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New scandals for breast implants Aftonbladet

Photo: Illustration: Christina Chung / ICIJ / TT

About 10 million women have received breast implants in the last decade. Many people have a problem. 170,000 worked last year.

Photo: Lionel Tsironne / AP / TT

Defective breast implant implanted by French manufacturer PIP. The company's scandal products were placed in 400,000 women, of which 4,000 in Sweden, in the world. Only 16,800 were operated in France. Stock photography.

Dangers with breast implants are now more and more noticeable when some products are associated with an unusual form of cancer.

Other implant problems are more common than previously known, shows a global overview.

The French drug agency became the first to advise the so-called implants with impregnated textures. Then, journalists, coordinated by the ICIJI reporter network, asked questions about suspicious product risks.

All over the world, plastic surgeons have identified 615 cases of BIA-ALLK, implant-related lymphatic carcinoma, of which 53 are only in France. In Sweden there are six known cases according to the Brimp Register of Breast Implants. This disease is much more common in women with rigid implants than with smooth, although causal relationships have not been cleared.

Svenska Läkemedelsverket estimates that "it is still too early for a recommendation on the Swedish market," but you think that you should contact your healthcare provider if you are concerned.

Fredrik Ghevali, president of the Swedish Association for Aesthetic Plastic Surgery, in turn wrote about the organization "Since 2016, it is cautious about using implants with macrotext implants" and that its members use mainly other products. Guavali also notes that BIA-ALLL is very rare. The medical organization, the Swedish Association of Plastic Surgery, did not answer TT questions about the problem.

Autoimmune diseases

However, from implants that operated in Sweden in 2017, known for "Brim", 88 percent – 4,664 pieces – were percussion models, according to the annual report of the registry. Briba is also concerned about products that are "introduced in a non-critical and non-scientific way in Sweden".

Several studies have also suggested that some so-called. Autoimmune diseases, such as arthritis rheumatoid arthritis, are significantly more common in implant women, although it is not clear why. At that risk, the Medicines Agency only answers that the agency has no ongoing investigation.

Brim has registered about 65 percent of all implants in Sweden, about 19,000 by 2014. In total, more than 10 million women worldwide have received breast implants over the last decade, according to an international audit.

Shoot in height

The best statistics on the incidence and damage suspected of being implanted can be found at the FDA in the United States. Your case also reports on foreign cases.

And the numbers show that problems with breast implants were much greater than what is known. The FDA has allowed manufacturers to cover up the scope, since broken implants and other injuries are considered routine events that should not be reported.

When these figures are now included, reports have declined from an average of less than 200 per year to over 4,500 in 2017, and more than 8,000 in the first half of 2018 alone. It shows the analysis of ICIJ with its partners, including TT and SVT done in its global overview of medical devices.

"The problems were there all the time," said Madis Toms, who worked with FDA injuries reports. She is the founder of Device Events, a company that tracks such reports and discovered the increase in the number of breast implants in 2017.

However, the FDA does not see an increase as a "new public health issue".

Europe too

This trend is coming back to Europe. Here, some manufacturers did not report broken implants at all, according to the Dutch authorities.

In Sweden, the number of incidents and injuries reports has also increased, several times a year to 63 in 2018 (until November 6), due to different reporting routines by manufacturers. The most common problems are that the implants are broken or compressed. Which products have caused problems, the Swedish Drugs Agency can not say "because it can be assumed that the companies in question may suffer damage if data is corrected".

The major manufacturers Alergang and Mentor say their products are safe.

Most people who have breast implants are satisfied, but remarkably many dismiss them – nearly 170,000 women around the world in 2017, according to a study. The FDA warns openly that every fifth woman will need to remove breast implants within a decade because they break, collapse, or when the scar tissue around them pulls together and causes pain.

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