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Insufficient data may have been used by the Food and Drug Administration to approve Essure for the market. That’s the news from Northwestern University, where researchers have studied OB-GYN devices approved by the FDA over the last 15 years. The results of the study? Essure, among others, was sent to market based on flawed and incomplete data.

The study found that Essure was approved on short-term studies in incomplete post-market follow up. Not enough research was done on the long-term effects of the medical device, nor were there any studies conducted about Essure once it was released on the market. More than 25,000 women have experienced extreme symptoms related to their Essure devices. There are as many as 26 deaths associated with the birth control device.

Earlier this month, Representative Mike Fitzpatrick launched medical device and FDA reform bills. He, along with other lawmakers, seek to reform the way the FDA approves devices like Essure. Supporters of the bill hope the FDA will strengthen their review practices and have increased accountability for dangerous products that slip past them and onto the market.

Essure Injury Lawsuits

The Law Offices of Richard J. Serpe, PC are currently investigating potential injury claims for anyone who has suffered from complications or has been seriously injured by an Essure permanent birth control device. If you’d like to discuss your situation, contact us to set up a free consultation 877-544-5323.

Talcum Powder LawsuitsEssure victims have found a new ally in their fight to get the device removed from the market. Pennsylvania Congressman Michael Fitzpatrick has made it his mission to get the FDA to look closer into the defective medical device, particularly after some suspicious errors were found in adverse event reports.

When a doctor discovers a problem with a medical device, he or she reports it to the FDA using codes provided by the maker of the device. These codes can give regulators insight into the kinds of problems that are frequently occurring in patients around the country. But when the codes are not reliable, they fail to do the job they’re designed to: alert the FDA to potential dangers.

That’s the story with Essure, a permanent birth control device that’s caused thousands of women pain and suffering. It was recently discovered that many of the Essure adverse event reports submitted by physicians failed to include the reporter’s occupation, due to an error in the coding. This meant that countless problems reported were not associated with actual doctors – and likely taken less seriously because of this.

While errors are bound to happen from time to time, some believe there may be a more sinister explanation behind the mistake. Congressman Fitzpatrick penned a letter to the FDA addressing his concerns. In the letter, he pointed out an odd coincidence:

“This coding changed dramatically in July of 2015,” Fitzpatrick wrote. “I find this extremely concerning, given the fact that on July 17th, 2015, the FDA announced it was reviewing the safety and effectiveness of the Essure device.”

Thousands of Essure users have experienced chronic pain, allergic reactions and even punctured tissue. Many of the women affected have filed lawsuits against the maker of Essure, Bayer.

Essure Injury Lawsuits

The Law Offices of Richard J. Serpe, PC are currently investigating potential injury claims for anyone who has suffered from complications or has been seriously injured by an Essure permanent birth control device. If you’d like to discuss your situation, contact us to set up a free consultation 877-544-5323.

 

As consumers, we rely on federal agencies to protect us against hazardous products. When that responsibility is not taken seriously, the FDA puts millions of people at risk. That’s why the latest Essure news is such a relief for women across the country.

The Food and Drug Administration has begun an investigation into the controversial birth control device Essure. This news comes after thousands of women have voiced their complaints about the product.

Many of these women have turned to social media to lament their troubles to others with similar negative reactions to Essure. Some report chronic pain, while others have needed surgery to remove the device from where it became lodged in their organs.

The investigation launched by the FDA will require additional clinical testing of Essure, as well as a warning label on the box. Doctors will now also be required to go through a checklist of questions with their patients about whether the device is right for them. More than 750,000 of these devices have been sold worldwide.

The makers of Essure, Bayer, stand behind their product. They’ve acknowledged the problems that some women have experienced, but are dismissive in their official statement. “We are particularly concerned about statements that may be creating an atmosphere of unfounded fear,” the company said.

Essure Injury Lawsuits

The Law Offices of Richard J. Serpe, PC are currently investigating potential injury claims for anyone who has suffered from complications or has been seriously injured by an Essure permanent birth control device. If you’d like to discuss your situation, contact us to set up a free consultation 877-544-5323.

A group of women are taking their complaints straight to Washington, D.C. after their Essure implants caused undue pain and suffering.

A new Congressional act would require the Food and Drug Administration to pull Essure’s status. Pennsylvania Representative Mike Fitzpatrick is the man behind the “e-free” act, which would dramatically change Essure’s role on the market. Fitzpatrick and the victims he’s helping won’t rest until the device is removed for the market or made safe for all users.

Essure has been the center of much controversy recently. The birth control device was designed to permanently prevent pregnancy, but without the unnecessary risks of a surgical procedure like a tubal ligation. Unfortunately, however, women experienced painful side effects they weren’t warned about in advance.

Joint pain, debilitating headaches, allergic reactions to the nickel that the device is made from were just a few of the laundry list of issues Essure users experienced.

Side effects can be expected from most medical devices and procedures. The difference with Essure is that the women who received the implant had no idea of the potential pain and suffering they would face. So far, their complaints have fell off the deaf ears of the FDA and of the makers of Essure. Perhaps with Congressman Fitzpatrick on their side, these victims will finally find justice.

Essure Injury Lawsuits

The Law Offices of Richard J. Serpe, PC are currently investigating potential injury claims for anyone who has suffered from complications or has been seriously injured by an Essure permanent birth control device. If you’d like to discuss your situation, contact us to set up a free consultation 877-544-5323.