Breast implants are a common procedure around the world. Tens of millions of women receive them for reconstructive or cosmetic reasons in the U.S. alone. With such a common procedure affecting so many women, any rare side effects could affect tens of thousands of people. Parker Waichman has already extensively covered the risk of developing […]
Breast implants are a common procedure around the world. Tens of millions of women receive them for reconstructive or cosmetic reasons in the U.S. alone. With such a common procedure affecting so many women, any rare side effects could affect tens of thousands of people. Parker Waichman has already extensively covered the risk of developing breast implant-associated anaplastic large cell lymphoma (BIAL-CL), but recently the U.S. Food and Drug Administration (FDA) has identified another potential source of grief for women; silicone breast implants
Silicone breast implants are one of the two categories of breast implants available to women receiving implants. The alternative to silicone breast implants would be saline implants. Silicone implants have not been reported to cause a wide variety of abnormal side effects. Usually, adverse symptoms such as the development of BIAL-CL are associated with textured versus non-textured breast implants.
Unfortunately, as the FDA announced on March 19, 2019, two breast implant companies, Mentor Worldwide LLC and Sientra Inc. were discovered to have failed to conduct consumer studies to analyze any potential long-term effects of silicone breast implants on the body over extended periods of time. While the FDA has always maintained that breast implants are not permanent, this means that there is a very real chance that many women who have claimed to have suffered because of various side effects linked to breast implants were brushed off because the research simply hadn’t been done.
With the knowledge of these companies’ failures and the increasing evidence that breast implants increase the risk of certain adverse effects, it becomes vital to understand what those side effects are.
According to the official FDA page on breast implants, the FDA’s list of official complications and adverse effects caused by breast implants are currently:
While this list is not very long, the risks associated range from disruptive to potentially fatal. In contrast, an independent breast cancer healing group cited by The New York Times has reported experiencing many more symptoms, with some including:
It must be noted that although there are many more symptoms on their site, this group is made of tens of thousands of women does not include medical professionals that are independently verifying these symptoms, but instead market themselves as a support group to share experiences. These reports are still somewhat valid, however, because the FDA is continuing to explore these reported symptoms as part of consumer-driven advocacy for increased research and regulation of silicone breast implants.
The FDA has now begun to seriously analyze the risks and benefits of breast implants, particularly silicone breast implants. In a press announcement from early March, the FDA confirmed a rising trend of breast implant recipients being diagnosed with BIAL-CL, and noted that the topic would be revisited in an upcoming meeting spanning March 25-26th.
Some subjects of discussion planned for that meeting include the side effects reported by the women’s health advocacy groups in users of silicone breast implants, as well as reports on the current number of diagnoses and fatalities that have stemmed from BIAL-CL. One thing that has been confirmed by the FDA is that, in women diagnosed with BIAL-CL, removal of the breast implants seems to lessen symptoms immediately. Providing rather damning evidence of a potential link between the two.
The FDA and other regulatory organizations worldwide are now struggling to bridge the gap in research that should have been done, and research that has been done. While this is a vital and important step for women who may one day face the choice of whether or not to receive implants, for the women who already have, their suffering has already occurred. For those women, Parker Waichman is here to help. Whether you personally have suffered these debilitating side effects or you have watched someone you love struggle with them, Parker Waichman LLP has the legal team that can pursue the makers of these unsafe products who failed to do the research to ensure long-term patient safety was guaranteed. Contact Parker Waichman today for a free consultation, and take the first step on the road to achieving justice.
