Breast Implant Lawsuits

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Potential product liability lawsuits are being evaluated against the manufacturers of certain types of breast implants, which have been linked reports of a rare form of cancer, known as breast implant anaplastic large cell lymphoma (ALCL), which is a subtype of non-Hodgkin’s lymphoma.

STATUS OF BREAST IMPLANT CANCER LAWSUITS: Lawyers provide free consultations and case evaluations for women diagnosed with anaplastic large cell lyphoma (ALCL) or other forms of breast implant cancer, which may be diagnosed years after breast augmentation or reconstructive breast surgery.


MANUFACTURERS: Allergen Inc., Mentor Corp. and others

OVERVIEW: The first breast augmentation surgery was conducted in 1962, involving a silicone breast implant. Since then, there have been questions regarding the safety and potential side effects of breast implants, including both silicone and saline implants.

Early concerns involved the risk of silicone breast implant ruptures, resulting in the removal of silicone implants from the market in 1992. They were reintroduced in 2006, after no health risks were found specifically involving silicone implants.

However, in 1997 the first case of anaplastic large cell lymphoma (ALCL) was linked to the use of a breast implant. Since then, researchers worldwide have detected dozens of cases of ALCL associated with both silicone and saline implants, resulting in a number of recent warnings from the World Health Organization, the FDA, and Australian health regulators.

All of the warnings acknowledge the risk of what is now known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which it appears may be related to textured breast implants. This breast implant cancer may surface anywhere from a few years to nearly 30 years after surgery.

A study published in October 2017 warns that reports of BIA-ALCL are likely to increase in coming months and years. Another study published at the beginning of 2018 warned that textured breast implants increased the risk of ALCL by more than 400 times.

A special report on medical devices published in late 2018 indicated that manufacturers and regulators may have known of the cancer risks, but failed to provide adequate warning to women.

In March 2019, the FDA revealed that it receives tens of thousands of breast implant adverse event reports every year.

In April 2019, all textured breast implants were banned in France, and Allergan’s Biocell breast implant was banned in Canada. French investigators also made special note of the number of cases linked to the Allergan Biocell model.

In July 2019, the FDA issued an Allergan Biocell breast implant recall, indicating nearly all cases of BIA-ALCL have been linked to that specific design. The company then removed the entire brand from the global market.

In December 2019, all federal Allergan Biocell breast implant lawsuits were consolidated before one judge for pretrial proceedings in New Jersey as part of a multi-district litigation (MDL).

Several studies, including one from February 2021, have found that removal of Allergan’s Biocell breast implants, appears to be the best way to treat BIA-ALCL.

BREAST IMPLANT LYMPHOMA: The rare form of non-Hodgkins lymphoma linked to breast implants, known as anaplastic large cell lymphoma (ALCL), occurs in the fluid surrounding the implant.

It is not a form of breast cancer, however, it can spread to the lymph nodes in some cases and has been linked a growing number of problems worldwide.

It is likely that many breast implant cancer cases have gone unreported, since most doctors remain unaware of the issue. In addition, mammograms are not useful in detecting this form of cancer, which can be found using an ultrasound and subsequent testing of fluid around the breast implant.

The FDA first issued a warning about the potential breast implant lymphoma risk in January 2011. However, at that time the agency could not confirm that the cases of ALCL in women’s breasts were definitively associated with their breast implants.

A number of studies conducted in recent years suggest a potential causal link between breast implants and ALCL cases. As a result, risk risk of breast implant-associated ALCL (BIA-ALCL) was recognized by the World Health Organization (WHO) in 2016. A number of physician groups and other countries have also issued warnings.

In March 2017, the FDA concurred with the WHO designation, indicating that at least nine deaths from breast implant ALCL have occurred in the U.S. The agency warned that the cases appeared to have a strong association with the use of textured breast implants. A year later, in March 2018, the agency reported that it had identified 400 cases of breast implant cancer.

Research has indicated that, in most cases, removing the implant cures the problem. However, in some cases it can cause solid lumps to form, resulting in the need for more traditional means of cancer treatment, such as chemotherapy.

If left undetected, the cancer can spread to the lymph nodes and can cause death.

In a warning issued by the Australian Therapeutic Goods Administration in April 2017, the risk of breast implant-ALCL was estimate to be between 1-in-1,000 and 1-in-10,000 women who have received breast augmentation or reconstructive breast surgery.

