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FDA Reports Textured Breast Implants Linked to Rare Blood Cancer

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According to a recent FDA safety update, as of February 1, 2017, the administration had received 359 medical device reports (“MDR”) of a rare type of non-Hodgkin’s lymphoma related to breast implants. Nine of those reports involved patient deaths.

This is the same cancer that was linked to breast implants in 2011. Back then, the FDA reported a possible association between “anaplastic large cell lymphoma (ALCL)” and breast implants, stating that “women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant.”

The administration warned doctors and women to be aware of this risk and to consider the possibility of lymphoma if breast problems occur a long time after implant surgery.

FDA Reports that Breast Implants Increase Risk of Rare Cancer

The FDA’s report suggests that there may be a greater risk of developing this cancer with textured implants than with smooth implants. Not all of the reports included information on the type of implant used, but 231 of them did. Of these, 203 were textured implants and 28 smooth implants.

Authorities have not identified why textured implants may have an increased risk, though they do know that body tissues grow into the grooves in textured implants to help keep them in place. Smooth implants are less “fixed” and can move more easily.

A total of 312 of the MDRs also included information on the implant fill types, with 186 filled with silicone gel and 126 with saline. However, the implant filling appears to be of less importance to the cancer risk.

The FDA notes that this information is far from complete, and there may be more cases of breast-implant-related ALCL that they are not yet aware of. Meanwhile, in a March 21, 2017 safety update, the FDA reported that it concurred with the World Health Organization’s designation of breast-implant-related ALCL as a “rare T-cell lymphoma that can develop following breast implants.”

It added that most of the data it had reviewed suggest that the disease occurs more frequently with textured implants than with smooth ones. It also advised healthcare providers to educate their patients about the risks before surgery and to discuss the benefits and risks of different types of implants with them. Further, surgeons should consider the possibility of ALCL when confronted with patients suffering from late onset, persistent peri-implant seroma, which is a pocket of clear fluid that develops near the implant.

ALCL Treatable with Chemotherapy

Anaplastic large cell lymphoma (ALCL) is a rare type of blood cancer that affects the lymphatic system. It causes the lymphocytes (white blood cells) to grow out of the control. These cells are part of the immune system and usually work to fight infections. In patients with ALCL, the cells build up in the lymph nodes and in other areas of the body like the lungs and skin.

Symptoms vary depending on where the cells build up. In a woman with breast implants, the symptoms usually show up near the site of the implant, in the form of a seroma, or the presence of a mass or hardness around the implant. Though seromas frequently occur after implantation, those associated with ALCL usually show up years after the implant was placed. Symptoms can also include redness and swelling, discomfort in the implant area, fatigue, and loss of appetite. A simple blood test can detect the presence of the cancer.

The good news is that the disease usually responds well to chemotherapy. Other potential treatments include radiation and stem cell transplants, as well as surgery to remove the affected area.

Women with implants who develop ALCL may be eligible to recover damages in court.