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Textured Breast Implant Recall: Associated With Rare Lymphoma, FDA Warns

Allergan Textured Breast Implant Recall

Injuries: If you suffered one of the following injuries after receiving breast implants, you may have a claim for compensation:
  • tumors
  • swelling in the breast
  • breast pain
  • lumps in the breast or armpit
Litigation Status: Active
Accepting Clients: Yes
Content Author: Laurence Banville
Edited By: Emily Smith
Published: 0606/0505/17171717
Fact checked on: 0606/0505/17171717Resources Cited in this Article
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Allergan Textured Breast Implant Recall Lawsuit

The Food & Drug Administration has confirmed a link between breast implants and anaplastic large cell lymphoma, a rare form of blood cancer.

  • Breast implant-associated anaplastic large cell lymphoma
  • Most common with textured implants
  • Financial compensation may be available

Dozens of patients are now preparing to file product liability lawsuits, saying breast implant manufacturers failed to warn the public in time.

Breast implants have been linked to a rare form of non-Hodgkin’s lymphoma: anaplastic large cell lymphoma (ALCL). Experts at both the US Food & Drug Administration and World Health Organization have identified a new class of tumors that appear to develop only around breast implants.

At least nine deaths have already been attributed to this strange new type of cancer.

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Breast Implant Lawsuit: Implants May Cause Lymphoma

While this newly-identified cancer is still very uncommon, researchers at the Food & Drug Administration have now confirmed its association to breast implants. In fact, medical experts have chosen to give this form of the cancer a specific name: breast implant-associated anaplastic large cell lymphoma.

Rigorous scientific scrutiny has shown that this type of lymphoma is distinct, on the cellular level, from all other forms of the disease. To date, every documented case of these specific cancer cells has been found growing around breast implants.

Lymphoma is not breast cancer. On the contrary, the cancer linked to breast implants begins in cells of the immune system. Anaplastic large cell lymphoma primarily affects T-lymphocytes (or T-cells), a specific type of white blood cell. Medical reports suggest that cases of breast implant-associated ALCL often begin to grow in the hard capsule of scar tissue that can form around implants.

Breast Cancer Survivors Struck By New Tumors

While many women choose to get breast implants for aesthetic purposes, the procedure is also common among breast cancer survivors who have undergone mastectomy surgeries.

The tragic irony in overcoming one cancer only to develop another has not been lost on breast cancer survivors like Raylene Hollrah, who spoke to the New York Times for a recent interview. “My whole world came crumbling down again,” Hollrah told reporters. “I had spent the past six years going to the oncologist every three months trying to keep cancer away, and here was something I had put in my body to try to help me feel more like a woman, and it gave me cancer.”

Textured & Smooth Breast Implants

The breast implant’s filling appears to make no difference. Cases of breast implant-associated ALCL have been reported with both saline and silicone-filled implants. Out of 312 cancer reports that have included sufficient detail:

  • 59% – silicone gel
  • 40% – saline

The outer surface of the implant, on the other hand, seems to make a great deal of difference. The vast majority of cases have been reported in patients who have textured breast implants. While the FDA has received at least 359 reports of breast implant-associated ALCL, only 231 of those reports had information on the type of implant that had been used. Even so, the disparity between textured and smooth devices is glaring:

  • 203 cancer cases – textured implant
  • 28 cancer cases – smooth implant

This makes a lot of sense when you think about it. Smooth implants feature a slippery outer coating that doesn’t become attached to surrounding body tissue. Textured implants are rough, almost pebbled, which allows them to grab hold of body tissues. Many plastic surgeons continue to prefer textured breast implants over smooth ones. Textured implants are usually firmer, which allows the implant to hold its shape for a longer period of time. The vast majority of “shaped” (or “teardrop”) implants, which provide a more natural profile to the breast, are textured.

Breast Augmentation Grows In Popularity

Around 290,400 people underwent breast augmentation procedures in 2016, according to the American Society of Plastic Surgeons. Not all of these patients receive breast implants, however.

Newer methods of augmentation utilize the patient’s own fat reserves to artificially enhance the breasts, or reconstruct their shape after mastectomy procedures. No one is suggesting that these “fat grafting” surgeries, one of the world’s fastest-growing cosmetic procedures, bear any link to cancer.

