When Bayer settled its Essure contraceptive lawsuits for $1.6 billion, the mega company resolved 90% of the nearly 39,000 defective product lawsuits pending against it. But at least one media outlet is asking, “Did a social media campaign began in 2011 and boasting more than 42,000 members influence Bayer to settle?” The short answer is probably not. A company as large as Bayer is not easily swayed by a grass roots social media campaign. However, after its Roundup debacle, the ubiquitous company couldn’t afford another public relations debacle.
In addition to the social media campaign, the groups lobbied the FDA and Congress on behalf of those injured by the controversial contraceptive device. According to Cincinnati.com, ” For years, the U.S. Food and Drug Administration told the women that Essure was safe and effective. The Essure recipients hectored the FDA to reinvestigate the device, and two months ago, an interim FDA report said Essure patients “tend to have higher rates of chronic lower abdominal and/or pelvic pain and abnormal uterine bleeding compared to women who had laparoscopic tubal ligation as their permanent birth control.”
Patients had higher rates of surgery, including surgery to remove Essure, the interim report said. But perhaps most damning, the interim report found that Essure was not a significant advance in birth control over drugs or surgery. “Pregnancy rates are similar for patients with Essure and tubal ligation,” the report said.
Created by a small California biotech that was purchased by Bayer, the Essure device has been on the market since 2002. About 2 million units were sold around the world, and about 750,000 were implanted in the United States.
Unlike Essure, Paragard is a non-hormonal IUD that its manufacturers claim it is 99% effective. However, Paragard, which has been on the market since the 1980’s, the device can break and imbed in other organs. Lawsuits against Teva Pharmaceuticals, the Paragard manufacturer, claim the company failed to warn women about the possibility of breakage.
The current prescribing information provided by Cooper Surgical lists “device breakage” under the postmarketing adverse events section but doesn’t say how often it occurs. It does warn that “breakage of an embedded Paragard during non-surgical removal has been reported.”
Under the instructions for healthcare providers on how to remove the Paragard, it reads: “The threads can retract into the uterus or break, or Paragard can break, perforate the uterus, or be expelled.”
In addition, it cautions healthcare providers that, “Breakage or embedment of Paragard in the myometrium can make removal difficult. Analgesia, paracervical anesthesia, cervical dilation, alligator forceps or other grasping instrument, or hysteroscopy may assist in removing an embedded Paragard.”
There have been a few reports of device breakage in studies. Carlos M. Fernandez and colleagues did one such review in 2015. They concluded, “Though the safe and effective use of IUD contraception has been demonstrated in the United States, the possibility of its breakage should be recognized by clinicians.”
The potential for the copper Paragard device to break and migrate poses a significant risk to women. Removal of the device after breakage is difficult and can lead to other serious health complications. The manufacturer had a duty to warn women about these dangers but chose instead to market its non-hormonal benefits instead. It is too early to tell how Teva Pharmaceuticals will respond to the growing number of Paragard lawsuits. Time will tell if Paragard becomes another Essure-a dangerous product that made a lot of money for the manufacturer but caused much suffering to unsuspecting women.
