303 Fetal Deaths May be Linked to Bayer HealthCare's Essure; Congressman Raises New Concerns About Contraceptive Device

February 18, 2016
By Alex Keown, BioSpace.com Breaking News Staff

WASHINGTON – U.S. Rep. Mike Fitzpatrick, a Pennsylvania Republican, fired off allegations Feb. 17 that Bayer HealthCare ’s permanent contraceptive device, Essure, is directly related to 303 fetal deaths. He also cited a court document alleging Bayer participated in illegal kickback schemes to lead to increased use of Essure.

In a Feb. 16 letter to the U.S. Food and Drug Administration, Fitzpatrick said in addition to the fetal deaths, the contraceptive device has spurred complaints from patients of various health problems, including “extreme pelvic pain,” heavy bleeding, weight gain, loss of teeth and hair, and other assorted symptoms.

“Tragically, this device has also killed innocent women and unborn children. The FDA’s public materials related to Essure have cited five reports of fetal deaths,” Fitzpatrick said in his letter, which is posted to his congressional website. However, he added that his office has independent reports of up to 303 fetal deaths.

Fitzpatrick requested the FDA conduct a review of the adverse events related to Essure. His letter was sent a few weeks before the FDA is expected to release new guidance on the use of Essure, following complaints raised about the device last year. In May 2015, a citizen’s group filed a petition with the FDA seeking to remove the device from marketplace due to side effects. In May, The New York Times reported since its approval in 2002, there have been more than 4,000 reports of complications, including those cited by Fitzpatrick, as well as the device’s coils piercing the fallopian tubes and penetrating other organs.

In September, the FDA Obstetrics and Gynecology Devices panel said use of Essure should be limited because not enough research has been performed to prove it is safe, Modernhealthcare.com reported.

To boost prescriptions of Essure, Fitzpatrick cited an unsealed complaint filed in the U.S. District Court for the Northern District of California alleging that Bayer Healthcare and Conceptus, Inc., the manufacturers of Essure, “gave substantial and illegal financial inducements to providers to encourage them to use Essure, a procedure that costs the government almost $3,500 per patient.” Fitzpatrick said the scheme cost U.S. taxpayers millions of dollars.

Essure is inserted into a woman’s fallopian tubes in a non-surgical procedure that usually takes about 10 minutes in a doctor’s office, Bayer said on the Essure website. Approximately 700,000 women have undergone such a procedure and the device claims to have a 99 percent efficacy in preventing pregnancy. Bayer acquired Essure through its 2013 acquisition of Conceptus Inc. for about $1.1 billion. Essure is forecasted to generate about $677 million in sales by 2020, according to a report in Seeking Alpha.

“According to the complaint, the manufacturer of Essure provided illegal kickbacks in the form of free medical equipment valued at $20,000. Additionally, the complaint alleges that the manufacturer of Essure would set up ‘referral lunches’ to generate business by connecting primary care physicians and Ob/Gyns to create what the manufacturer called ‘coin-operated doctors,’ designed to lead to the increased use of Essure,” Fitzpatrick said in the letter. “Furthermore, the manufacturer provided free marketing and advertising services to Ob/Gyns to encourage them to use Essure on their patients.”

In a statement posted on multiple news sites, including NBC, Bayer refuted Fitzpatrick’s allegations. The company denied any unreported deaths linked to the contraceptive device, saying the company has complied with all FDA rules in reporting adverse effects of the device.

“It would be irresponsible to suggest that Essure causes fetal deaths when, after an unsuccessful Essure procedure, an undesired pregnancy cannot be carried to term. In the post-market data, there is no data showing any increased risk of miscarriage and other complications compared to pregnancies in similar-age populations. Ectopic pregnancies and blighted ovum are not considered fetal deaths and can occur for a multitude of reasons not related to Essure,” Bayer said in its statement.

Regarding the allegations of a kickback scheme, Bayer said that complaint was investigated more than one year ago by the U.S. Department of Justice and has since been closed.