FDA warns of more cancer cases linked to breast implants

FDA reports more cases of cancer associated with breast implants

NINE women have now died from deadly cancer linked to breast implants

More women have been diagnosed with a deadly lymphoma caused by breast implants, according to a report released Wednesday from the Food and Drug Administration.

So far, 457 women in the USA have been diagnosed with anaplastic large cell lymphoma tied to breast implants.

According to the FDA, implants with textured surfaces are more closely linked to the cancer than those with smooth surfaces.

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.

In conjunction with Ashar's statement, CDRH's chief medical officer William Maisel sent a letter to healthcare providers updating them with FDA's latest analysis.

The report comes just over a month before the FDA is set to officially review the safety of silicone breast implants in a committee hearing.

Women with breast implants have an increased risk of developing anaplastic large cell lymphoma. Once the said cancer occurs in women who have breast implants, it will typically appear in the scar tissue around the implant. "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.

With the risk linked to breast implants, it is also vital that women who consider having an aesthetic operation be made aware of the symptoms of ACLC which include persistent swelling or pain surrounding the implanted area.

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. BIA-ALCL is a type of lymphoma and is not a cancer of the breast tissue. Smooth implants are softer than their textured counterparts, allowing for a more natural look and feel - but may lead to slightly visible rippling and shifting in position over time.

"For patients, we know the information regarding breast implants can be overwhelming, which is why we are committed to continuing our efforts to provide up-to-date publicly available resources to help understand the known benefits and risks of implants", Ashar said.

'In patients with breast implants, reported cases of BIA-ALCL were generally found adjacent to the implant itself and contained within the fibrous capsule'.

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.

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