After thousands of complaints, FDA will consider banning dangerous Essure sterilization device
April 1, 2015 (LifeSiteNews.com) -- After thousands of injuries and several deaths of women implanted with the Essure sterilization device – touted as a safer, less invasive alternative to surgical tubal ligation – the Food and Drug Administration (FDA) is finally taking action.
In response to a petition signed by more than 2,100 women urging the agency to remove Essure from the U.S. market, the FDA announced last week that it will launch an investigation into the allegations made by the petition’s signers.
The Essure device consists of a pair of metal coils designed to be implanted in a woman’s fallopian tubes, where they induce sterility by irritating the sensitive lining, causing a buildup of scar tissue that blocks passage of sperm and ova between the ovaries and the womb. The device was given conditional pre-market approval (PMA) by the FDA in 2002, a process that grants the manufacturer lifetime immunity from lawsuits related to the device, as long as the company upholds the terms of the approval.
The FDA says this practice – known as “preemption” – is fair because the scrutiny manufacturers must undergo to qualify for PMA is so rigorous that any significant risks would be caught long before the device ever hit the market. But the petitioners say Essure’s PMA process was unusually rushed, and ultimately rendered invalid by the numerous lies and cover-ups its manufacturer used to fool the FDA into thinking the device was safe.
According to the petitioners, Essure’s original manufacturers, Conceptus, Inc., falsified data during clinical trials in order to hide adverse reactions and injuries caused by the device. Multiple cases of uterine perforation – caused by coils drifting out of place and resulting in hysterectomies for the victims – were allegedly completely hidden from the FDA. Women who reported severe pain had their medical records altered to say that they were happy with the device and had no trouble at all. Later, in the interest of boosting sales, the company would successfully convince the FDA to allow the removal of a safety notice warning women with nickel allergies – up to 15 percent of the female population – not to use the device, which is made of a nickel-titanium alloy.
Conceptus is also accused of violating not only the terms of the PMA, but federal law by using unapproved materials to manufacture the Essure devices at unlicensed facilities, and by failing to notify the government of more than 16,000 complaints from women injured by the device, as well as several deaths.
Pharmaceutical giant Bayer bought out Conceptus in 2013, but according to the petitioners, the lies continued. The petition accuses Bayer of knowingly misleading its customers by promoting Essure as safe and “worry-free” while concealing numerous life-threatening injuries suffered by women during Conceptus’ clinical trials. It also accuses Bayer of exaggerating the device’s effectiveness, claiming that “no pregnancy can occur” with Essure even though the company’s own records show that between 1997 and 2005, 64 women became pregnant after having the device implanted. Today, the total number of Essure pregnancies stands at more than 700 – including former celebrity spokeswoman Picabo Street, who lost her endorsement contract after becoming pregnant.
Essure pregnancies are dangerous to both baby and mother, and doctors often urge women who become pregnant after Essure implantation to abort. For women who choose to give their unplanned babies a chance at life, the journey they face is fraught with peril. Adverse events reported by Essure moms include miscarriage, ectopic pregnancies, premature birth due to membranes ruptured by loose coils, and birth defects caused by nickel poisoning.
“Full disclosure is a necessity when deciding to implant a foreign device into one’s body,” wrote the petition’s authors. “Bayer should not be able to market and sell a medical device that was approved by the FDA on fraudulent results of its clinical trial and altered medical records. This puts the public in grave danger.”
“How can the public expect Essure to be safe and effective when … there is evidence of fraud in the preapproval process; … adverse events are not being reported; … complaints are not being considered in Essure’s risk analysis; … CAPA activities are not being documented; … Essure’s risk analysis is incomplete; … quality assurance forms, used for tracking non-conforming product, were not used; and … Essure violated its own PMA Order and federal law?” the signers asked.
The petitioners are asking that the FDA revoke Bayer’s PMA, opening the door for victims of complications from Essure to sue the company. Additionally, they want the FDA to order the company to publicly disclose all the adverse events it hid from the government and consumers. In the meantime, they say, the FDA should either recall Essure or require a black box warning on all packaging notifying consumers of the fraudulent safety data until Bayer carries out a new round of studies, this time factual and non-doctored.
The FDA said it has referred the case to its “Office of Compliance,” which will “investigate the complaint” and “pursue actions as deemed necessary.”