Where breast implants are concerned, Irish medical device manufacturer Allergan leads the world market. The majority of breast implant-associated ALCL cases have involved Allergan-brand products.

Allergan Textured Breast Implant Recall: How High Is The Risk?

As we’ve already mentioned, anaplastic large cell lymphoma is very rare, accounting for about 1% of all cases of non-Hodgkin’s lymphoma (NHL). Taking current American Cancer Society statistics into account, we can estimate that around 722 Americans are diagnosed with NHL per year. Cases of breast implant-associated ALCL, for obvious reasons, are far less common.

Recent research suggests that the type of ALCL associated with textured breast implants is actually extremely uncommon. In fact, only one hundred cases of the disease have been confirmed by pathological examination in the United States. Medical device reports, submitted to the US Food & Drug Administration by doctors and patients, suggest a higher incidence, but one that still remains low. As of February 1, 2017, the FDA had received 359 reports of breast implant-associated ALCL.

The problem, though, doesn’t hinge on how high the risk of developing breast implant-associated anaplastic large cell lymphoma is, but how much having breast implants increases the risk for this form of cancer. While the risk of developing ALCL remains low, it is significantly (almost extraordinarily) higher among women with textured breast implants than members of the general population.

70-Fold Increase In Cancer Risk

In a new study, researchers at the University of Texas’ M.D. Anderson Cancer Center estimate that only around 33 out of every 1 million people with textured breast implants will develop breast implant-associated ALCL.

That probably sounds like a very low risk, because it is. But it’s far higher – 67.6 times higher – than the risk of developing normal types of breast ALCL for other people. The study continues to point out some interesting details about the people who have been diagnosed with breast implant-associated ALCL:

  • average age at diagnosis: 53
  • average time between implantation and cancer diagnosis: 10.7 years

Researchers say that the average patient will be diagnosed with breast implant-associated ALCL about 10 years after receiving their implants.

Breast implant-associated anaplastic large cell lymphoma appears to be a slow-growing tumor, according to a review of the medical literature published by the journal Plastic & Reconstructive Surgery. While several reported cases of the disease have proven aggressive, metastasizing to other internal organs quickly, the majority of tumors have been deemed “indolent” – a word used to describe cancer cells that do not immediately pose a threat. It should be noted, however, that the review in question only looked at 27 reported cases of breast implant-associated ALCL, rather than the hundred cases analysed by the team from the University of Texas.

Diagnosis & Treatment

Experts have assured breast implant patients that most cases of ALCL can be treated effectively. The lymphoma is often curable, according to the New York Times, when the symptoms are caught early. Most women have experienced symptoms like:

  • swelling in the breast
  • breast pain
  • fluid buildup around implants
  • lumps in the breast or armpit

Definitive diagnosis waits on laboratory testing. Guidelines issued by the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery advise a procedure in which fluid is drained from the lungs and tested for the presence of CD30, a protein produced by analyplastic large cell lymphoma tumors.

Treatment usually consists in removing the implant immediately, as well as the capsule of scar tissue that surrounds it. In many cases, these interventions are enough to eliminate the malignant tumor. In fact, around 85% of ALCL cases linked to breast implants have been cured through surgery alone, according to Dr. Mark Clemens, a plastic surgeon at the University of Texas. Some patients have required courses of chemotherapy or radiation therapy, Clemens says, but only after the cancer spreads beyond the breast tissue. These cases are relatively rare and generally follow long delays in diagnosis.

Breast Implant Lawsuit: Financing ALCL Treatments

Today, dozens of breast implant recipients who developed anaplastic large cell lymphoma are planning to file suit against device manufacturers. For some women, a lawsuit may be the only hope of securing compensation. Insurance companies frequently exclude cosmetic breast implant procedures from coverage – a policy that could extend even to removal procedures that become necessary after a cancer diagnosis. Several reports have already surfaced of health insurance companies refusing to pay for implant removals – even for implants that led to lymphoma.

Continue Reading: Boom Lifts: How Can A Defect Cause Workers Harm?

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