German chemicals and pharmaceuticals giant Bayer will withdraw its controversial Essurecontraceptive implants from sale in the United States, the last country where they are available, more than a year after they were discontinued in Europe. Bayer’s decision to stop sales on December 31 “is based on a decline in US sales of Essure in recent years,” the group said in a statement, while insisting on its “safety and efficacy”. Essure, a non-hormonal coil implant used to sterilise women, has in some women caused chronic pain, perforation of the uterus and fallopian tubes and led to hysterectomies, news reports say. Bayer blamed a number of factors for lower sales, including “decreased use of permanent contraception overall, increased reliance on other birth control options… and inaccurate and misleading publicity about the device.” A tiny spring-shaped device, Essure is inserted under local anaesthetic into the fallopian tubes, blocking them in order to prevent fertilisation. It can be performed in the physician’s office.
Its withdrawal from sale in Europe last year followed European Union authorities’ suspension of sales of the implant while they gathered more data on safety. But while the US Food and Drug Administration (FDA) required Bayer in April to limit sales of Essure to medical practitioners who agreed to run through a checklist of the risks with patients before selling them the implant, it did not at any point stop sales. “The FDA continues to believe that the benefits of the device outweigh its risks,” the authority says on its website. It nevertheless adds that between November 2002 and January 2018, there were 26,773 “adverse event and product problem reports” submitted about Essure according to its database. The most common problems women reported were pain, heavier periods, headaches, fatigue and weight fluctuations, with most reports cataloguing multiple symptoms in a single patient.
Source : health.economictimes.indiatimes.
Published on: July 25, 2018