BCA is investigating lawsuits over Essure as this birth control drugs have been tied to an increased risk of dangerous side effects. Essure is manufactured by Bayer HealthCare as a permanent form of birth control. Essure is a non surgical permanent form of birth control, which has two flexible coils that are inserted through the vagina. Essure Birth Control was approved by the FDA in 2002 via the FDA’s fast track system of review. The Essure Birth Control lawsuits argue that the Essure Birth Control devices were not properly tested for dangerous side effects. The FDA has received at least 4,500 adverse event reports since Essure Birth Control was approved. Some of the reported side effects of Essure Birth Control include:
- allergic reactions
- excessive bleeding
- organ perforation
- pelvic pain
- ectopic pregnancy
Essure FDA Recall
Bayer purchased Essure from Conceptus, Inc, in 2013. There has been reports that the Essure device has a tendency to migrate which causes serious issues and could result in multiple surgeries to be performed to correct the device. There have been reports that woman have suffered from blood clots, infection, pain and depression. In June of 2015, the FDA added risk information to it’s website related to Essure. They held a public meeting at the Obstetrics and Gynecology Devices Panel to discuss the possibly dangerous side effects of Essure. Click here to review the FDA Essure information directly from the FDA. In 2013 the FDA said it had conducted a review and found that there were 943 adverse event reports. Now in 2015, the FDA states that the number of Essure adverse event reports has climbed to 5,093. Bayer HealthCare said it will be participating in the FDA’s next public meeting on Essure this fall.
On October 9th, US Rep. Rosa DeLauro sent a letter to FDA asking for Essure to be recalled. Delauro raised many issues in her Essure FDA recall letter, saying that the benefits don’t outway the risks. She also cited a Yale study which concluded that Essure is less effective in preventing pregnancy thatn Tubal Ligation. In addition, DeLauro asked why patients were only allowed to speak at the public portion of the meeting. At that meeting, there were experts who were excluded from presenting at the FDA Essure Meeting. Those experts had to speak from the audience rather that presenting data with the other experts. Click here to view the full letter which US Rep. Rosa DeLauro sent asking the FDA to recall Essure.
First Essure Lawsuit Filed
The first Essure Lawsuit was filed in Philadelphia civil court against Bayer in July of last year. That Essure lawsuit states that Bayer mislead woman about the dangers of Essure and side effects. The woman who filed this Essure lawsuit also states that Bayer failed to adequately train implanting physician. Famous advocate Erin Brockovich has also petitioned to have Essure removed from market as she also questions the premarket approval of Essure. This Essure Birth Control Lawsuits claims that the coils of which Essure are make of fell out of the fallopian tubes which required 5 stays in the hospital. The lawyers in this particular Essure Birth Control Lawsuits are asking for $50,000 for both compensation and delay damages. Bayar has no comment on this Essure Birth Control Lawsuit.
If you are a loved one have suffered side effects caused by Essure, you may be entitled to compensation. BCA is a national law firm, which experience in complex medical and pharmaceutical lawsuits. Our pharmaceutical attorneys have represented thousands of clients against some of the largest drug manufacturers in the world, including GlaxoSmithKline, Merck, Pfizer, and Bayer. Our pharmaceutical team has the knowledge and skill necessary to go head-to-head against the largest drug manufacturers in the pharmaceutical industry.