RECALLED BREAST IMPLANTS


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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 Cancer


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 Implants 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).”
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Defective Breast Implants FAQ

Which Breast Implants have been recalled?

The BIOCELL Allergan implants have been recalled. Allergan notified the FDA that it will recall the textured breast implants and tissue expanders from the global market. All models have the same BIOCELL textured surface.

What are the symptoms of defective breast implants?

If you experience any discomfort, contact your implanting surgeon for an evaluation. 

Should I contact Allergan?

If you have been implanted with a defective product, and suffered an injury, your doctor will file a report with the FDA. You may weigh your legal options with a medical device attorney. 

What are common injuries associated with breast implants?

Breast implants are generally safe, but when they are defective they may cause infections, chronic pain, illness and BIA-ALCL in some patients. 

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The Lyon Firm confidently, professionally, and passionately advocates for injured individuals against companies due to a defective or recalled breast implants to obtain just compensation under the law.

IN RE: DEPUY ASR

METAL ON METAL HIP IMPLANTS

Nationwide Consolidation in U.S. District Court, Northern District of Ohio. The Depuy ASR Hip design was plagued with problems related to premature loosening and metallosis, caused by chromium and cobalt entering the blood stream. The resulting injuries were a result of the metal-on-metal friction inherent with the design of the product. Depuy recalled the ASR and entered into a global settlement valued at $2.5 Billion to cover an estimated 8,000 patients. The Lyon Firm represented several clients in the original settlement and continues to be active in this litigation. The settlement funds provided compensation for the revision surgeries, including compensating for medical costs, lost wages, and pain and suffering.

IN RE: BIOMET MSA MAGNUM

METAL ON METAL HIP IMPLANTS

Nationwide Consolidation in U.S District Court, Northern District of Indiana. Similar to the Depuy ASR, the Biomet metal-on-metal hip design allegedly contributed to premature hip failures and metallosis due to the metal friction. Biomet entered into a global settlement valued at $56 million to cover a few thousand claims. The Lyon Firm represented several plaintiffs in the original settlement and continues to be active in this litigation.

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