FDA Wants Breast Implants to Have More Warnings
December 24, 2019
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with breast implants, the Food and Drug Administration (FDA) has released new labeling recommendations in its recent draft guidance.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.
The FDA’s New Recommendations
To warn people who have breast implants or are considering getting them about the possible deadly risks, the FDA is now recommending:
- Boxed warning,
- Patient decision checklist,
- Materials and device descriptions, which tell patients about the kinds and amounts of chemicals and heavy metals found in or released by breast implants,
- Rupture screening recommendations for silicone gel-filled breast implants, and:
- Patient device cards
There are several goals behind the FDA’s new draft guidance, like explaining basic surgical and product information as well as providing information on saline and silicone gel-filled breast implants in particular.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.
Other Risks Associated with 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:
- Systemic symptoms, which is commonly called Breast Implant Illness or BII,
- Additional required surgeries,
- Breast pain,
- Capsular contracture, or when scar tissue puts pressure on and squeezes the implant,
- Infection, and:
- Rupture of saline and silicone-filled implants. The rupture can be silent and unaccompanied by symptoms or sometimes present via deflation and other visible changes in breast size.
People with breast implants should familiarize themselves with the common risks and report any problems to healthcare professionals directly.
Symptoms of Breast Implant-Associated Lymphoma
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:
- Swollen lymph nodes,
- An increase in breast size,
- A change in breast or implant shape,
- Development of a lump or several lumps in or around the breast or armpit area,
- Itching or redness of the skin near the breast,
- Fluid around the implant seen on diagnostic imaging (e.g. an MRI), and:
- Lesions on the skin directly on or near the breast
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.
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