In a shocking turn of events, information was recently uncovered and released to the public today that proves Bayer, owner of the “permanent” birth control device Essure, knew of the risk of unwanted pregnancies after implantation of its device. Talk about getting caught with your hand in the cookie jar! That the Big Pharma giant knew is not shocking; that someone was able to uncover the information is the shocker. As many of us who advocate for the removal of this dangerous product have long believed, Bayer lied about Essure pregnancy risks.
According to a press release issued today, a law firm in New Orleans, Unglesby + Williams, found new evidence that Bayer knew the number of unwanted pregnancies in Essure patients that it reported to the FDA was roughly one-third of those that actually occurred!
After a great deal of pressure from the grassroots movement, Essure Problems, along with Congressman Mike Fitzpatrick (R-PA) and other activists, the FDA held an advisory committee hearing on September 24, 2015. The purpose of the meeting was to discuss Essure’s safety and efficacy. Prior to the September hearing, the FDA thought the number was 631 unwanted pregnancies.
“FDA has received 631 reports of pregnancies in patients with Essure. Of these, 150 were reported to result in a live birth; 204 did not indicate whether the pregnancy resulted in a live birth or pregnancy loss; and 294 resulted in pregnancy loss.” ~ FDA website. Click FDA Hearing Information for the full document and see page 4.
At that hearing, the FDA told everyone present that Bayer reported 748 unwanted pregnancies in women with the Essure device.
“The table shows 748 pregnancy reports received directly from the Sponsor, recorded in the FDA MAUDE database, and reported in the scientific literature. The time range is 2001 through end of 2010.” ~ Page 90, Official transcript of the September hearing. Click OBGYN 09-24-15.FINAL Transcript for the full document (warning: 326 pages).
Dr. Edio Zampaglione, Vice President for U.S Medical Affairs for Women’s Healthcare and Neurology at Bayer, held firm to the tired rhetoric that Essure’s efficacy rate is great than 99% and “only a small number of pregnancies occur.” Despite knowing the truth, Dr. Zampaglione didn’t bother to correct the FDA’s report with the truth.
Enter Unglesby + Williams and the independent researcher they hired, Madris Tomes. The team found one internal Bayer report that said the company searched its database in March 2015 and found 2,028 reports of pregnancy from Essure patients.
Lance Unglesby, partner with Unglesby + Williams said, “Our findings underscore a sobering fact: Bayer has known Essure was not as effective as it continues to claim. Even though Bayer had counted more than 2,000 cases of reported pregnancies in women while using its birth control device, somehow only one third of those reports made it to the FDA.”
What happened to the other reports? The number of reported pregnancies in all other reports reviewed by Ms. Tomes was redacted by Bayer. This one report was “buried among all of the other patient complaints.”
Somehow, the company missed this one report and now the truth comes out. The truth that Bayer conducted an internal database search on March 10, 2015, a little over six months before the September hearing and found 2,028 pregnancies.
“In this particular case a search in the database was performed on 10-mar-2015 for the following meddra preferred terms: device dislocation: the analysis in the global safety database revealed (b)(4) cases. Device breakage: the analysis in the global safety database revealed (b)(4) cases. Pregnancy with contraceptive device: the analysis in the global safety database revealed 2028.” ~ Pregnancy Report, page 2. Click Pregnancy Report for the full document.
According to Jason Williams, partner with Unglesby + Williams, “These numbers clearly show that Bayer has not been transparent with the FDA or the public. We expect to expose more of this type of wrongdoing and will be filing lawsuits in St. Louis on behalf of 1,000 women hurt by Essure in the weeks to come.”
Added Mr. Unglesby, “It’s time we hold Bayer and big pharmaceutical companies accountable for faulty products, lax reporting methods, and in some cases systemic cover-ups and misleading information. Patients put their trust in these companies, and they deserve justice when that trust is broken—and people are seriously injured.”
The results of the FDA’s hearing were disappointing to say the least. In March 2016, the agency said it was now requiring a “black box warning” on Essure. Such warnings are used only for “serious or life-threatening risks.”
Hope is not lost, though. In fact, it is alive and well. Remember Congressman Fitzpatrick? In November 2015, he introduced the E-Free Act (H.R. 3920), which would remove Essure from the market and strip Bayer of the pre-market approval (PMA) status that has been shielding the company from legal action. There have been challenges to the PMA in the courts and, for five injured women, suits have been allowed to proceed.
Since that decision, other suits have been filed. One by Eric Holland of the Holland Law Firm (in which Unglesby + Williams is listed as “anticipated pro hac vice” (for or on this occasion only) and one by Holly Ennis of Ennis & Ennis, P.A. Soon as per Mr. Williams’ statement, there will be another suit.
It is my fondest wish that these suits, now with the extra punch of this newly-discovered evidence, will finally bring justice to those named plaintiffs and open the gate for the tens of thousands of women injured by Essure to get justice, too.