Bayer pulls plug on sterilisation device after numerous complaints
pharmafile | September 21, 2017 | News story | Sales and Marketing | Bayer, Essure, biotech, drugs, pharma, pharmaceutical
Bayer has stopped the commercial sale of a sterilisation device in all countries, except the US, after reports that it left women with chronic pain and even needing hysterectomies.
The implant, called Essure, is a coil that is designed to cause inflammation and scar tissue as part of its function, but was found to cause serious discomfort in a number of women.
The coil is made of nickel and polyester fibres that are inserted into the fallopian tubes, with the inflammation it causes designed to prevent eggs reaching the womb. Due to the way to the device has been designed, it left many women with no choice but to have their fallopian tubes, or even their uterus, removed to rid themselves of the implants.
The website advertising the product describes it as “a minimally invasive procedure, Essure placement requires no cutting, leaves no visible scars, and can be performed in your doctor’s office.”
In a press release on its French website, the company announced in a statement, translated from the original French: “We would like to reassure patients, particularly those with Essure, and all the healthcare professionals who accompany them, that this decision is not linked to a safety or product quality problem.”
The FDA reportedly received 5,093 complaints over the course of 13 years of the product being on the market. There have also been four reported deaths associated with the device, due to the infection and uterine perforation.
However, the FDA has insisted that it has safely adjudicated the benefit/risk profile of the device and that it is able to remain on the market. Bayer’s product was given a new label in 2016, which warns of potential adverse events.
Meanwhile, the UK’s MHRA has been criticised for failing to respond to complaints and rejected a recent television show’s request for details of how many recipients of the device had endured complications.
Ben Hargreaves
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