Breast Implant Lymphoma Risks Investigated by Medical experts and product liability lawyers

The U.S. Food and Drug Administration (FDA) recently issued a report about the risk for anaplastic large-cell lymphoma in women with breast implants. The FDA issued the alert, noting that almost all cases of implant-caused lymphoma have involved implants with textured rather than smooth surfaces. The implant texturing, which is used to help anchor the implants, is said to cause constant inflammation, and later lead to cancer.

Of the 359 global cases of breast implant-caused cancer reported to the FDA, there have been at least 12 deaths. The cancer and death toll is likely much higher, as the statistics only rely on voluntary reports from patients and doctors.

The FDA said they have known about this rare cancer occurrence since 2011, and have since strengthened their understanding of the condition. The World Health Organization (WHO) has also expressed concern over breast implant-associated T-cell lymphoma that can develop following breast implants.

Allergan has recalled textured breast implants due to added BIA-ALCL risk. 

Joe Lyon is a highly-rated Cincinnati product liability lawyer representing plaintiffs nationwide in a wide variety of civil litigation claims.  

Textured Breast Implants a Serious Risk to Women

Roughly 400,000 women receive breast implants each year in the United States. An estimated one in 30,000 women with textured implants will develop the cancer. The material of the implant—silicone or saline—has not been found to affect one’s risk. The cancers from textured implants have been diagnosed anywhere from two to 28 years after implantation, with a median diagnosis of eight years.

As breast implants have gained in popularity over the years, medical experts fear the breast implants lymphoma risk could encompass thousands of women across the country. In the years 2000 to 2016, the number of breast augmentation surgery rose 37 percent in America.

The FDA first learned of the risk in 2011 and implant product labeling was added. The label warnings on Allergan and Mentor implant packaging however, are listed among several other less severe complications and can get lost in the small print.

Implanting surgeons are encouraged to warn patients of the breast implant lymphoma risk, but it is estimated that only around 30 percent of doctors discus the risk of cancer with patients.

FDA Breast Implant Warnings

The FDA has proposed a risk assessment checklist and boxed warning after hundreds of reported cancer cases came to the attention of the agency. Many patients say they had clue there were risks associated with implants before having surgery.

The FDA wants a boxed warning that tells patients that breast implants do not last a lifetime, and that the chances of developing complications increase the longer they have the implants. The warnings should also highlight the link to anaplastic large cell lymphoma, and describe some symptoms of cancer patients should be aware of.

The checklist could warning women that if they smoke or have diabetes or autoimmune disease, they may have additional risks after surgery, including chronic pain or loss of sensation.

What is Lymphoma?

Lymphoma is a common cancer of the blood—the two main forms of lymphoma being Hodgkin lymphoma and non-Hodgkin lymphoma. Lymphoma occurs when cells of the immune system, types of white blood cells, multiply uncontrollably.

It is not known entirely why breast implants cause T-cell lymphoma in the breast, though some medical professionals surmise that bacteria attached to the textured implant creates an immune system reaction within the body of a woman.

Symptoms of this rare form of lymphoma include, pain, a swelling around the breast and a buildup of fluid around implants. If detected early on, the cancer is generally treatable.

Affected patients are encouraged to remove their implants immediately along with the other damaged tissue in the breast. About 85 percent of cases are resolved after surgery. If the cancer has spread, however, chemotherapy and radiation may be necessary.

Breast Implant Health & Cancer Risks

The FDA recommends that women consider a few things before undergoing breast implant or breast augmentation surgery, including:

  • Breast implants are not meant to be left inside the body forever, and the longer implants they remain in the body, the more likely the need to have them removed.
  • Additional surgeries and revision surgery is likely because breast implants are not lifelong devices and complications occur frequently.
  • Breast implant removal or replacement may not be covered by individual insurance plans.
  • Some breast implant models have been recalled after being deemed defective.
  • The longer breast implants remain, the more likely you are to develop related complications and cancers, which may be irreversible.
  • Breast implant complications may include capsular contracture, implant removal, rupture or deflation, asymmetry, scarring, pain, and infection.
  • Patients should read the product labeling and other educational materials carefully and discuss any questions you have with your surgeon.
  • If you have breast implants removed, you may experience changes to your natural breasts and undesirable cosmetic changes.
  • Breast implants need to be monitored, and some doctors recommend magnetic resonance imaging (MRI) or ultrasound tests to screen for breast implant rupture and other complications.
  • If you notice any unusual changes in your breasts or implants, contact your surgeon or health care provider as soon as possible.
  • There is a risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in the breast or scar tissue surrounding the implant. There is a risk of death for patients diagnosed with BIA-ALCL.
  • Breast implant patients report symptoms such as chronic fatigue, brain fog, joint and muscle pain, which has been described as “breast implant illness (BII).”

Allergan Breast Implant Recall

In 2019, the FDA requested that Allergan recall their BIOCELL textured breast implants and tissue expanders marketed in the U.S. due to risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare cancer of the immune system.

FDA analysis concluded that the risk of BIA-ALCL with Allergan BIOCELL textured implants is around six times the risk of BIA-ALCL from other manufacturers.

Of over 550 worldwide reported total cases of BIA-ALCL, 481 patients are reported to have Allergan breast implants at the time of diagnosis. AT least twelve deaths occurred in patients implanted with an Allergan breast implant at the time of their lymphoma cancer diagnosis.

Allergan Natrelle 133 and 133 Plus tissue expanders have not yet been associated with BIA-ALCL, but the devices have the same Biocell texture, which is why they were recalled. Tissue expanders are only indicated to be used for 6 months maximum, but experts do not know what duration of exposure to the Biocell texture may lead to cancer.

Legal Action for Breast Implant Lymphoma Victims

Experienced medical device attorneys are now filing claims against implant makers like Allergan and Mentor for manufacturing defective products that have not been properly tested long term, and cause deadly diseases like cancer. The companies producing implants that cause cancer must be held responsible for the damage they cause.

Thus far, not many implants have been recalled. As seen in the past from many medical device corporations, legal action is the only deterrent to putting defective devices to market, and the only way to protect consumers from further injury.

The Lyon Firm specializes in representing plaintiffs in product liability and personal injury lawsuits, filed against negligent medical device companies to recover rightful compensation.

If you or a loved one has developed lymphoma after receiving breast implants, and have questions about the legal remedies available to improve quality of life and medical care, contact The Lyon Firm at (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer critical questions regarding the breast implant lymphoma lawsuits.