The FDA announced that its Obstetrics and Gynecology Devices Panel will discuss scientific data regarding the safety and effectiveness of Bayer’s BAYRY contraceptive device, Essure, in a public meeting on Sep 24, 2015. Essure is a non-surgical permanent birth control device that involves placing inserts into the fallopian tubes.
We note that Essure had received FDA approval in Nov 2002. Since then (as of May 31, 2015) the FDA has received 5,093 complaints. After Essure placement, some women experienced pain, heavier menses/menstrual irregularities and headache. Certain reports include symptoms that were not included in the labeling and not observed in post-approval studies, or described in the clinical literature such as extreme fatigue, depression and weight gain.
Additionally, multiple device related problems were reported including patient device incompatibility, migration of the device or device component, device operating differently than expected, device breakage and malposition of the device. Reports of five fetal deaths in women who became pregnant after using Essure and four deaths of women who used the device have also surfaced.
The FDA noted that although these reports will contribute to the detection of device-related safety issues and benefit-risk assessments, they may be incomplete, inaccurate, untimely, unverified or biased.
We believe that investor focus will be on the outcome of the FDA panel meeting. Several companies including Merck & Co. Inc. MRK markets contraceptives in the U.S.
Bayer carries a Zacks Rank #2 (Buy). Other well-ranked stocks in the health care sector are Valeant Pharmaceuticals International, Inc. VRX and Acorda Therapeutics, Inc. ACOR. While Valeant holds a Zacks Rank #1 (Strong Buy), Acorda carries the same Zacks Rank as Bayer.
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