FDA: Additional cases of cancer linked to breast implants

Women with breast implants have an increased risk of developing anaplastic large cell lymphoma

On Wednesday, the U.S. Food and Drug Administration's Dr.Binita Ashar Federal Drug Administration released a statement on the danger of women getting cancer after having breast implants.

The agency says at least 457 women in the US have been diagnosed with anaplastic large cell lymphoma. "Of those, nine have died as a result of the rare cancer, which affects cells in the immune system and can be found around the breast implant".

As of September 2018, the FDA has received 660 adverse event reports regarding cases in the USA, linked to 457 unique cases of the disease and nine patient deaths, the agency said.

The FDA also announced it will be sending letters to doctors, urging them to learn about ALCL.

This "makes it more hard to know if any particular breast implant characteristic is associated with BIA-ALCL or if higher reports of BIA-ALCL are simply due to higher implantation rate of a particular manufacturer", Ashar said.

"Though the number of identified cases of BIA-ALCL is small compared to the estimated 1.5 million patients who receive breast implants worldwide every year, confirmed data and published information reviewed to date suggests that patients with breast implants have an increased risk of BIA-ALCL", Maisel's note said. "Choosing to obtain a breast implant is a very personal decision that patients and their providers should make based on individual needs and with the most complete information about products", Ashar said.

Those who already have implants should look out for new swelling, lumps, or pain around them.

The amount of women diagnosed with BIA-ALCL - which kills cells in the immune system and normally begins with pain and swelling in the breast - shot up from 414 cases in the last 12 months and 359 the year before that.

The FDA, knowing its critical role on the health of women, initially informed the subjects on the associated risk from textured breast implants in 2011.

However, the majority of ALCL cases have been linked to the textured devices.

"When breast implants are placed in the body, they are inserted behind the breast tissue or under the chest muscle", the letter said. Textured implants have been shown to more frequently associated with the disease than those that are smooth, though the surface type of implants is not always reported at time of diagnosis.

A large manufacturer of breast implants, Allergan, suffered internationally in December when France issued a mandatory recall of textured breast implants, and shortly thereafter Allergan lost its CE mark.

The report also detailed that most of cancer cases were found in women with textured surfaces on the implants rather than implants with a smooth exterior.

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