Went to the gynecologist because of pain - discovered broken copper coil in the uterus

Thousands of women have had the problematic copper coil, Novaplus T, inserted as a contraceptive. It has been found that the spirals break, usually in connection with its removal. Before the manufacturer became alarmed about the failure in February 2018, 13,707 women around Sweden had received spirals of the defective type inserted.

One of the affected women is Julia Klint who felt pain in the uterus for 1.5 years. When her gynecologist removed the spiral, he saw that it was broken and that a piece remained in the uterus.

- The gynecologist was shocked just like me. He said that during his 30 years as a gynecologist, he has not seen anything like it, says Julia Klint.

The cause should be a faulty plastic mixture where the barium sulfate, one of the components, clumps together. All spiral manufacturers worldwide are affected because everyone buys barium sulfate from the same supplier. The copper spiral was manufactured by a Spanish company, Eurogine, and sold in Sweden by the medical technology company Solann AB.

Since the care, in many cases, does not register the make and number of the spirals, the manufacturer does not want to replace the affected women.

It is not uncommon for health care providers not to register this information, says Helena Kopp Kallner, who is a doctor at Danderyd's hospital.

- I do not think it is done in all places and this is something that has come about because there are so seldom concerns with the contraceptives we have used. It is extremely unusual for spirals to break, says Helena Kopp Kallner.

- We now know that there is a spiral where, on the contrary, it is quite common for it to break, which means that in this case, the company would gain tremendous good-will in actually taking on the responsibility, says Helena Kopp Kallner.

The distributor in Sweden believes that it is not their responsibility to replace the women.

"We can't help the women for various reasons, but it is the manufacturer who has that responsibility," says Ann Strålman, Solann AB.

- The manufacturer has also received spirals from other makes, so they are keen to know which spiral the women had. They want to replace women who have had their spirals, says Ann Strålman.

In total, the Swedish Medicines Agency has received 12 notifications in Stockholm County regarding broken copper spirals and the notifications are expected to increase as copper spirals should be replaced every five years or removed when the woman wants to become pregnant. The product was manufactured during 2015–2017 and has been sold to all county councils in Sweden.

The Stockholm region has chosen not to procure the copper coil NovaPlus T, which is why not many of them have been used in Stockholm. However, it can occur in private care or other parts of the country.