September 17th, 2018|
As advancements in biomedical technology continue to create new opportunities for convenient and painless solutions, more and more products are appearing on shelves and in hospitals with the promise of providing an easy fix to any medical problem. Aside from creating treatments for currently incurable diseases, streamlining medicinal processes is arguably the largest focus of the medical research and manufacturing communities. As a result, one of the subsections of medicine that is changing rapidly is that involving contraceptives. Between pharmaceutical, non-invasive, and invasive methods, individuals seeking birth control have countless contraceptive choices, many of which come at a relatively low cost.
Until recently, one of the more popular choices was the device owned by Bayer AG known as “Essure,” which was intended to be an easy long-term option for women hoping to prevent unwanted pregnancies. As Essure’s website explains, “Essure is permanent birth control that works with your body to prevent pregnancy. In this procedure, a soft, flexible insert is delivered through the vagina and uterus and permanently placed in each fallopian tube. No incision is required to deliver or place the inserts and general anesthesia is not required.“ The message the company clearly hoped to convey was that its product would be relatively free of discomfort and complications compared to other long-term contraceptive options.
Essure thus seemed to be a safe alternative for those worried about potential complications of an IUD or contraceptive pills, but who still wanted something that could be used over a long time horizon. The device’s benefits were recognized by a significant number of women throughout the world. As the Washington Post reported in July of last year, over ¾ of a million units had been purchased by that time. While this does not place Essure among the most widely used forms of contraception, it represents a then-growing trend towards this supposedly painless and problem-free option.
As is almost always the case with any medical treatment, however, there were bound to be side effects. Surprisingly, the problem with Essure came not with the side effects themselves, but in a failure to communicate that these side effects existed. Unfortunately for the women who had opted to use Essure, it seems as if the pros and cons of the device may not have been accurately reported, resulting in misinformed patients who may not have chosen to have the device implanted had full disclosures been made. As Bloomberg reported, “U.S. regulators found that some doctors weren’t always telling women about the Bayer device’s risks, which can include bleeding, pain and organ damage.” While bad PR from these discoveries and a consequent slump in sales resulted in the company pulling their product from the market, the damage had already been done. Many women around the world who had not been given the proper warnings and information about the potential hazards of Essure already had it implanted and would therefore have to undergo yet another procedure to have the device removed. Worse still, those who had suffered organ damage from the device had potentially sustained irreparable damage due to the neglect of their physicians.
Along with the company’s choice to stop marketing their device, the FDA placed new regulations around Essure to ensure that a lack of information couldn’t create more problems than it already had. As the FDA explained, “The patient must be given the opportunity to sign [a form that says that they have been informed of the potential downsides of Essure], and it must be signed by the physician implanting the device.” This was certainly a step in the right direction. If Bayer decides to resume marketing the device, these regulations will hopefully prevent further miscommunications from occurring. Still, these cautionary measures cannot retroactively help the women already damaged by the massive break in Essure’s information channel.
To say that this blunder was the sole fault of the healthcare providers would be unfair and incorrect. While the physicians must shoulder some of the blame and make sure the patients have full disclosure about the side-effects going forward, the FDA’s regulations are designed to ensure that Bayer does its part as well. In this respect, the FDA has ruled that Essure must come with “approved labeling to be provided by Bayer” — clearly in an effort to keep every member of the production-to-client supply chain responsible for their part in making Essure safe.
Not surprisingly, many Essure users who were not given the disclosures are upset by such an easily avoidable mistake resulting in physical harm. Since the news broke that the side effects of the device were not being accurately portrayed, Essure users have been seeking compensation for their damages in droves. Especially in an industry as monopolized and known for profiteering as pharmaceuticals, this may be a special opportunity for a massive group of people to stand up against what was obviously a preventable consequence. While some may never be able to fully recover from the harm caused by the shortcomings of Bayer and their individual healthcare providers, people who have been affected by such a lack of information have the chance to be compensated for their injury. Not only does this create an opportunity for retribution and justice, but it also means that victims may be able to get the necessary funds for the treatment they need due to their Essure-related damages.
At Nurenberg Paris Heller & McCarthy, we recognize the need for experienced lawyers to handle this important and consequential case. The suffering that resulted from the breaks in this information chain was avoidable, and as a result, those who suffered due to neglect are entitled to proper compensation. If you or a loved one has been harmed through the use of Essure without having been informed of the potential risks, call Nurenberg Paris today for a free consultation and to discuss how you could begin the process of getting the justice you deserve.