-Jennifer Lawrence and Rob Lewis
Recently, the New York Times featured an article about the many problems associated with the Essure contraceptive implant: “Bayer’s Essure Contraceptive Implant, Now With a Warning”. See R.C.Rabin, New York Times, Nov. 21, 2016, http://www.nytimes.com/2016/11/21/well/bayers-essure-contraceptive-implant-now-with-a-warning.html. The article discussed a woman, Kim Myers, who began having “sharp, labor like pains” after having Essure implanted. Despite having the devices removed, the pain continued for three more years. Ultimately, she had to have a hysterectomy. After the hysterectomy, the cause of the severe pain was discovered: a portion of the Essure device, a piece of metal coil, had become embedded in her uterus. According to the article, Ms. Myers was among “a parade” of women who testified before the FDA who had been injured by Essure in similar ways and who urged the FDA to remove the device from the market. Despite extensive testimony and a concession by the FDA that many women with Essure implants had experienced “very serious and sometimes debilitating problems”, the FDA refused withdraw the device. The NYT article cites Bayer representatives as blaming either the doctors (claiming that poor surgical skills are to blame for the complications) or the patients (denying that chronic pain and autoimmune disorders are caused by the device). See id.
Essure received FDA approval in 2002 after a “fast-track review process;” that pain and other serious side effects emerged in the clinical trials of Essure; that the device could not always be implanted and/or failed to block the tubes in a significant percentage of patients; and that nearly one in 10 women who try Essure cannot rely on it to prevent pregnancy. See id. Nonetheless, the FDA approved Essure, a device meant to last for life, “after trials lasting a year or two” and as of the end of 2015, the FDA had received nearly 10,000 reports of injuries and pregnancies related to the device, as well as reports of a very small number of fatalities. See id. The article also notes that the true complication rate is unknown because Bayer “would not provide United States sales numbers, which also would not reflect the actual number of women who have received implants, because no one knows how many of the devices have been implanted in the United States.”
Finally, in mid-November, the FDA took heed of some of the complaints and ordered a warning be placed on the Essure packaging. The black box warning is to state the following:
WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System for Permanent Birth Control during discussion of the benefits and risks of the device.
The warning included precisely the type of problems described by Ms. Myers and the other women who testified before the FDA.
The FDA took the “unorthodox step of guiding Bayer in the development of a new checklist of risks for doctors to review with patients before implanting the device.” See http://www.nytimes.com/2016/11/21/well/bayers-essure-contraceptive-implant-now-with-a-warning.html. The checklist is three pages long and has blanks for patient initials at the end of each of its five sections. As mentioned, “the checklist is not mandatory, and critics say it does not mention many common side effects linked to Essure, like heavy, painful menstrual bleeding” and “some providers, including Planned Parenthood, have said they will inform patients of the risks and benefits, but not ask them to sign the document.” A decision that appears to be supported by the American Congress of Obstetricians and Gynecologists (ACOG) whose vice president of practice was quoted as saying, “Decisions like these should be made based on data that’s appropriately vetted, not a series of anecdotal reports,” in reference to the black box warning and the checklist. A copy of the warning and the checklist is attached at this link. http://labeling.bayerhealthcare.com/html/products/pi/essure_pib_en.pdf
What is glaringly apparent is that Bayer not only has failed to take any responsibility for the significant injuries caused by Essure, but has also failed to provide data and information necessary to evaluate the risks of its product while attempting to shift the blame to others for the failures of its device. Essure continues to remain an extraordinarily dangerous product.
If you or your loved one has had Essure implanted and has had problems with the device moving or migrating and injuring other organs, pain, bleeding, pregnancies, loss of a child or a hysterectomy, please call The Lawrence Firm, PSC at 800-698-4054 or email our office at [email protected] for further information as to your rights or your loved one’s rights against Bayer.