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FDA Orders Safety Study, Boxed Warning for Essure Permanent Contraceptive Device

Posted by Sarah Showard | Mar 22, 2016 | 0 Comments

FDA Orders Safety Study, Boxed Warning for Essure Permanent Contraceptive Device

In response to a surge of consumer complaints about the Essure permanent contraceptive device since October 2013, the FDA has now ordered its manufacturer, Bayer Healthcare Pharmaceuticals, to perform a postmarket safety study.

In addition, the FDA has proposed a box warning and a patient checklist highlighting the potential adverse events that could occur following implantation of the device, including persistent pain, perforation of the fallopian tubes or uterus, hypersensitivity reaction and device migration.

Essure was introduced in 2002 as an alternative to tubal ligation. The device is a small metal coil made of nickel and plastic fibers. Essure is inserted into each fallopian tube, resulting in inflammation and scarring that permanently seals the tube, permanently preventing pregnancy.

According to an FDA study, complaints about adverse events stemming from the use of Essure have quadrupled since late 2013. From 2002 until October 2013, the agency received 943 incident reports. Between October 2013 and May 2015, the FDA received 4,150 incident reports.

In addition, consumer advocacy groups calling for the removal of Essure from the market have popped up on social media. The Essure Problems Facebook page currently has 28,152 members.  

The FDA said Bayer must begin its postmarket safety study within 15 months. The study will follow 2,000 women implanted with the Essure device for at least three years. The proposed box warning says that doctors should inform patients about the potential adverse effects and ask patients to initial a checklist indicating they understand the risks.

Recently, Rep. Mike Fitzpatrick (R-PA) introduced legislation to recall Essure. "Frankly, I'd contend that the 25,000 women harmed by Essure are the postmarket study that FDA is ordering,” said Fitzpatrick. “It's been done. The evidence is all there: Tens of thousands of injured women and hundreds of fetal deaths."

If you have suffered injuries from an unsafe or defective medical product, the experienced medical device liability legal team at Showard Law Firm are here to help with compassionate, aggressive representation. Contact us today for your free consultation.

About the Author

Sarah Showard

Sarah Showard graduated from the University of Maryland in 1985, Magna Cum Laude with a Bachelor of Arts in English-Linguistics and a Certification in Womens Studies. She then graduated from New York University School of Law in 1988. Sarah began practice initially as an insurance defense attorne...

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