Essure Lawyers

Essure Lawsuit: FDA Investigates Essure Sterilization Device

Essure is a permanent, sterilization device implanted in the Fallopian tubes. Marketed as the only permanent birth control available for implant via a nonsurgical procedure, the device, which was developed by Conceptus Inc, a subsidiary of Bayer AG, received FDA approval for use as permanent birth control in 2002. Call today for a consultation with our Essure Lawyers.

After collecting thousands of reports of medical complications from women across the United States, the FDA has launched an investigation into allegations that Bayer misled the public and federal regulators with its statements about the safety and efficacy of Essure. There have also been allegations that the company falsified or altered medical records of the patients involved in the clinical trials, and that Bayer used defective materials during the manufacturing process. These materials include low-quality metals that could corrode and lead to nickel allergies and metal poisoning.

Side effects reported by Essure recipients include:

  • Extreme pelvic pain
  • Cramping in the pelvic region not associated with menstruation
  • Menstrual irregularities
  • Severe back pain
  • Serious, inexplicable fatigue
  • Weight gain or weight fluctuation
  • Headaches
  • Device migration or breakage, which can result in organ perforation
  • Heavy, irregular bleeding not associated with menstruation
  • Painful intercourse
  • Painful menstruation
  • Adverse reactions due to nickel allergy
  • Depression or suicidal thoughts

In many cases, side effects were so severe that Essure had to be surgically removed.

Bayer claims that Essure has a “well-documented benefit-risk profile,” and that the device has been implanted successfully in 750,000 female patients. The pharmaceutical manufacturer claims that the devices are 99% effective in preventing pregnancy in patients, and the risks of harm are “rare.”
A study published in the British Medical Journal (BMJ) on October 13, 2015 concluded that Essure was not more effective at preventing pregnancy than a similar laparoscopic procedure. However, despite the fact that Essure is implanted during a non-surgical procedure, Essure had a “10-fold higher risk of undergoing reoperation” compared to patients who underwent a laparoscopic tubal ligation procedure. Ironic given that Bayer markets the initial nonsurgical implant as advantageous.

Defective Device Claims

A number of personal injury claims have been filed against Bayer accusing the company of providing misleading information and design/manufacturing defects, including:

  • Failing to report, and actively concealing, perforations
  • The use of non-conforming materials in the manufacture of Essure
  • Manufacturing Essure at an unlicensed facility
  • Falsifying medical data.

Plaintiffs allege that Bayer “was concealing adverse reactions, not using conforming material approved by the FDA, not using sterile cages, operating out of an unlicensed facility, and manufacturing medical devices without a license to do the same.” Many plaintiffs argue that the class action protection afforded Essure by the premarket approval process should be removed.

Strom Law Firm Investigates Essure Injury Claims

If you live in South Carolina or Georgia, and you or a loved one suffered complications after implantation of an Essure device, contact the Strom Law Firm for a free consultation. Our firm is now investigating claims against Bayer AG, so contact us today.

How this works

Step 1 - Welcome
In this step, you'll experience a warm welcome as you enter the Strom Law Firm.
1
Step 2 - Initial Meeting
You'll meet with professionals. They will go through the facts of your case, explain the entire process.
2
Step 3 - Preparations
We builds your case by interviewing witnesses, conducting legal research, drafting pleadings, and hiring experts.
3
Step 4 - Trial
You'll learn that the firm is trial-ready. They've been preparing since day one and will guide you through the process.
4
Step 5 - Resolution
your case concludes with the firm hoping for a positive outcome. They assure enduring friendships and a commitment to being there for you, regardless of future legal needs.
5
No obligations & no credit card required

STROM LAW IS...

years combined
legal experience
0 +
awards &
accredetations
0 +
Founded
in
0
years
in business
0

What Our Clients Say

They truly care
Mrs Vallery, who answered the phone took more care and attention to detail than any other law office, that I have called, in 2 years+. She diligently took notes to give to the lawyers and cared about my situation and let me actually tell everything without cutting me short. Out of over 100 law offices, this is rare treatment. Care. Consideration. That means more than anything going through this…
Anonymous
google-logo
Professional Representation, Satisfying Legal Outcome!
My wife and I retained Bakari Sellers to represent our son in a case in Richland County. We found Mr. Sellers, his assistant Stephanie, and the rest of the staff at Strom, extremely courteous and professional. We really appreciated Mr. Sellers’ straightforward and honest approach. We believe this is a very competent law firm, and are satisfied with the legal outcome they achieved. We would highly recommend them!
Bryan B.
google-logo
Exceptional Legal Team After Our Car Accident!
We retained Atty Jessica Fickling to help us after a terrible car accident. She and her paralegal Mallory were wonderful! Professional, skilled, savvy – we couldn’t have asked for a better legal team. Many thanks!!
Jocelyn C.
google-logo
Strom Law Firm's Consistent Excellence
I have been a client with The Strom Law Firm for thirty years and have been incredibly blessed to have the assurance that they will do everything possible to provide excellent service to my needs. Ally Benevento is exceptional and represents the firm in a professional manner.
Timothy O.
google-logo
From Self-Representation to Victory in SSDI Case!
My experience with Mario and his staff was outstanding. When everyone said to give up my case with SSDI and after being poorly represented and losing. I had to file my own appeals and represent myself. I literally called every attorney in the book. Then I called Mario cold – I expected one more no! Well, this gentleman took my case and won. He knows the law and cares a lot. I am proud to call him my friend. If you need a professional to help you, call these guys.
Robert L.
google-logo
A Pleasure to Work With, Outstanding Case Outcome!
Thanks Olivia, It was a pleasure working with you. You were well prepared and presented our case in a very professional manner. I could not have ask for a better outcome. Working with everyone at the Strom Law Firm has always been a pleasure and I will be happy to recommend your Law Firm to anyone.
Nancy G.
google-logo
A Lifesaver in the Courtroom, Ensuring Freedom with A1 Professionalism
Needed a lifesaver. I had gotten myself into a bad situation and the possibility of going to prison. Through the diligence and hard work done by attorney Alley B., I was able to walk out of that courtroom a free man. No tricks just hard down attorney work. She was an A1 professional and knew every inch of the Law pertaining to my case. For that, I am forever grateful.
Anonymous
google-logo
A Winning Team at Strom Law Firm!
John Alphin was great. We basically worked together for 22 months. Bakari Sellers was also on the team and together those 2 guys were fabulous. Won the case and I’m still a client of Strom law firm. Thank you and awesome law firm.
Steve T.
google-logo
Excellence in Action for Workman's Comp Case!
Strom Law Firm was really great and professional. I had a great experience with Mario as my attorney and his paralegal, Brian. These two are amazing, they worked very hard on my husband’s workman’s comp case and we were very pleased with the services and results 👍. Brian was so prompt at returning phone calls and getting things ready for the case. I strongly recommend this firm for any of your legal matters. If I had to use you guys again, I would be happy to do so.
Mary W.
google-logo
Mastering Complex Legal Issues with Care and Compassion
Mario Pacella at Strom Law Firm LLC in Brunswick, Georgia, is a masterful, no-nonsense lawyer. His caring and compassionate approach, along with prompt responsiveness, sets him apart. Mario and the firm exhibit exceptional professionalism and attention to detail, emphasizing genuine care for every client.
L. Gilder
google-logo
No obligations & no credit card required

Contact Us For A Free Case Evaluation

  • This field is for validation purposes and should be left unchanged.

No obligations & no credit card required

*A consultation fee applies to employment matters