New Bayer IUD Approved in Europe

Mirena IUD attorneys at Pintas & Mullins Law Firm warn the American public of Bayer’s newest IUD, Jaydess, which was recently approved in Europe. Bayer has also submitted a marketing application for Jaydess in the United States.

Bayer is a German pharmaceutical and chemical company responsible for the development and manufacture of the Mirena IUD. Mirena has come under immense fire in the past few years for its devastating side effects, which include serious and debilitating injuries, and often require corrective surgery.

Jaydess will provide IUD pregnancy prevention for up to three years. The European approval was based on a phase III clinical trial involving over 1,400 women aged 18-35. Nearly 40% of those women had not yet had a child – a staggering statistic for American readers, who may remember the Mirena commercials that specifically note that the device should only be used by women who have already had children. This discrepancy is seemingly minor, however, the reasons behind it are extremely troubling.

There are numerous ways Mirena could cause the permanent loss of fertility in its users. Should a woman become pregnant while using Mirena, which could occur due to device migration or other defects, there is a serious risk of the woman not only losing that pregnancy, but permanently losing the ability to reproduce altogether. According to the FDA, about half of pregnancies that occur with Mirena are ectopic, meaning the fertilized egg implants outside the uterine cavity. A major risk associated with ectopic pregnancies is the loss of fertility. In clinical trials in the United States, 1 ectopic pregnancy occurred per 1000 users per year. Mirena also carries an increased susceptibility to pelvic infections, such as pelvic inflammatory disease (PID). In the United States, up to 10 to 15% of women may become infertile as a result of PID.

It is unclear whether Bayer’s former negative relations with the FDA will influence their decision over Jaydess. In January 2010 the FDA sent a warning letter to Bayer regarding some of its marketing tactics. The letter accused Bayer of overstating the drug’s effectiveness, making claims that are not supported by evidence, failing to adequately disclose Mirena’s risks, and making false statements meant to mislead Mirena consumers.

Jaydess is expected to launch in the second quarter of 2013. Bayer’s current contraceptive franchise is led by the Yaz/Yasmin/Yasminelle oral drugs. In response to the increase of litigation charges concerning these products, Bayer added warning labels earlier in 2012 indicating that they may increase the risk of blood clots. Jaydess is the company’s solution to many of these serious side effect reports. The IUD is only offered in a low-dose, and lasts three years, compared to Mirena’s five and option for higher doses. Bayer claims that Jaydess will reduce women’s exposure to hormonal drugs.

The high number of women without children involved in the clinical trials is evidence that Bayer is trying to improve its IUDs to be safer in younger consumers. The Chief Marketing Officer for Bayer HealthCare affirms that this is exactly the target for Jaydess – stating that he hopes the low dose will appeal to younger women who have not yet had children.

Side effects of of Mirena are vast, and reports are only rising. Very common adverse reactions, occurring in more than 10% of users, include irregular bleeding, ovarian cysts, and amenorrhea. Serious reported side effects include seizures, device migration, and even death. In some cases, these reactions did not stop after removal. If you used Mirena and experienced any serious health complications, particularly those requiring surgical removal, you may be entitled to compensation.Drug recall attorneys at Pintas & Mullins Law Firm are currently evaluating Mirena cases.