safety Information and Adverse Event Reporting program.
“ No form of birth control is 100 percent effective and scientific evidence reviewed by the FDA shows that Essure is a highly effective means of sterilization when used according to instructions,” said the spokesperson.