Calls In US For Device To Be Removed From Market

Concerns have been raised about the safety of Essure, a permanent method of birth control.

Essure had been marketed as a quick, non surgical method of permanently sterilising women. It was championed as an alternative to surgical methods which cut or seal the fallopian tubes.

The procedure involves placing soft, flexible inserts into the fallopian tubes, which carry the eggs from the ovaries to the uterus. Over a period of about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that prevents sperm from reaching the eggs, thus preventing conception.

Serious concerns have now been raised about the safety of the Essure method. There have been various reports of side-effects from the procedure, including severe headaches, nausea, allergic nickel reactions caused by the device, and colon perforation from the device moving inside patients.

In the US, the Food and Drug Administration (FDA), the government body which regulates medical devices, has said that since the product was approved in 2002 it has received over 900 reports of adverse events connected to Essure; these reports were mainly concerned with pain.

A thousand more complaints have been sent to the FDA in a voluntary reporting system. Consumer rights advocate, Erin Brockovich, is campaigning to raise awareness of the complications associated with Essure and to remove it from the market.

Bayer, the pharmaceutical company that manufactures Essure, has now changed the information booklet provided to patients in the US to include additional information on chronic pelvic pain and device migration – when the device moves.

The Essure method became available in the UK in 2009 and thousands of women have been inserted with the device. It is unclear how many women who have received the device in the UK have experienced complications.

Expert Opinion

It is worrying to hear reports about the safety of the Essure method, particularly as this was marketed as a less invasive form of permanent birth control. Patients who have been implanted with Essure are likely to be concerned by these reports. <br/> <br/>"It is vital that everything possible is done to ensure that patients get the right support on this matter and anyone with concerns should seek advice as soon as possible."