Risks Associated with Breast ImplantsApril 24, 2019
Federal and medical advisers are urging the U.S. Food and Drug Administration (FDA) to develop a standardized, easy-to-understand consent form that clearly outlines the risks associated with breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare type of cancer that affects the immune system. Patients can review the consent form with their physician, and discuss the major risks associated with the specific type of implant that is being used. This would allow the patient to weigh the benefits versus the risks and make an informed decision.
Over the course of a two-day meeting, some panel members recommended that certain breast implant products be banned, while others discussed the lack of data about certain products. One panel member suggested that the tissue, which is removed when implants are taken out, be analyzed by a pathologist to determine the cause of the illness or complication. Another panelist suggested coming up with a definition for breast implant illness so that insurance would pay for the treatment. However, the panel did not come to an agreement that implants should be taken off the market, including the textured implants that have been known to cause cancer.
Statistics of Cancer Cases Linked to Breast Implants
According to the FDA, there are 457 known cases and nine deaths concerning BIA-ALCL in the United States. Worldwide, there are 600 cases and 17 deaths. According to the president of the National Center for Health Research, the meeting gave women the opportunity to tell their stories to the FDA panel.
Approximately 400,000 women undergo breast implant surgery every year. Seventy-five percent of patients do so for cosmetic reasons, and 25 percent are for reconstruction after breast cancer. The panel recognized the importance of monitoring patients’ implants to check for ruptures. However, as opposed to getting MRIs after three years, the panel recommended starting after six years, considering the high cost of the imaging test.
Over the course of the two-day session, committee members discussed the difficulty of making regulatory decisions due to the lack of reliable data on the negative effects of implants. For example, in studies that compared patients who had implants with patients who did not, there was a lack of control groups. Plastic surgeons argued that breast implants offer an important option for women, particularly those who have undergone mastectomies. Patients and health advocates are hoping that the FDA bans certain products, requires a black box warning on all devices, and requires doctors and patients to review and sign a checklist prior to surgery.
Baltimore Medical Malpractice Lawyers at LeViness, Tolzman & Hamilton Represent Victims of Breast Implant Complications
If you had breast implants and were not warned about the complications, including the risk of BIA-ALCL, you are urged to contact the Baltimore medical malpractice lawyers at LeViness, Tolzman & Hamilton. We will conduct a thorough review of your case and determine whether your healthcare professional failed to discuss the risks associated with breast implants. Our dedicated legal team will secure the maximum financial compensation you deserve. To schedule a free, confidential consultation, call us today at 800-547-4LAW (4529) or contact us online.
Our offices are located in Baltimore, Columbia, Glen Burnie, and Towson, allowing us to represent medical malpractice victims in Maryland, including those in Anne Arundel County, Baltimore County, Carroll County, Harford County, Howard County, Montgomery County, Maryland’s Western Counties, Prince George’s County, Queen Anne’s County, Southern Maryland, and the Eastern Shore, as well as the communities of Catonsville, Essex, Halethorpe, Middle River, Rosedale, Gwynn Oak, Brooklandville, Dundalk, Pikesville, Nottingham, Windsor Mill, Lutherville, Timonium, Sparrows Point, Ridgewood, and Elkridge.