Textured Breast Implant Lawsuits

If you received textured breast implants, you may be at increased risk of developing a specific type of cancer known as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA ALCL), according to a July 24, 2019 safety announcement from the U.S. Food and Drug Administration. So far, there have been at least 573 textured breast plant recipients diagnosed, and 33 have died from the disease. Of the 573 cases, 481 are attributed to Allergan-manufactured implants, prompting a massive worldwide breast implant recall.

Women who have received textured breast implants, but have had no symptoms do not necessarily need them removed, but the possibility of developing a life-threatening condition should be discussed with their health care practitioners. If you have been suffering from adverse side effects, then you may benefit from a free consultation with Bart Bernard, a medical device lawyer handling cases from all over the U.S.

Primary Complications

The most worrisome complication of Allergan textured breast implants is the potential of developing a rare, but slow-moving cancer of the immune system known as Breast Implant Associated Anaplastic Large Cell Lymphoma. Fewer than 10 patients per year are diagnosed with BIA-ALCL, but with some 550,000 textured implants placed each year, we are likely to see many more cases emerge in the coming years.

It is not known why textured implants are linked with this type of cancer, but researchers have posited that the inflammation resulting in the formation of scar tissue that holds the implants in place may have something to do with it. It is also possible that bacterial contamination at the surgical site, allergic reaction to implant particles, and familial history of lymphoma are factors. 

Symptoms of breast implant cancer can surface anywhere from two to 30 years after breast augmentation or reconstruction surgery. The average patient finds complications after eight years.

Early symptoms of BIA ALCL include some or all of the following:

  • Painless, but noticeable swelling in the lymph nodes of the armpit, neck, or breast
  • Excessive fluid buildup surrounding the implant’s location
  • Persistent redness, skin rash, and pain in the breast area
  • Loss of appetite, chronic fatigue, fever, night sweats, and back pain
  • Asymmetry and persistent swelling once the surgical incision has healed

For an accurate diagnosis, one of the enlarged lymph nodes is biopsied to determine whether lymphoma cells are present. With early detection, BIA-ALCL can be treated by removing the implant and surrounding scar tissue. However, like so many other cancers, ALCL can metastasize to other parts of the body, with chemotherapy and radiation treatment required.

In addition to breast implant cancer, many women with textured breast implants have also reported breast implant illness. Adverse reactions following breast implants include:

  • Chest pain
  • Chills
  • Depression
  • Fatigue
  • Fibromyalgia pain
  • Hair loss
  • Headaches
  • Hormonal disturbances
  • Insomnia
  • Light sensitivity
  • Neurological problems
  • Rash

Shortly after placement, some textured breast implant recipients have gone on to be diagnosed with arthritis, connective tissue disease, fibromyalgia, Hashimoto’s thyroiditis, Multiple Sclerosis, sarcoidosis, scleroderma, Sjögren’s Syndrome, or cancers of the brain, cervix, lungs, respiratory tract, and vulva.

If you are experiencing serious breast implant illness symptoms such as cancer, contact a qualified attorney to see if you are eligible to pursue a claim for damages.

FDA History of Actions & Recalls Related To Textured Implants and Lymphoma

The link between textured implants and lymphoma was first identified in 1997, according to the Washington Post, but it may have seemed like an outlier case since the cancer was so rare. It wasn’t until 2011 that the FDA took notice and issued an alert that they were aware of 60 cases of implant-associated lymphoma.

At that point, most doctors had never heard of the ALCL risk, so it’s likely there were more cases that just weren’t reported. On top of that, manufacturers buried warnings amid a laundry list of “possible complications,” with little effort to explore the cause-and-effect or provide more specific guidance to health care practitioners.

It wasn’t until 2016 that the World Health Organization provided the official designation that linked textured implants and lymphoma. In 2017, the FDA announced they agreed with the designation and had, in fact, received 359 medical device reports involving breast implants and lymphoma.

