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Breast implant patients are now planning to file lawsuits, after experts at the World Health Organization and Food & Drug Administration confirm an association between breast augmentation and rare cases of non-Hodgkin’s lymphoma.
Our experienced product liability attorneys can help. Call today and speak with a textured breast implant recall lawyer for a free legal consultation – at no charge and no obligation.
Did you see a TV commercial alerting women with breast implants and their families to a potential risk for lymphoma? Many of these ads, which usually run on local television stations, note that breast augmentation devices, especially textured implants, have now been linked to a rare type of non-Hodgkin’s lymphoma, known as anaplastic large cell lymphoma.
Both the World Health Organization and US Food & Drug Administration have confirmed the association between breast implants and anaplastic large cell lymphoma, a form of immune system cancer.
Recent studies suggest that women with breast implants may be up to 67 times more likely to develop this rare cancer than members of the general population.
While no causal explanation has yet been proven, health experts have gone so far as to define lymphoma cases that develop with breast implants as a new form of cancer, dubbing the tumor breast implant-associated anaplastic large cell lymphoma.
Anaplastic large cell lymphoma (ALCL) is extremely rare, even in patients who have undergone breast augmentation procedures. To date, only around 360 patients have stepped forward to report their diagnoses to the FDA, although the true number of cases is likely higher.
Even so, the risk remains low. Experts in the United States estimate that about 33 people out of 1 million with textured breast implants will eventually show signs of the disease. Researchers outside the US, however, have calculated very different risks. A report from Australia’s Therapeutic Goods Administration, which has now identified 53 cases of the disease and at least three related deaths, says the incidence could by anywhere from 1-in-1,000 to 1-in-10,000 among patients with breast implants. Why the US estimate is one-third of the Australian number is unclear.
To complicate matters, this form of lymphoma appears to have a relatively long latency period. Most patients have only been diagnosed after 10 to 11 years after initially receiving their breast implants.
The disease is far more prevalent in patients who have received textured breast implants. Only a small number of cases, around 12%, have been reported in women with smooth implants. France’s health regulatory agency, the National Agency for Medicines and Health Products Safety, has asked companies that make textured implants to complete bio-compatibility studies. Hopefully, these tests will provide more information on how human breast tissue is affected by textured implants.
Some experts have suggested that the pebbly or rough outer coating of textured implants may irritate underlying tissue, eventually leading to abnormal cell growth. Another theory holds that textured breast implants provide a breeding ground for bacteria, which could cause chronic inflammation and over-zealous immune system responses.
Device materials or production methods may also be contributing factors. Breast implants manufactured by Allergan, the world leader in breast augmentation, have been linked to more cases of lymphoma than any other brand.
The company uses a unique method to produce its implants, rolling them in salt to create a rough surface before washing the salt off. This “lost-salt” technique provides Allergan’s textured implants with deeper nooks and crannies than other models, but could provide more surface area for bacterial growth.
Breast implant-associated ALCL is most often characterized by troubling symptoms, but unfortunately, many of these signs can easily be mistaken for the effects of benign conditions. The most common symptoms, according to the FDA, are persistent swelling and / or pain near the implant. In limited cases, patients have also reported:
Subsequent clinical examinations have also found evidence of seroma, a buildup of fluid around the implant. Researchers have tapped this fluid as the definitive indicator of the cancer’s presence. After extracting a sample, doctors can test the accumulated fluids for signs of CD30 (or TNFRSF8), a protein believed to be produced by anaplastic large cell lymphoma cells.
The current medical literature shows that most breast implant-associated ALCL tumors are discovered growing very close to the breast implant, surrounded by a capsular contracture.
The cancer cells do not grow in breast tissue, but in seroma fluid or in the scar tissue surrounding a breast implant. This is not breast cancer. It’s a distinct form of non-Hodgkin’s lymphoma, a category of diseases that begin in cells of the immune system. Technically, breast implant-associated ALCL appears to be a form of T-cell lymphoma. In this class of diseases, a specific type of white blood cell, known as T-lymphocytes, begin to grow and multiply out of control. T-cell lymphomas account for around 15% of all non-Hodgkin’s lymphoma cases diagnosed in the United States.
Yes.
Patients have cause for hope. Breast implant-associated ALCL responds well to treatment. In fact, many experts consider the disease “entirely curable.” As the cancer’s latency period suggests, ALCL grows slowly; in most cases, it is not aggressive.
While metastatic forms of the disease have been reported, the cancer is likely to spread only after lengthy delays in diagnosis. It’s extremely important that patients with breast implants who experience any of the symptoms we described above seek medical treatment immediately.
Most of the documented cases have been treated with surgery alone. Plastic surgeons, like Dr. Mark Clemens at the University of Texas’ M.D. Anderson Cancer Center, have found success by removing a patient’s breast implants, along with the hard capsule of scar tissue that can form around the devices. In fact, around 85% of cases are cured exclusively through surgical means, Dr. Clemens told the New York Times. Rare are the cases in which chemotherapy or radiation treatments become necessary to kill off spreading cancer cells.
Breast implant-associated ALCL is marked, not only by the physical rigors imposed on patients, but by psychological traumas, as well. The medical community relies on breast implants for two primary purposes: aesthetic procedures and reconstructive surgeries, which many women receive after undergoing mastectomy operations to remove cancer. Tragically, some patients have overcome breast cancer only to be diagnosed with breast implant-associated ALCL years later.
Dozens of women who were diagnosed with breast implant-associated anaplastic large cell lymphoma are now preparing to file product liability lawsuits, hoping to hold implant manufacturers like Allergan financially responsible for their illness. Financial compensation may be available.
Our experienced attorneys are offering free consultations, so you can find out more about your options at no charge. Just call today or fill out our contact to speak with a lawyer now.
FDA: Questions and Answers About BIA-ALCL
American Society of Hematology: 2016 WHO Revisions
