Essure contraceptive device is withdrawn in the EU.- Bayer

Bayer has announced that it is discontinuing all sales and marketing efforts of the Essure permanent contraceptive device in all European markets. Bayer states in its press release that the decision to end sales of the product in these regions is not due to a safety or product quality problem and is instead being made for commercial reasons.

The company states that the device�s positive benefit-risk profile remains unchanged and that its safety and effectiveness remain supported by more than ten years of scientific research and real-life clinical experience. The FDA recently agreed with Bayer in the company�s assertion of the benefit-risk profile The Essure device will remain on the market in the U.S.

Comment:It has beeen reported that some women were experiencing strong levels of pain and discomfort due to the device. Some women were reported to have had to undergo surgery to have their uterus removed. In a premarketing study of the device, Bayer states that 12.9% of women experienced mild to moderate pain, 29.6% experienced vaginal bleeding and 6.8% experienced pelvic or back discomfort.