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Bayer announced that the U.S. Food and Drug Administration (FDA) has approved a label update for the Essure® System for Permanent Birth Control requiring healthcare providers to use the Patient-Doctor Discussion Checklist in order to purchase the product. The label now states that the sale and distribution of Essure is restricted to healthcare providers who counsel patients according to the approved label. The benefit/risk profile of Essure has not changed and remains positive.
Patients deserve the most accurate and comprehensive information to help them make their healthcare decisions, and Bayer has educated and continues to educate healthcare providers about the importance of appropriately counseling each patient on the benefits and risks of Essure. The FDA requested we update the label to emphasize this point.
The Patient-Doctor Discussion Checklist, which was added to the Essure label in November 2016, now includes the sub-title “Acceptance of Risk and Informed Decision Acknowledgement” to emphasize the importance of this tool. Bayer will continue to reinforce the use of the Checklist with healthcare providers and will inform them about this important label update.
Choosing a birth control method is a very important and personal decision. Bayer is deeply committed to providing women with safe and effective healthcare options that meet their individual needs, and is dedicated to ensuring the continued safe, effective and appropriate use of Essure as an important option for permanent contraception. As the FDA has repeatedly determined – after a rigorous review of the scientific evidence – Essure, the only non-incisional option available for those who seek permanent birth control, is a safe and effective medical device that benefits women by providing them with a valuable contraception option.
Essure is indicated for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes.
For Further Information
More on the laparoscopic device market in the U.S. can be found in a series of reports published by iData Research entitled the U.S Market Report Suite for Laparoscopic Devices. The full report suite includes market research data on laparoscopes, access devices, hand instruments, insufflation devices, suction-irrigation devices, direct energy devices, ultrasonic energy devices, hand-assisted devices, closure devices, gastric bands, powered morcellators, and female sterilization devices.
The iData report series on laparoscopic devices covers the U.S. and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxembourg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about laparoscopic device market data, register online or email us at [email protected] for a U.S Market Report Suite for Laparoscopic Devices brochure and synopsis.