A federal judge this week issued a ruling that pharmaceutical giant Bayer will have to face many of the growing lawsuits alleging its permanent birth control implant Essure caused serious patient side effects.
The decision comes in the wake of other significant Essure news: a recent study showed the FDA had underestimated the number of fetal deaths linked to the devices; and the FDA’s response of ordering new Essure clinical trials and a black box Essure warning label.
Essure Side Effects Increase In Recent Years
Essure is a type of permanent birth control that is implanted into the fallopian tubes. Originally developed by Conceptus and approved by the FDA in 2002, it has been sold by Bayer since 2013.
So far, more than 750,000 women have received Essure implants. Until 2011, the FDA only received around 100 complaints. However, since that time, they’ve received over 5,000.
The Essure side effects reported to the FDA range from pain in the abdomen and pelvis to depression and hair loss. Some experts suspect these might be caused by metallic allergic reactions to the nickel used in the product.
Essure Maker May Have Concealed Data
Before approving Essure in 2002, the FDA reviewed testing results from around 600 women. However, the Journal of Minimally Invasive Gynecology recently reported that only 366 of the original clinical trial subjects were recorded for the entire 5-year period.
Also, many of the clinical trial participants have come forward since that time to reveal that doctors conducting the study ignored their pain complaints.
In May of 2015, Bayer claimed that only 7% of Essure users had experienced pain. However, the National Center for Health Research published a study of over 1,000 women using Essure, finding that over 85% had experienced significant pelvic or abdominal pain.
Essure Linked to Fetal Death
In February, a report indicated the birth control device may be linked to far more fetal deaths than previously believed.
Official FDA records indicate the agency has only received reports of 5 fetal deaths in women who accidently became pregnant while using Essure.
However, a study by data analysis firm Device Events discovered the actual number of Essure fetal death reports at 303. And, since only an estimated 25% of cases are reported to the FDA, the true number could be much higher.
Madris Tomes, chief data officer of Device Events, explained the discrepancy by noting that many deaths reported to the FDA were couched in terms such as “miscarriage”, “stillborn”, “stillbirth” and “fetal death.”
FDA Issues New Essure Warnings
In response to the report, the FDA on February 29th announced that it would require a new clinical study of Essure to assess dangers to women and fetuses, and also require that the product label and patient information be changed to warn women of the heightened risks.
The FDA is currently determining the details of the new study and is taking recommendations from the public on the language of the new Essure warnings.
Essure Lawsuits get the Green Light from Federal Court
Although the public is becoming increasingly aware of the dangers of Essure birth control, those victims affected by the device have been awaiting a decision by a federal court about whether they have the legal right to seek compensation.
In most cases, the Medical Device Regulation Act prevents patients injured by medical devices from filing lawsuits in state courts, if those devices were properly approved by the FDA.
However, last week, U.S. Federal District Judge John Padova of Philadelphia ruled that the Essure lawsuits of 5 different women may proceed on the basis of two claims: that Bayer used misleading information in advertising Essure; and that the company failed to warn patients about the risks.
Medical device injury lawyers are praising the decision, since it could give thousands of victims access to justice.
Anyone who has been affected by Essure side effects is urged to speak with a lawyer about their case as soon as possible. For more information, or to speak directly with a lawyer, contact DrugNews today.
Keenan, J. Fed judge rules case against Bayer's Essure birth control device to move forward. Fierce Medical Devices. (March 28, 2016). Retrieved from www.fiercemedicaldevices.com
Wasserman, E. FDA downplayed fetal deaths linked to Bayer's Essure contraceptive: Analyst. Fierce Medical Devices. (February 18, 2016). Retrieved from www.fiercemedicaldevices.com
FDA News Release. FDA takes additional action to better understand safety of Essure, inform patients of potential risks. (February 29, 2016). Retrieved from www.fda.gov
Last summer, the Department of Justice unveiled the details of an ongoing lawsuit and resulting settlement against industrial giant 3M, claiming the company had furnished defective combat earplugs to millions of U.S. troops serving around the world.
The FDA enacted tough new regulations this week aimed at making sure all women who are considering implantation of the Essure birth control device fully understand all the risks and benefits before moving forward.