FDA Examines Breast Implant RisksPublished: Jul 3, 2019 in Medical Malpractice, Personal Injury, Product Liability
The U.S. Food and Drug Administration (FDA) is taking a closer look at reports of health problems linked to breast implants. Doctors and manufacturers have been dismissing these reports for years, but the number of claims of injury or illness has reached a tipping point, prompting the FDA to issue new warnings. The agency acknowledged that some patients who received implants were suffering from inflammation and tissue changes, which could lead to further health complications down the line.
Roughly 400,000 women in the United States receive breast implants each year; most procedures are cosmetic, but some women receive implants as part of reconstructive surgery after a mastectomy. The implants are silicone sacs, which can be smooth or textured, that are filled with either saltwater or silicone. Silicone-filled implants were pulled from the market in 1992, after they were linked to connective tissue diseases in patients, but they have regained popularity since their reapproval by the FDA in 2006.
As a condition of their reapproval, the FDA requires implant manufacturers to monitor patients’ health for 10 years after receiving the implants. Recently, the agency cited two manufacturers for failing to conduct these follow-up studies, putting them at risk of having their devices pulled from the market. The agency also announced that it would be holding a conference to address questions around the safety of implants and the materials used in them, due to the mounting evidence of severe health risks.
Implant Recipients Experiencing Dangerous Conditions
One of the main topics for discussion is the occurrence of anaplastic large cell lymphoma, a rare cancer infecting the immune system, among recipients of breast implants. So far, 457 women have been diagnosed with the disease, the majority of whom received implants with a textured surface. Most patients make a complete recovery after removing their implants, but some have required chemotherapy to eradicate the disease.
Breast implant illness is another serious concern, an umbrella term for numerous disorders experienced by implant recipients. These disorders often target the immune system; some patients developed connective tissue diseases, such as lupus and rheumatoid arthritis, and others experienced severe symptoms, including muscle pain and fatigue, inflammation, or cognitive dysfunction. As with anaplastic large cell lymphoma patients, some have seen a reversal of their symptoms when their implants were removed.
Patients and patient advocacy groups are relieved that the FDA is finally listening to their concerns. Painful complications from breast implants have had a serious impact on patients’ quality of life and led to chronic health conditions. According to the FDA, not enough research has been done to prove a link between the implants and these conditions, but the agency’s announcements could be a sign of change.
Edwardsville Medical Malpractice Lawyers at Cates Mahoney, LLC Fight for Victims of Breast Implant Injuries
If you or a loved one was harmed due to a breast implant, the Edwardsville medical malpractice lawyers at Cates Mahoney, LLC can help. We will thoroughly review the facts of your case to determine who is at fault for your suffering and obtain the compensation you are entitled. Located in Swansea, Illinois, we help victims of medical negligence throughout Belleville, Carbondale, East St. Louis, Granite City, Edwardsville, Chester, Waterloo, St. Louis, Madison County, St. Clair County, Monroe County, and Randolph County. Call us today at 618-277-3644 or contact us online for a free consultation.