Parker Waichman LLP

Women Await FDA Decision on Controversial Essure Permanent Birth Control

FDA is expected to announce the results of its investigation   FDA Announced The Results Of Its Investigation Into Essure. The Food and Drug Administration (FDA) is expected to announce the results of its investigation into Essure, a permanent form of birth control. Thousands of women are advocating that the device is dangerous and should be […]

FDA is expected to announce the results of its investigation

Essure Permanent Birth Control

 

FDA Announced The Results Of Its Investigation Into Essure. The Food and Drug Administration (FDA) is expected to announce the results of its investigation into Essure, a permanent form of birth control. Thousands of women are advocating that the device is dangerous and should be pulled from the market.

Amanda Dykeman of Coal Valley, Illinois is one of those calling for Essure’s removal from the market, according to television station KWQC. Dykeman says she experienced life-changing side effects with the device. “My hair was falling out, I had bloating out to where I looked 8 months pregnant, I was tired all the time,” Dykeman said.

‘Essure’ is a permanent form of birth control, marketed as a non-surgical alternative to standard laparoscopic sterilization surgery, which is done with small incisions. The ‘Essure’ device consists of a small pair of metal coils that are inserted into the fallopian tubes to create scar tissue that blocks the tubes and prevents pregnancy. ‘Essure’ can be inserted in a procedure in a doctor’s office.

But women implanted with Essure have reported complications including pelvic pain, painful sex, organ perforation, device migration, metal allergies, unplanned pregnancies, and ectopic pregnancies, which can be life threatening if not detected early. “Just over the last two years we’ve tracked over 4,000 device removal surgeries,” Dykeman said.

Woman Claimed Adverse Effects From Essure

Enough women came forward claiming adverse effects from ‘Essure’ that in 2015 the FDA opened an investigation. In September 2015 the agency convened the Obstetrics and Gynecology Devices Panel to gather scientific and clinical information about ‘Essure’ and to hear women’s accounts of their experiences with the device.

Members of the online group ‘Essure’ Problems spoke to the panel. Dykeman, an administrator for Essure Problems, presented evidence that Bayer falsified clinical trial records to get the device approved. Original participants in the Essure trials came forward and said their responses to questions about complications were falsified.

Dykeman has been an advocate for removing Essure from the market. She says every day new women come forward to share their stories. Dykeman worries that the FDA will not take serious action on ‘Essure’, but will give Bayer, Essure’s manufacturer, “a slap on the wrist,” according to KWQC.

If the FDA does not withdraw Essure’s market approval, the group plans to continue to push for change. The group has already approached Congress with their concerns and Rep. Mike Fitzpatrick of Pennsylvania introduced the E-Free Act, legislation that would require the FDA to withdraw ‘Essure’ from the market.

Though Bayer maintains that a decade of use has demonstrated that ‘Essure’ is safe and effective, some doctors have stopped offering the device to patients until the FDA’s findings are released. “We need to re-evaluate what we can do to make something work in the future,” Dykeman said, KWQC reports.

Need Legal Help Regarding Essure Permanent Birth Control Lawsuit

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).

Our essure birth control lawsuit attorneys are here to help you when you need it the most.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Working with Joanne and Jillian, these two were on top of things from the get go. I had never been through this type of situation before, so they guided me through the process and explained everything that was going on in a way that I could understand it. Definitely recommend them to anyone in need.
William Pilc
5 years ago
5 Star Reviews 150
Michele Josama Has been an Amazing Help, I appreciate all she has done!! Her customers service is 100%.
Angee Hammond
4 years ago
5 Star Reviews 150
I want to start off with saying thank you to the entire firm for taking my case but I especially want to thank Benita Rollis. She kept me updated throughout this whole process that was completely new to me and always answered any concerns I had. Parker Waichman LLP you have a gem in Benita Rollis and I will definitely recommend your law firm. Thank you.
C Torres
3 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038