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Are Silicone Breast Implants Safe? FDA Meets to Decide

Glass & Robson > Blog  > Are Silicone Breast Implants Safe? FDA Meets to Decide

Are Silicone Breast Implants Safe? FDA Meets to Decide

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Recently, the Food and Drug Administration (FDA) agreed to hold a 2019 meeting between top public health advisers and regulators in the United States. The topic? Whether or not silicone breast implants are safe.

A new study of more than 100,000 women with silicone breast implants had some troubling findings. This study, the first of its kind since 2006, is one of the largest long-term safety analyses of silicone implants. The implants were previously taken off the market for 14 years due to health and safety concerns.  Two of the largest manufacturers of silicone gel-filled breast implants are Allergan and Mentor.

Despite the limitations of the study, researchers agree that it is vital to present this information to the public so women can make informed decisions before proceeding with a breast implant surgery.  This is particularly important considering 400,000 women choose to undergo breast implant surgery each year – the majority for enlargement purposes and the rest for reconstruction after cancer surgery.

 

What are the safety concerns for silicone gel-filled breast implants?

According to the FDA, breast implants are not built to last for a lifetime. About 20% of women with breast implants have them removed within 8-10 years. This is often due to tears, infections, pain, swelling and more.

Even more concerning is the recent claim that silicone gel-filled breast implants can contribute to an increased risk of a rare lymphoma, which is a type of cancer. This cancer is called BIA-ALCL.

 

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

The World Health Organization (WHO) announced in 2016 that BIA-ALCL is a T-cell lymphoma that can develop following breast implants. The FDA previously acknowledged these cancer risks in 2011, but there wasn’t enough information to define what factors increased a patient’s chances for developing cancer.

BIA-ALCL is a type of large cell lymphoma that women with breast implants have a chance of developing. It is important to emphasize that BIA-ALCL is not breast cancer. Because it is a type of non-Hodgkin’s lymphoma, it is a type of immune system cancer.

BIA-ALCL is found near the implant in the fluid and scar tissue, more often in implants with textured surfaces as opposed to smooth surfaces.. If it is not treated early there is a chance the lymphoma can spread throughout the body.

 

BIA-ALCL Data

As of last year, the FDA received 414 reports of BIA-ALCL, including the unfortunate deaths of 9 patients. The majority of these reports featured textured implant surfaces and silicone implants as opposed to smooth surfaces and saline implants.

About half of these reported cases had diagnoses within 10 years of implementation. Additionally, the FDA suggests it is “is important to note that at the time of diagnosis, patients may have their original breast implants or they may have had one or more replacements.”

 

How Can an Atlanta Personal Injury Lawyer Help?

Have you or a loved one been diagnosed with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)?  If so, please contact the attorneys at Glass & Robson today since you may be entitled to compensation. Our lawyers have gone up against some of the biggest corporations and companies in the country fighting on behalf of our clients for justice.

We are ready to help you and your family receive the compensation you deserve. Please give us a call at (404) 751-4702 or contact us online to schedule a free consultation with one of our experienced attorneys.

 

 

Sources:

AJC

FDA