FDA Does Not Recommend Removal of Recalled Allergan Textured Breast Implants: What Are Your Rights?
As early as 2011, the FDA was aware of the possibility of patients who had breast implants using the Allergan BIO CELL Breast Implants were causing the development of a type of cancer known as anaplastic large cell lymphoma (BIA-ALCL). Over time the instances of this diagnosis grew, and in 2016, the FDA announced that there was a connection between the textured implants and the possibility of cancer. On July 24, 2019, the FDA confirmed that the textured breast implants were a cause of cancer, and they issued a mandatory recall. The Allergan company complied. If you have had a procedure for the insertion of Allergan textured breast implants it is important to contact a medical malpractice attorney at our law firm if you are beginning to experience any related symptoms of pain or discomfort in the area of the implant.
Although there is a risk of cancer with textured breast implants, the FDA is cautioning that the patient does not have to remove the implants unless there are signs of a problem. Symptoms of lymphoma that may occur with this implant can be persistent swelling or pain around the area of insertion or the presence of lumps or asymmetry ( breasts look different from each other). This would be a reason for concern, and a physician should be contacted immediately.
The FDA is continuing to evaluate the connection between the Allergan textured breast implants and cancer. They have suggested that the type of cancer is not breast cancer but is a form of non-Hodgkin’s lymphoma that attacks the immune system.
Waiting for further study and case information, the FDA does not recommend having the implant removed since the cases of lymphoma are rare. However, if there are accompanying symptoms, the implants can be removed with a more involved surgical procedure that removes the implant as well as any scar tissue that surrounds the initial insertion. They further suggest that all recipients of this implant and any others continue to see their physicians regularly to monitor any abnormal changes.
It is also a good idea to keep good records of the type and name of the implant, a record of the manufacturer, and any unique ID that establishes exactly what kind of implant was used. The surgeon who operated should have this information, but if it is not available a medical malpractice attorney at Cochran, Kroll & Associates, P.C. can research it for you.
What are your Rights?
In 2019, when the FDA recalled the Allergan textured breast implants due to the threat of cancer, there had been 572 cases of BIA-ALCL (Breast-Implant Associated Anaplastic Large Cell Lymphoma) worldwide. Of these, 481 were linked to the Allergan textured implants. Out of 33 reported deaths, 13 were connected to Allergan and other manufacturers, and 12 were traced directly to Allergan.
Currently, there are lawsuits against Allergan, and the plaintiffs are claiming that the implants do cause cancer and that the company failed to warn the women the risks of using this type of implant. These lawsuits were filed in March of 2018, and in May 0f 2019, so there is no decision or settlement at this point. If you have had a breast implant with this medical device, and you are having physical problems, then you have the option to contact a medical attorney at our law firm for a consultation.
Although the FDA has recalled the Allergan breast implant, and the company has done so willingly, there is still a question as to the medical liability the company faces regarding the women who have used this medical device. If you have used this product, Eileen Kroll, a registered nurse and a personal injury trial attorney with the Law Offices of Cochran, Kroll & Associates, P.C. is ready to assist you with your case. You can contact her at Cochranlaw.com or call 1-866-MIGH-LAW (1-866-642-4529) for a free consultation. Our law firm never charges a fee unless we resolve your case.