Breast Implant ALCL Lymphoma
Breast Implant ALCL Lymphoma Side Effects Could Lead To Cancer Lawsuits
Are you a breast implant recipient whose been diagnosed with lymphoma? The U.S. Food & Drug Administration (FDA) warned that some breast implants may be associated with anaplastic large cell lymphoma (ALCL), a rare form of cancer.
Our breast implant lymphoma lawyers are investigating this association and are offering free lawsuit evaluations to victims of this cancer. I If you or someone you know has been injured or died due to anaplastic large-cell lymphoma associated with breast implants, the attorneys at Parker Waichman would like to hear from you. You may be entitled to compensation for your medical bills, lost wages, pain and suffering, and other damages. We urge you to contact one of our breast implant lymphoma lawyers today to protect your legal rights.
Breast Implants Tied to Rare Cancer Associated with Hundreds of Injuries and Nine Deaths
As of February 1, 2017, the FDA received 359 reports of a rare cancer tied to breast implants. According to The New York Times, the cancer was first associated with breast implants in 2011. To date, there have been nine deaths tied to the implants, the FDA indicated in March 2017.
According to the agency, the deaths were not the result of breast cancer, but rather, a rare malignancy of the immune system know as anaplastic large-cell lymphoma (ALCL). In the cancer cases associated with the breast implants, the rare cancer grows in the breast, typically in the capsule of scar tissue that forms around an implant, wrote The New York Times, noting that the cancer is often treatable and not deadly.
The issue surrounding anaplastic large-cell lymphoma and breast implants is likelier to occur with textured implants compared rather than smooth implants. The textured implant has what The New York Times describes as a pebbly surface, according to the agency.
Of the 359 reported cases, 231 involved implants in which information about the implant surface was accessible: 203 were textured; 28 were smooth. According to The New York Times, the implant contents were not as critical. Of the 312 cases in which the contents were known, 186 were filled with silicone gel and 126 were filled with saline. Cases were typically discovered following the development of symptoms including lumps, pain, fluid buildup, and swelling. In many cases when lymphoma occurs, removing the implant and surrounding tissue eliminates the disease; however, some women may need to undergo chemotherapy and radiation.
The agency indicated that it is not possible to know how many cases exist given limited reporting of problems and a lack of global implant sales data. What is known as of March 2016 is that approximately 290,000 women in the United States received implants for breast enlargement in 2016; 109,000 women received the implants for reconstruction after breast cancer, according to the American Society of Plastic Surgeons, The New York Times reported.
The difference in risk regarding the difference in implant surfaces does not provide an explanation concerning the increased risk; however, the body does react differently to the textured implant than to the smooth implant, according to Dr. Alex K. Wong, a plastic surgeon and researcher at the University of Southern California's Keck School of Medicine. It seems that tissue grows into the microscopic grooves in the textured implants, The New York Times pointed out. "When we take these out, you can hear a peeling sound," Dr. Wong said. "Whereas with a smooth implant, it's like Jell-O. You can spin it around. It moves really easily." Studies in rats in Dr. Wong's laboratory revealed different levels of genetic activity in the animals' tissues responded to smooth versus textured breast implants. "We're still trying to find out why the surface matters," he said, noting that, in some cases the cancer seems to also be tied with a certain bacterial infection. The name of that infection was not provided.
According to The New York Times, surgeons use the textured implants when they desire to have the implant remain in place without moving, which is needed for the newer, anatomically shaped implants that would be less attractive if they were to shift or flip upside down. According to the FDA, physicians should consider the potential of lymphoma in those women who began experiencing breast problems a long time following implant surgery. If a woman with breast implants does not have any symptoms, the FDA recommends leaving the implants in place; however, women receiving implants should be advised of the potential problem and the increased risk associated with textured implants.
Stephanie Caccomo, FDA spokeswoman, announced in March 2016 that "in 2016, there were several advances in the description of the disease and treatment recommendations, including recognition of the disease by the World Health Organization and publication of diagnosis and treatment guidelines by the Plastic Surgery Foundation and National Comprehensive Cancer Network," The New York Times reported.
"All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants," the FDA wrote in a statement, according to CNBC. "Most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation," the agency added.
