Nowadays Erin Brockovich is fighting another cause against women discrimination and health risks against a dangerous birth control method: the infamous Essure. Erin Brockovich’ figure rose to success as the single brave woman who took the fight against American corporations alone and was able to win. Her popularity was immortalized by her famous portrayal played by Julia Robert’s Hollywood movie.
The risks of Essure complications and side effects
Essure is a permanent birth control method used to sterilize women without surgical interventions. The device consists of two metal coils inserted into the fallopian tubes through the vagina. As soon as scar tissue is formed around the coils, both the fallopian tubes get blocked, and sperm cells are prevented from reaching the eggs. It is a less invasive method of contraception than surgical laparoscopic tubal ligation that eliminates the need for other birth control forms without exerting any effect on the menstrual cycle. Conceptus Inc., the subsidiary of Bayer AG, who manufactures this medical device, always portrayed it as safe and efficient. The Food and Drugs Administration (FDA) granted its approval to the birth control device back in 2002 through the premarket approval process.
However, Ms. Brockovich, as well as thousands of women who tried this device, seem to have an entirely different opinion about Essure’s safety. In a past interview with BBC, Erin Brockovich explained how Essure is dangerous by showing how many women got their uterus or colon perforated. The medical device is in fact linked with an alarmingly high number of life-threatening complications including device migration and organ perforation. In some instances, doctors had to perform entire body scans on women who were implanted with it, to find where the broken fragment of the device logged inside their bodies, exposing them to dangerous irradiation. In some instances, the “permanent birth control method” didn’t work as intended, and women ended up getting pregnant nonetheless. A woman “couldn’t have [the coil] removed” explained Erin, “and in the 25th week of the pregnancy, it broke and migrated, perforating the amniotic fluid.” Sadly, the child didn’t make it.
Bayer Discrimination against Women
Bayer AG sticks to the purported safety and effectiveness of its product and defends it against the newly born “E-sisters”, the women who suffered the serious consequences of this device’s side effects. Dr. Edio Zampaglione, Bayer’s US medical director, explained that his company empathizes with the many women who everyday call for an Essure attorney to ask for compensation. He talked about “a lot of emotions involved” and about the importance of “science […] guiding our understanding”. He speaks like all the women got injured and harmed by the adverse reactions associated with this device are just a bunch of hyperemotional, irrational beings.
What he was talking about is just discrimination against women, instead.
Bayer claimed that 750,000 women worldwide received a safe device implantation without suffering from any complication whatsoever, with a 99.83% effectiveness if the implant procedure was performed correctly. Within two days from the procedure, women can revert to normal activity, according to the FDA. Since the device was approved back in November 2002, FDA received a total of 943 reports of adverse events, mainly complaining about pelvic and back pain, cramps and fatigue. However, after Ms. Brockovich raised the awareness about the Essure dangers in October 2013, the number of complaints grew up to a total of 5093 total reports, including 6 cases of death. In just a few years, the Facebook group called Essure Problems where many women shared their experiences with the so-called “E-Hell” reached a total of 24.745 total members.
Kim Myers, a woman who underwent the procedure to get the device implanted back in 2008, immediately started suffering the most dreaded complications. The pain was excruciating that she had to stop riding horses competitively, and even her marriage was destroyed as a consequence.
“I have never in my life felt discriminated against like I have with this whole thing with Essure,” explained Ms. Myers, who was considered just a “silly […] hormonal […] little woman” by the doctor who pressured her to receive the implant. Bayer attorneys discriminated women so much that they’re hiding behind US federal pre-emptive laws to avoid “frivolous” Essure lawsuits from consumer right advocates such as Erin Brockovich.
” Bayer can’t just turn their head and go ‘these 8,000 women don’t matter’,” said Ms. Brockovich, “One’s too many. Eight thousand women? You cannot disregard that voice collectively. There is something wrong with the product.”
Could the FDA issue an Essure recall in 2017?
The dangers associated with the use of Essure are anything but frivolous, indeed. FDA publicly admitted that a proper evaluation of the long-term safety of this device was never completed and that on September 24, 2015, a reevaluation of its safety profile will be conducted. Although a first investigation issued in February 2016 did not warrant for a recall of this product, the number of litigations filed against Bayer and the number of adverse reaction reports never stopped growing.
In the meanwhile, Ms. Brockovich asked many women to share their stories and experiences, and never lose faith in the chance of receiving compensation from the pharmaceutical company. Although she had no formal legal education when she fought in the famous case against Pacific Gas and Electric Company of California, Erin Brockovich was still a central figure that determined the winning outcome of that class action.
Article written by: Dr. Claudio Butticè, Pharm.D.