Product Liability lawyer and Ohio medical device recall attorney reviewing Allgeran breast implant recall cases and BIA-ALCL lawsuits for plaintiffs nationwide
The FDA has recently ordered Allergan to issue to a textured breast implant recall in the U.S market. The recall includes tissue expanders, and is due to evidence of an increased risk of BIA-ALCL, or Breast Implant-Associated Anaplastic Large Cell Lymphoma.
The FDA (U.S. Food and Drug Administration) requested that the Allergan recall include all BIOCELL textured breast implants and tissue expanders currently marketed. Worldwide Medical Device Reports (MDRs) have indicated an increasing number of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) cases and related deaths, which are closely associated with the breast implants. At least 573 cases of anaplastic large cell lymphoma related to breast implants have been reported to the FDA, along with 33 patient deaths.
The FDA says the risk of BIA-ALCL with Allergan BIOCELL textured implants is around 6 times the risk of BIA-ALCL with other textured implants on the market. Macro-textured implants, like the kind being recalled, represent less than 5 percent of all breast implants in the United States. The recalled textured breast implant products include:
Joe Lyon is a highly-rated product liability lawyer and Ohio medical device lawyer who has successfully represented individuals throughout the country in complex product liability litigation. The Lyon Firm works with medical experts to determine the cause of BIA-ALCL textured breast implant cancer.
To be clear, BIA-ALCL is not breast cancer, but rather a far less common form of non-Hodgkin’s lymphoma. BIA-ALCL is commonly found in the scar tissue and fluid near breast implants, and can potentially spread to other parts of the body.
If not diagnosed and treated promptly, patients may suffer from complications and severe cancer-related conditions, including death. Patients are encouraged to speak to their implanting surgeon and a product liability attorney.
Even though the overall chance of developing BIA-ALCL is low, the Allergan textured breast implant recall indicates the serious nature of potential related health problems. Allergan has said they are taking precaution due to recent reports of an increased cancer risk. Tens of thousands of women have been implanted with such devices over the years and may be at risk.
Doctors and the FDA have urged women to consider a number of health risks before deciding on breast implants. There may be safer ways to protect yourself against breast implant lymphoma, and may discuss with your doctor.
Any women who have developed lymphoma or another cancer due to defective breast implants can contact a medical device recall attorney to discuss your legal options. Settlements and awards are likely following any injury caused by a defective medical device.
The FDA first identified a possible association between breast implants and BIA-ALCL in 2011. Any patient experiencing cancer symptoms or changes should talk to their doctor.
The primary symptoms of BIA-ALCL are inflammation and pain in the implant area. Symptoms may present years after implantation or relatively soon after the implant was placed.
The FDA and Allergan will continue to monitor BIA-ALCL cases linked to textured breast implants and tissue expanders. The FDA also announced recommendations for label changes for breast implants to include a boxed warning indicating specific risks. According to the American Society of Plastic Surgeons, breast augmentation was the most popular cosmetic surgical procedure performed in 2018.
Millions of women have breast implants, silicone sacks filled with saltwater or silicone gel that are used to enlarge the breasts for cosmetic reasons or for reconstruction after a mastectomy. Over 310,000 breast augmentations were performed in 2018 alone.
But thousands of women with breast implants have reported developing cancers and other illnesses, including several symptoms some experts call “breast implant illness.” Some of the illnesses resemble connective tissue disease like lupus, rheumatoid arthritis and other serious autoimmune conditions.
Most women with breast implants have no serious complications, but as many as 20 percent of women with implants have their implants removed within 10 years, usually due to complications. Doctors have said implants are not meant to be lifetime devices.
The FDA would like implant manufacturers to list the ingredients in implants, as reports of heavy metals have been concerning in the devices. Metals may include mercury, lead, arsenic and platinum, and dangerous chemicals. New implant screening recommendations for those who already have silicone gel implants say women should undergo imaging scans to look for ruptures beginning five years after the surgery.
Boxed warnings are the strongest form of warning required by the FDA for product labeling. The FDA suggests warnings that may include: “breast implants are not considered lifetime devices,” and “breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma.”
The proposed guidance offers recommendations to help ensure women have access cancer risks and other health risks. When the FDA guidance is finalized and submitted, manufacturers may choose to follow the recommendations or they may choose other labeling as long as the labeling complies with FDA laws and regulations.
If you or a loved one has suffered from BIA-ALCL cancer or another implant complication and have questions about the legal remedies available to improve quality of life and medical care in Ohio, 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 Allergan breast implant recall.