CNBC pointed out that breast augmentation is the second most popular cosmetic procedure in in the United States; liposection is the first most popular cosmetic procedure. More than 300,000 breast augmentation procedures were performed in 2015.
Suspicions were rising that breast implants might lead to ALCL, a type of non-Hodgkin's lymphoma. The FDA first began researching the possibility in 2011. "At that time, the FDA knew of so few cases of this disease that it was not possible to determine what factors increased the risk," according to the FDA. Today, there is more information, including hundreds of complaints and a World Health Organization (WHO) report indicating that breast implants as a potential cause.
"As of February 1, 2017, the FDA has received a total of 359 medical device reports of breast-implant-associated ALCL, including nine deaths," according to the FDA. "Breast implants approved in the U.S. can be filled with either saline or with silicone gel. They come in different sizes and shapes and have either smooth or textured surfaces (shells)," the agency added.
The cancer may take approximately10 years to appear after the implant is first brought into the body and typically remains in the area surround the implant, WHO researchers reported in 2016 in the journal Blood. Nevertheless, there is a chance that the cancer may leak out and spread, according to CNBC.
The FDA recommends that patients do some research before receiving breast implants, noted CNBC. "Although it is rare, breast-implant-associated ALCL appears to develop more frequently in women with textured implants than in women with smooth-surfaced implants. Before getting breast implants, make sure to talk to your health care provider about the benefits and risks of textured-surface vs. smooth-surfaced implants," the FDA wrote. "If you have breast implants, there is no need to change your routine medical care and follow-up…. Follow your doctor's instructions on how to monitor your breast implants. If you notice any changes, contact your health care provider promptly to schedule an appointment. Get routine mammography screening and ask for a technologist specifically trained in performing mammograms on patients with breast implants," the FDA advised. People implanted with silicone gel implants are recommended to get magnetic resonance imaging (MRI) scans to search for leaks, according to CNBC.
The American Society of Plastic Surgeons and the Plastic Surgery Foundation are making a list of implant patients who develop ALCL. "The research will also focus on identifying potential risk factors and criteria detection and management of this disease," the groups indicated on a website devoted to the matter.
In 2011, the FDA reported that, one in five women with silicone breast implants for cosmetic purposes-and half of those who received implants after a mastectomy-required surgery to remove the implants within ten years.
Breast Implant Lymphoma: Previous Background
In January 2011, the FDA advised that women who had received breast implants should notify their doctors of any changes in their breasts because of a possible association with a rare type of lymphoma. In breast implant patients, ALCL has occurred in the scar capsule adjacent to the implant. Symptoms of breast implant lymphoma include:
- Asymmetry that developed after their initial surgical sites were fully healed
These symptoms were due to collection of fluid (peri-implant seroma), hardening of breast area around the implant (capsular contracture), or masses surrounding the breast implant. Examination of the fluid and capsule surrounding the breast implant led to the ALCL diagnosis, the FDA indicated.
ALCL is a rare malignant tumor (non-Hodgkin lymphoma) that may appear in several parts of the body including the lymph nodes, skin, bones, soft tissue, lungs or liver. Each year ALCL is diagnosed in about 1 out of 500,000 women in the United States. ALCL located in breast tissue is found in only about 3 out of every 100 million women nationwide without breast implants.
The FDA notification was based on a review of scientific literature published between January 1997 and May 2010 and information from other international regulators, scientists, and breast implant manufacturers. At that time, the literature review identified 34 unique cases of ALCL in women with both saline and silicone breast implants.
In total, the FDA was than aware of about 60 cases of ALCL in women with breast implants worldwide. The agency indicated that the number was difficult to verify because not all cases were published in scientific literature and some reports may be duplicate s. The FDA is requesting that health care professionals report any confirmed cases of ALCL in women with breast implants.
The FDA indicated that it is working with breast implant manufacturers to update their product labeling to address the lymphoma risk. The agency recommended that health care professionals and women pay close attention to breast implants. Breast implant recipients should contact their doctor if they notice any changes, and women considering breast implants should discuss the risk of ALCL with their doctors.
Legal Help for Victims of Breast Implant Lymphoma
If you or someone you know was diagnosed with lymphoma related to breast implants, you may have valuable legal rights. To discuss your case with one of our breast implant lymphoma lawyers, please fill out our online form, or call 1-800-YOURLAWYER (1-800-968-7529) today.