A German-based pharmaceutical company is receiving flak for allegedly promoting the sales of a dangerous birth control device. The US Food and Drug Administration wasn't spared from the people's ire, too, as several sectors, spearheaded by congressman Mike Fitzpatrick, have accused the agency of a grand cover up.
Citing a non-government investigation, Fitzpatrick revealed that the contraceptive tool, known as Essure, has been responsible for the miscarriages of 303 women. The figure is a far cry from what the FDA is reporting. According to the agency's official website via KSHB there have only been five fetal deaths that can be traced back to the use of Essure.
Bayer HealthCare, the pharmaceutical company in question, explained that Essure is a quick 10-minute procedure that can be done at the nearest doctor's office. The process involves thin metal coils being inserted into the fallopian tubes to obstruct fertilization. Bayer HealthCare even boasts that women will be able to walk and do their normal activities just two days after the operation.
Fitzpatrick, meanwhile, was not impressed with the revolutionary birth control device. The Republican representative said that aside from fetal deaths, the procedure also carried debilitating side-effects to the mother including weight gain, severe bleeding, excruciating pelvic pains and death.
A panel from the FDA Obstetrics and Gynecology Devices stated in September 2015 that there hasn't been any conclusive evidence that supports the safety of Essure. The group reminded doctors and patients alike to limit the use of the said birth-control device whenever possible, as per Modern Healthcare.
Apparently, Bayer HealthCare and Essure manufacturers Conceptus Inc. did not heed the warning. Fitzpatrick also announced this week that he had received a copy of a complaint against the two companies filed in the U.S. District Court in California.
The complaint alleged that Bayer Healthcare and Conceptus Inc. had given away free medical equipment and illegal financial incentives to providers in order to increase the use of Essure. Pharma Live indicated that the "unsafe" operation has taken a large chunk off the US government's budget.
To pull Essure permanently off the shelves, Fitzpatrick is set to propose the E-Free Act. The legislation intends to ban the selling and use of the controversial thin metal coils. The directive will be enforced by the FDA once the bill ultimately becomes a law.
