FDA Response to Mirena Complications

Mirena IUD attorneys at Pintas & Mullins Law Firm warn users of this dangerous device about recent FDA warnings. Both the FDA and the Division of Drug Marketing, Advertising, and Communications (DDMAC) found claims made by Mirena representatives to be false, misleading, unsubstantiated, and in direct violation of federal standards.

In January 2010, the FDA sent Bayer a warning letter regarding its live consumer-directed program involving Mirena representatives who traveled to consumers’ homes. The letter stated that the manufacturer, Bayer, overstated the drug’s effectiveness, made claims that were not supported by evidence, failed to adequately disclose Mirena’s risks, and made false statements that misled Mirena consumers.

The letter also highlights that the product label includes numerous contraindications, and that use of this device carries numerous health risks that were not addressed in presentations. FDA warnings include increased risk of Pelvic Inflammatory Disease, ovarian cysts, ectopic pregnancy, and the possibility of permanent loss of fertility. Additional risks not addressed by the marketing tactic include Mirena embedding in, perforating, or expelling from the uterus.

Mirena representatives affirm that the device will help women “look and feel great,” which the FDA highlights is not supported by any real evidence, adding that Mirena patients may experience back pain, weight gain, and acne along with other side effects. The representatives also affirm that Mirena does not increase intimacy, romance, and sexual connection between partners. Any scripts making such claims must be supported by adequate and well-controlled trials, which Mirena has not conducted.

FDA notes that at least 5% of Mirena users reported a decreased libido, along with cramping, nausea, depression, and nervousness, which would actually adversely affect a couple’s intimacy or romance. Another false statement by Mirena’s manufacturers is that the drug’s users do not have to comply with a monthly routine. In reality, Mirena patients must be reexamined 4 to 12 weeks after insertion, and check that the strings attached to the device are in properly place each month.

A December 2009 letter from DDMAC to Bayer also illuminated problems with Mirena’s promotions. The letter included DDMAC’s change of position regarding Mirena’s risks and requested the company comply with the risk revisions within 90 days or before the next production of promotional materials. Bayer released promotions in February 2009, without the required changes in risks. The scripts continued to contain misleading statements that overstated Mirena’s benefits and minimized or simply omitted the risks.

Mirena is listed on FDA’s MedWatch, which is the agency’s pathway of relaying clinically important safety information and reporting serious problems. MedWatch posted information regarding Mirena in May and July of 2008 to include changes to warnings, contraindications, precautions, adverse reactions, and medication guide sections. The risks added in these periods include serious and potentially devastating effects, such as ectopic pregnancies (1 in 1000 Mirena users per year), sepsis, and breast cancer. Extensive modifications also occurred in the Precautions sections, including the possibility of masked symptoms and an extended list of patients who should use the device with caution.

Mirena IUD lawsuits involve victims who were implanted with the device and experienced severe complications. Our skilled Mirena attorneys are currently evaluating Mirena claims. Evidence shows that he manufacturer of Mirena made false and misleading claims to consumers and put them at risk of harm. A Mirena lawsuit helps prevent further harm to women by holding the responsible parties accountable.

Categories

Free Consultation
  • Please enter your first name.
  • Please enter your last name.
  • Please enter your email.
    This isn't a valid email address.
  • Please enter your phone number.
    This isn't a valid phone number.
  • Please make a selection.
  • Please make a selection.
  • Please enter your message.