In Brief: Restrictions on Essure

Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement " with their patients before implantation. The checklist includes information about the device, its safety, and its effectiveness. Patients and physicians must sign the checklist before the device is implanted.From its approval in 2002 through 2017, the FDA received 26,773 medical device reports related toEssure. The most common adverse effects reported with its use were abdominal pain, heavier menses/menstrual irregularities, headache, fatigue, and weight fluctuations. Nickel allergy, migration of the device, dislodged or dislocated device, and device breakage have also been reported. During this time period, there were 1863 pregnancies (365 live births, 875 miscarriages, 623 unspecified) and 13 deaths (8 adults, 4 infants after live birth, 1 unspecified).2Bayer states that more than 750,000 women have receivedEssure worldwide, but the device was taken off the market in the United Kingdom, the Netherlands, Finland, and Canada, and Bayer stopped sales ofEssure outside the US altogether in September 2017.Some women with contraindications or intolerance to hormonal contraceptives are also poor candidates for laparoscopic tubal ligation, leaving them few options for highly effective contraception. For these women, in the US,Essure remains an option.Choice of contraceptives. Med Lett Drugs Ther 2015; 57:127.FDA activities: Essure. Available at:www.fda.gov. Accessed May 10, 2018.Download complete U.S...
Source: The Medical Letter - Category: Drugs & Pharmacology Authors: Tags: Contraceptives Essure Oral contraceptives Source Type: research