FDA Alerts A Rare Form Of Cancer Associated With Breast Implants

FDA Alerts A Rare Form Of Cancer Associated With Breast Implants

Among plastic surgeries, breast augmentation or breast implant is one of the most frequently requested, being used for several purposes: as reconstructive surgery of the breast after mastectomy after breast cancer; to correct congenital defects of the breast, such as as asymmetry and in cases of congenital defects of the chest wall. FDA Alerts A Rare Form Of Cancer Associated With Breast Implants.

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If performed as a cosmetic surgery, its function is to increase the size and or modify the shape and texture of the breasts.

There are basically two types of breast implants. One filled with saline solution and the other with liquid silicone or firm gel. Both constituents are covered by a layer of silicone. In addition, according to their texture, there are smooth and textured.

Recent data obtained by an investigation of the International Consortium of Investigative Journalists (ICIJ), determined that more than 10 million women in the world have undergone augmentation mammoplasties during the last decade. Despite the scandals involving safety problems, reports about their relationship with different types of cancer and even a period of prohibition for this surgery that ruled in the United States.

Review of a Dangerous Finding

In 2011, the FDA identified a possible relationship between breast implants and the development of a rare form of cancer. Anaplastic Large Cell Lymphoma (ALCL).

At that time, the FDA had few ALCL reports. So, it was not possible to determine which risk factors predisposed a patient.

As time went by, the understanding of this pathology increased. Until in 2016, the WHO disseminated that the ALCL corresponded to a T-cell lymphoma that may develop after placement of breast implants.

For its part, the FDA, after having tracked the reports of this lymphoma for several years, officially confirmed its link with breast implants in 2017.

In terms of statistics, most data suggest that ALCL occurs more frequently in the case of breast implants with textured surfaces compared to smooth surfaces.

According to estimates, this neoplasm is diagnosed in one out of every 500,000 women. Which makes it a very rare cancer.

Within one year, 3 out of every 100 million women would be diagnosed, approximately. Although there is no consensus on the exact frequency of this disease.

Characteristics of the ALCL

FDA Alerts To Rare Form Of Cancer Associated With Breast Implants
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It is necessary to clarify that this malignant neoplasm does not correspond to breast cancer. It originates from a type of T cells (from the immune system) that is generally formed in the scar tissue that grows around the implants. Causing the first signs and symptoms of the disease to be swelling, lumps and pain around the breasts.

This Anaplastic large cell lymphoma, apart from the breast, may grow in other parts of the body. But, most of the women who were diagnosed with ALCL were due to the accumulation of fluid around the implant (Seroma) after some years of surgery.

In other cases, direct seroma analysis led to diagnosis. Some less frequent findings a mass was found in the breast or it was because the breast tissue capsule tightened (capsular contracture) and caused discomfort or aesthetic alterations.

In general, the average time from implant placement to ALCL development is 7 to 10 years.

Since its usual location is in the scar tissue capsule that forms around the implant, this lymphoma can be successfully treated by removing the implant and the associated capsule. Additional treatments such as radiation therapy and chemotherapy are generally not necessary.

Warnings and Cautions

FDA Alerts To Rare Form Of Cancer Associated With Breast Implants
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U.S. health officials are warning family doctors, nurses, and other health professionals about this form of lymphoma that affects breast implant patients after receiving more reports of the disease.

In suspected cases of ALCL, the FDA recommends laboratory tests to confirm or rule out the disease.

This is the first time that health agencies issue a direct warning to physicians other than plastic surgeons, since patients often seek care from their primary care physicians, gynecologists or other health professionals, rather than a plastic surgeon.

The FDA said, through its spokeswoman, Stephanie Caccomo: “Having everyone informed about this is best for the patient”.

The FDA warning applies to all types of breast implants, whether they contain saline or silicone. But U.S. and foreign experts have focused especially on textured implants, which correspond to a small segment of all breast implants used in the United States, according to Dr. Alan Matarasso, president of the American Society of Plastic Surgeons, who added: “The vast majority, if not all cases, have been in patients who at some point had some type of textured implant.

In addition, as a formative measure, the FDA indicated that it will hold a two-day meeting on the topic: breast implant safety.

In November, French health institutions advised plastic surgeons to stop placing textured implants. This, until more is known about their connection to lymphoma.

FDA ALCL Cases

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Current figures indicate that it is a very rare cancer, considering that about 400,000 American women receive implants annually.

The FDA reported that they have identified 457 probable cases of this cancer as of 2010. Including the deaths of nine patients. In each of these reports, the disease was diagnosed by a physician or through specific laboratory tests.

In addition, the entity said it received nearly 250 new reports from ALCL in the past year. Although many were duplicate reports or lacked important information to confirm them.

But the FDA’s efforts to control breast implant problems have been hampered by an ineffective system for tracking injuries and malfunctioning medical devices.

Since the electronic database that has been in operation for decades is based on handwritten submissions from health and insurance companies, physicians, patients and attorneys, who often attach incomplete and unverified information.

This make this follow-up even more difficult. As these inaccurate reports could indicate that the true prevalence of this lymphoma in the population is being underestimated.

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