Is Essure Safe?

Pharmaceutical giant Bayer recently sent out a press release announcing the continued safety of its non-surgical contraceptive, Essure. Earlier this month the New York Times published an article calling to question a study concluding Essure as a safe permanent contraceptive, prompting a public response from Bayer in defense of its product. Bayer’s public stance on Essure comes as the FDA has opened an investigation into claims of harmful side effects suffered by women who underwent the procedure.

Essure procedures were approved for use as a non-surgical alternative to permanent contraceptives in 2002, and have been since re-evaluated by the FDA in 2013 when Bayer purchased Conceptus, the company that designed the Essure device. The Essure device consists of small coils which are placed inside the fallopian tubes. Once in place the coils trigger an inflammatory response that causes scar tissue to form and block the fallopian tubes and prevent sperm from reaching the ovum. Recent legal claims against Bayer allege that manufacture and promotion of Essure has negligently put its users at risk of side effects including heavy periods, severe pelvic pain, and organ perforation.

Pharmaceutical giant Bayer recently sent out a press release announcing the continued safety of its non-surgical contraceptive, Essure. Earlier this month the New York Times published an article calling to question a study concluding Essure as a safe permanent contraceptive, prompting a public response from Bayer in defense of its product. Bayer’s public stance on Essure comes as the FDA has opened an investigation into claims of harmful side effects suffered by women who underwent the procedure.

Essure procedures were approved for use as a non-surgical alternative to permanent contraceptives in 2002, and have been since re-evaluated by the FDA in 2013 when Bayer purchased Conceptus, the company that designed the Essure device. The Essure device consists of small coils which are placed inside the fallopian tubes. Once in place the coils trigger an inflammatory response that causes scar tissue to form and block the fallopian tubes and prevent sperm from reaching the ovum. Recent legal claims against Bayer allege that manufacture and promotion of Essure has negligently put its users at risk of side effects including heavy periods, severe pelvic pain, and organ perforation.

After conducting a review of Essure legal claims and a study promoted by Bayer, the New York Times suggested that thousands of women have suffered from the device’s side effects and raised concerns about validity of the long-term data on Essure that Bayer released in April. According to the NYT, a citizens petition filed with to the FDA had record of over 16,000 complaints made about Essure between 2011 and 2013, and some women who use it are at risk for lasting pain or heavy bleeding due to side effects associated with the device.
In April, Bayer issued a press release to announce the publication of a study producing the only long-term data available on Essure use. The study, conducted over the course of 5 years between 2002 and 2007, tracked 518 women who received Essure devices for a five-year period to monitor their body’s response. According to Bayer’s press release, the study found that only 7% of the patients reported pelvic pain, none of whom suffered chronic pain during the duration of the study. Further, only three severe events occurred that could possibly be related to Essure, two of which required hysterectomies to repair damage. Citing the low number of reported incidents, Bayer concluded, “Essure is a safe and effective permanent birth control option for women when health care providers and patients follow the Instructions for Use.”

In its article, the New York Times took issue with the study in large part because the researchers only collected data from 366 of the 518 participants, which represents 70% of the women who volunteered to be part of the research. The New York Times also pointed out that 15 of the women had hysterectomies, but the study concluded that only 2 of these procedures could be linked to Essure. The Times also listed results not promoted in the Bayer press release, including:

• 38% of the women suffered unusually heavy periods on a recurring basis • 1 in 20 patents had recurring pelvic pain • 1 in 15 had recurring painful periods • 1 in 25 reported recurring pain during intercourse
Despite Bayer’s stance on Essure, the complaints from women who have undergone the procedure have given the FDA cause for concern. The agency has opened an investigation into the safety of the Essure device, and Bayer will need to respond publically to claims that their product poses a potential threat to women who use it. In addition to the FDA’s interest, women have filed lawsuits against Bayer alleging they did not receive adequate warning of the risk of painful side effects associated with Essure devices.

Pogust Braslow & Millrood is investigating claims of painful side effects caused by use of Essure as a non-surgical permanent contraceptive. If you or a loved one has suffered heavy bleeding, chronic pelvic pain, or another side effect of an Essure procedure, our firm is available for legal consultation.

For more information about Essure legal claims or how you can schedule a free consultation about your case, contact our experienced attorneys at www.pbmattrneys.com or call 1-888-348-6787.