On July 24, 2019, the FDA prompted a recall of the following textured breast implants:

  • Natrelle Saline breast implant styles 168, 363, 468
  • Natrelle and McGhan 410 LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
  • Natrelle and McGhan 410 Soft Touch LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
  • Natrelle 510 Dual-Gel LX, MX, FX
  • Natrelle and McGhan Round Gel 110, 110 Soft Touch, 120, 120 Soft Touch
  • Natrelle Komuro KML, KMM, KLL, and KLM
  • Natrelle Ritz Princess RML, RMM, RFL, RFM
  • Natrelle 150 Full Height and Short Height double lumen implants
  • Natrelle 133 tissue expanders with/without suture tabs 133FV, 133MV, 133LV, 133MX, 133SX, 133SV, T-133FV, T-133MV, T-133LV, T-133MX, T-133SX, T-133SV, 133FV-T, 133MV-T, 133LV-T, 133MX-T, 133SX-T, 133SV-TNatrelle 133 Plus tissue expander styles 133P-FV, 133P-MV, 133P-LV, 133P-MX, 133P-SX, 133P-SV, T-133P-FV, T-133P-MV, T-133P-LV, T-133P-MX, T-133P-SX, T-133P-SV, 133P-FV-T, 133P-MV-T, 133P-LV-T, 133P-MX-T, 133P-SX-T, 133P-SV-T

The US breast implant recall does not include Allergan’s NATRELLE® smooth or MICROCELL® breast implants and tissue expanders.

Textured Breast Implant Manufacturers

Only about 10% of breast implants sold in the U.S. are considered the “textured” variety. The biggest manufacturer has been Allergan, a medical device firm headquartered in Dublin with a U.S. footprint in New Jersey. Allergan has been the target of many breast implant lawsuits so far.

While Allergan may be the most commonly implicated brand due to its huge market share, other manufacturers may also face lawsuits. Many of the reports of textured breast implants problems were allegedly under-coded, lacking information on which manufacturer provided the implant.

Other manufacturers of textured breast implants who may be named in suits over the coming years include:

  • Mentor (Johnson & Johnson) – rapidly picking up market share
  • Sientra – accounts for about 50% of market share
  • AirXpanders – filed for bankruptcy after a safety review and market suspension in Australia
  • Establishment Labs (Motiva implants) – growing to outpace Sientra overseas

The FDA has issued warning letters to both Sientra and Mentor regarding inadequacies in their post-approval studies.

Multidistrict Litigation

Textured breast implant lawsuits are in the early stages now, but in November 2019, plaintiffs in several pending class actions made a motion before the Judicial Panel on Multidistrict Litigation to centralize Allergan breast implant lawsuits in United States District courts for the Middle District of Tennessee or the Central District of California. Allergan prefers to deal with the suits on their home turf of New Jersey.

MDL procedures would consolidate pre-trial discovery of all qualifying cases in federal district courts. A series of early trials would explore common strengths and weaknesses of the central argument in front of the same judge before remanding the following cases back to the courts where they were originally filed for individual consideration.

In that way, MDL cases are different from class actions; plaintiffs are granted settlements or jury awards based on the unique facts of the individual claims. Even so, centralizing similar cases into MDL greatly expedites the entire process.

Allergan Lawsuit Settlement Amounts and Jury Awards

There have been no settlements or jury awards associated with textured breast implant cancer, as of November 2019. If the past is any indicator of the future, we are likely to see landmark settlement and jury award amounts. In 1994, three breast implant manufacturers – Dow Corning, Bristol-Myers Squibb, and Baxter Healthcare – agreed to set aside $3.7 billion to resolve more than 25,000 claims that their silicone breast implants seriously injured women. At the time, it was the largest class-action settlement in history.

If you have any questions about textured breast implants and lymphoma, contact Bart Bernard to begin exploring your legal options. Initial consultations are always free, and you pay nothing at all unless we recover compensation on your behalf. Call The People’s Trial Lawyer™ today!

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