A study published by Australian researchers in May 2017 found that textured breast implants were 10 to 14 times more likely to cause BIA-ALCL than non-textured implants, with researchers determining that the higher total surface area of textured breast implants was linked to a higher risk of cancer diagnosis.

Data suggests that most cases develop between three and 14 years after a woman receives the implant. However, some cases have emerged in as little as one year after implantation, or as late as 37 years.

BREAST IMPLANT CANCER CLASS ACTION LAWSUITS: As a result of the manufacturers’ failure to thoroughly research the effects of breast implants on live tissue, which has already resulted in one past recall, and their failure to warn women about the potential risks, financial compensation may be available through a breast implant cancer lawsuit.

If warnings and information about the risk of anaplastic large cell lymphoma (ALCL) from breast implants had been provided, many women may not have chosen to undergo the procedure, and some breast implant cancer cases may have been avoided.

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  1. Charlotte Reply

    What kind of test would one have to determine if the implant was cancer?

  2. Roxane Reply

    The fluid around the implant or the capsule of the implant must be tested for CD30. This is the only way to find out. Remove your implants and make sure your capsules are removed and tested.

  3. Marie Reply

    I was just diagnosed recently with BIA ALCL. I had my Allergan implants less than 4 years. They were replacements. I developed fluid around the implant that could actually be felt. I had an ultrasound, MRI and needle aspiration of the fluid. Luckily my PET scan was negative. Does not look like cancer spread. I required a 4 hour surgery to remove implants and capsules. The implant was so adhered to my chest muscle that the Dr. had to take a small amount of muscle too. I had two drains for over two weeks after surgery. So much pain! Experience was horrifying. Surgery was April 29 and I am still recovering. Awful, awful experience.

  4. Darenda Reply

    My implants we’re double lumen, saline and silicone in one she’ll so 6 implants at one time we’re inside of me. The silicone and polyurethane leaking and ruptured into my breast tissue requiring a radical mastectomy 2017. I had a large seroma, pleural effusion, a mass behind capsule and surgeon did not test fluids nor mass nor check lymph node for symptoms of BIA ALCL I am still building up fluid in ribs and abdomen and there is no resource for diagnosis nor protocol if ALCL is not diagnosed and FDA has no guideline for this metastatic disease. I likely will die misdiagnosed. Manufacturer McGhan then Inamed now Alleghan

  5. Tammy Reply

    Please be sure to read what Mentor tried to hide at, if you haven’t already. Go to the FDA’s Maude report to get more information about Saline Smooth Implants, and ALCL, it’s not just the textured implants that cause lymphoma. There are so many women that are sick with Autoimmune Diseases including myself. If we had even known the toxic waste that the implants were made of, we wouldn’t have gotten implants. It doesn’t take a genius to know that the body will fight toxicity like that and cause Autoimmune issues. Thousands are explanting just to get these toxic bags out, and to regain some heath. It’s inconceivable that Mentor, and the FDA hid information all for the sake of money, and it’s only right that they should be held accountable.

  6. Juanita Reply

    I am the #41 patient in the world to be diagnosed with ALCL cancer. I went through 5 surgeries, chemo, lost my hair, breast removed. It was a psychology nightmare. From suicide attempts. the loss of career to breaking up my entire home. Please contact me. I would like to file suit.

  7. Stacie Reply

    I have had my Mcghan biocell textures implants 363 for 20 years now. I have noticed a small lump on my right implant. After watching the news and ads on social media I immediately checked to see if my implants were recalled. I’m afraid I may have this form of cancer. What is the first step in diagnosing it and does medical insurance cover expenses like treatment?
    I live in Honolulu Hawaii, and sometime medical attention and education of this cancer may be hard to diagnose.
    Any suggestions?
    I want to get these implants out immediately!

  8. Paula Reply

    I had cosmetic augmentation with McGhan style#468 380 saline implants behind the muscle in April of 2002. No problems at all, even getting yearly regular mammograms. However, the left implant spontaneously ruptured on Jan 6, 2020.
    I was not aware of the recall until a visit with my 4th plastic surgeon consultation last week. I read that Allergan will cover the cost of new smooth implants to replace the recalled rough textured ones but not the cost of the surgery to remove the recalled implants .This doesn’t make sense to me. And to make things worse,
    even though my implants are on the recall list, it appears that my insurance (BCBS Anthem) will only cover SILICONE ruptures that were put in for cosmetic reasons. Isn’t this absurd?
    Can this be correct? If anybody has different or more info, please advise ASAP.

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