Extremely Rare T-Cell Lymphoma Tied to Breast Implants

 
Category: 
Defective Medical Devices
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Breast Implants

By Sean Lally, Staff Writer

Many people have heard of breast implants, but fewer have heard of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a form of non-Hodgkins Lymphoma that to-date remains extremely rare. The FDA first discovered an association between breast implants and ALCL in 2011 and since then the agency has been engaged in an effort to learn more about this rare disease. A report published in January of 2011 called for a concerted effort to obtain data pertaining to the issue. To that end, the FDA collaborated with the American Society of Plastic Surgeons (ASPS) to develop a registry to facilitate the collection of pertinent information and to create a more comprehensive list of patients suffering from this affliction.

Research Developments

Since 2016, the World Health Organization and the FDA have regarded BIA-ALCL as a rare T-cell lymphoma. As noted by Kirtland & Packard, LLP, this type of disease can result in uneven breast size, swelling, lumps and associated pain. According to the FDA, people with smooth devices are less likely to contract BIA-ALCL than those with rougher, textured implants. In June 2016, the French National Agency for Medicines and Health Products Safety (ANSM) asked manufacturers to report information regarding the “biocompatibility” of textured implants, to better understand the associations between non-smooth devices and BIA-ALCL. Earlier this year, the FDA analyzed reports on 359 implants linked to BIA-ALCL. Of those 359 reports, 231 contained information regarding the nature of the device. And just over 200 of those reports indicated that implants associated with the disease were textured.

Treatments

BIA-ALCL can be treated in a few different ways. In many cases, doctors will surgically extract both the implant and the capsule enveloping the implant – this latter is known as a capsulectomy. In other cases, patients suffering from this horrific disease will undergo radiation and chemotherapy. When the disease exists solely in the capsule, patients are far more likely to overcome the sickness, but if a lump emerges in the breast, the chances for remission diminish and aggressive treatment becomes necessary, according to a study published in 2013.

Product Liability

In the unfortunate case that you or a loved one has contracted BIA-ALCL after having breast implant surgery, you may want to pursue compensation for damages incurred by the device. You might be able to obtain recompense by way of a product liability lawsuit. However, it should be stated, such a course of action involves numerous complexities.

Proof

To begin with, in order to successfully obtain remuneration in a product liability suit, you must be able to prove that you or a loved one has a manifest injury with physical symptoms. You must also show that this physical injury is directly linked to the product and that you were using the product in the proper manner, as dictated by the manufacturer.

Type of Defect

Once you successfully collect the above proof, you then have to determine the way in which the product was defective. For instance, you may want to argue that the product (in the case the implant) was defective in terms of its design and not defective because of a mistake in the manufacturing process. Or perhaps, there wasn’t a satisfactory warning label informing you of the dangers associated with the product.

In order to choose the optimal path, you should schedule a consultation with a product liability attorney, ideally one with knowledge of BIA-ALCL. He or she will be of major help in sorting out this complicated and emotionally charged issue. 

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