Concerns over breast implants have been rising, especially since reports confirmed a link between certain textured saline and silicone-filled implants (and textured breast implant expander products) and a rare, deadly cancer. In response to the serious dangers associated with breast implants, the Food and Drug Administration (FDA) has released new labeling recommendations in its recent draft guidance.
Data shows that people with breast implants face higher risks for developing certain types of cancers, such as a rare kind called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). So far, the FDA has received at least 9 reports of patient deaths and a total 457 cases of the cancer that are directly related to silicone and saline-based breast implants.
To warn people who have breast implants or are considering getting them about the possible deadly risks, the FDA is now recommending:
There are several goals behind the FDA’s new draft guidance, like explaining basic surgical and product information as well as providing information on saline and silicone gel-filled breast implants in particular. The FDA’s new guidelines also mandate providing data that supports a “reasonable assurance of safety and effectiveness.” To raise awareness on breast implant-associated lymphoma, the FDA wants to require manufacturers to provide warnings on the cancer and to encourage patients to report any adverse event linked to their breast implants.
In the past few months the FDA (along with many other health agencies around the world) have issued several widespread recalls of breast implants, including Allergan and Natrecelle BIOCELL-brand products. The agency wants people to know there are other serious risks associated with breast implants, too. Some of the most common ones include:
People with breast implants should familiarize themselves with the common risks and report any problems to healthcare professionals directly.
It is also important to known the signs and symptoms of the breast implant-associated cancer, BIA-ALCL. This cancer develops in or around breast implant scar tissue, or “scar capsule.” So far, there has not been one case of this cancer in someone who did not have texted implants or textured implant expanders – the only reported cases are in individuals who have them. Some symptoms commonly associated with the rare lymphoma are:
There are more symptoms associated with this cancer. To learn more about them, you can visit: https://biaalcl.com/about-bia-alcl/.
If you have textured saline or silicone-filled implants or textured breast implant expanders and are experiencing any of these symptoms, make an appointment with your doctor right away. This cancer is most deadly when it is not found and treated early – so if you are having symptoms, it is important to go get checked out.
If you have any additional questions about problems you experienced after getting saline or silicone-filled textured breast implants, someone at our firm can help. Please contact a representative directly.
If you were injured or became ill because of an unsafe or defective product, please contact the Philadelphia personal injury attorneys at Galfand Berger. With offices located in Philadelphia, Bethlehem, Lancaster, and Reading, we serve clients throughout Pennsylvania and New Jersey. To schedule a consultation, call us at 800-222-8792 or complete our online contact form.