Recently, the U.S. Food & Drug Administration, (FDA), approved another Intrauterine Device (IUD) to be manufactured by BAYER HEALTHCARE PHARMACEUTICALS, INC. (BAYER). This announcement was the subject of Press Releases, from BAYER, heralding their new product as an innovation and achievement in the field of female contraception. The new product has been trademarked – SKYLA and is a levonorgestrel releasing intrauterine system like the predecessor MIRENA. Intrauterine Device (IUD) and Intrauterine System (IUS) are used interchangeably when referring to such devices and are a thinly veiled play on words rooted in efforts to creat distance between ‘new’ devices and the ill fated Dalkon Shield IUD.
On January 9, 2013, BAYER announced that the FDA had approved this new hormone-releasing system for the prevention of pregnancy for up to 3 years. In contrast, MIRENA is a 5 year hormone-releasing IUD.
With growing concerns in Europe over high risk contraceptives, many linked to BAYER’S DROSPIRENONE famliy of pills (YASMIN, YAZ, BEYAZ & SAFYRAL) the company has invited more litigation and fuel to a growing number of MIRENA LAWSUITS. Our prior blog post regarding DROSPIRENONE appear here .
SKYLA is a "T" shaped device with 13.5 mg of levonergestrel, it is described as being 28mm x 30 mm. In comparison, the MIRENA IUD is a 32mm x 32mm device. BAYER’S Press Release touts the product as a way of empowering women with a variety of contraceptive choices in their respective life cycle. However, given mounting lawsuits involvling MIRENA, as well as thousands of still pending lawsuits involving their novel DROSPIRENONE line of contraceptives, one can openly wonder if they are empowering women or simply their bottom line. Arguably, it is the latter as there is no claim that SKYLA is a new and improved version of MIRENA. Rather, it is another option in the line and potentially a way of ‘evergreening’ their patent and perceived leadership in the hormone releasing contraceptive space.
BAYER’S enthusiasm in broadening their portfolio will lead to questions about projected sales. Aren’t they cannibalizing their own demographic by offering two levonorgestrel releasing IUD’s as options? If it did not make business sense it is unlikely that they would offer it. In a related news release (visually depicted above), Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals, was quoted as follows:
"The approval of SKYLA expands Bayer’s IUD portfolio and highlights our continued commmitment to empower women with a variety of birth control options at different reproductive stages of their lives…..[W]e are pleased to bring the first new IUD to market in the U.S. in 12 years, and to provide women who are seeking contraception with an important new and effective option to consider with their healthcare providers."
Like MIRENA, SKYLA comes with distinct risks associated with the use of an implanted hormone releasing device.The risks include, but are not limited to the following:
FDA’s approval was reportedly based upon data from a Phase 3 Trial that included only 1,432 women ranging from age 18-35. Of these, 556 or 38.8% had not yet had a child. Certain women with pre-existing conditions were excluded which included the following: women less than 6 weeks postpartum, any history of ectopic pregnancy, clinically significant history of ovarian cysts or HIV, as well as women at high risk for sexually transmitted infections. Notably, 21.9% of the women discontinued, or dropped out of the SKYLA study due to the following:
Despite scrutiny over riskier birth control pills in France, as well as Switzerland (discussed here), BAYER will seek to offer the new SKYLA IUD globally. In Europe, BAYER plans to market SKYLA as JAYDESS, after having concluded the European registration process in December 2012.
In the past decade, the MIRENA IUD has amassed over 45,000 reports of adverse events with the FDA as reported by www.AdverseEvents.com for "MIRENA". Are those reports enough to raise red flags or constitute ‘safety signals’ for healthcare providers and FDA? You would think the answer is a resounding and emphatic – yes.
SKYLA has the potential to reach a broader audience of girls and women which may raise red flags with many that have studied MIRENA. Why? MIRENA was initially approved for women that had at least one child and chose the IUD as a form of contraceptive. With SKYLA BAYER has a new, and arguably younger demographic in mind, regardless of whether or not they have ever been pregnant. In recent months the medical community has conveniently begun embracing the idea, through public announcments, that IUD’s were safe and effective enough to consider using in girls and women regardless of whether they had previously been pregnant.
Breaking news heralding SKYLA as some improvement or step forward emposwering girls or women should meet significant skepticism given MIRENA’s legacy, BAYER’S history in female contraception and the thousands of stillp pending DROSPIRENONE lawsuits, as well as nearly 1/4 of the SKYLA particpants dropping out of the study the FDA relied upon the approve this option for young fertile women in the cross hairs of impending marketing efforts globally.
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