Millions of women worldwide have breast implants for cosmetic reasons and undergo this procedure for surgical reconstruction following mastectomies. Yet, the Food and Drug Administration (FDA) issued a stark new warning to two implant manufacturers as part of a larger federal review of the safety and long-term effects of medical devices. Women have alleged for years a variety of significant side effects from breast implants ranging from fatigue to memory issues to severe joint pain. Until now, their symptoms have been largely disregarded and the products continue to be available. The new FDA review addresses the concerning symptoms raised by patients and advocates.
Numerous medical devices, including breast implants, are widely used and range from hip replacement systems to contraceptives and pacemakers. The FDA regulates most medical devices under the Food, Drug, and Cosmetic Act, which grants them legal authority to review and approve new products in the U.S. The FDA previously reviewed silicone breast implants in the 1990s following numerous reports of illnesses by women using the devices and subsequently prohibited their use in many cases in 1992. However, a conditional approval in 2006 allowed this device back in circulation with the caveat that manufacturers systematically track patients for up to 10 years.
The FDA found that failure to follow these tracking requirements warranted official warnings to two manufacturers. In one case, the agency found that the company had not tracked the necessary number of patients in follow-ups as required in granting approval. Implant manufacturers and their consultants have disputed the findings. Although rare, the FDA has the authority to remove devices from the market if remedies are not taken.
Medical providers found that patients receiving breast implants had higher rates of certain uncommon diseases, including scleroderma, rheumatoid arthritis, and Sjogren syndrome, which attacks the auto-immune system. The authors of one study noted that they had not yet proven the direct connection to the implants, but for patient advocates, it further added to their claims. Patient advocacy groups that benefited from social media organizing have been rallying for review and regulation to address the concerning number of illnesses patients developed.
Other post-implant medical symptoms to be studied by the FDA are a variety of immune system illnesses that cause specific symptoms, such as joint pain, cognitive decline, and severe fatigue. A rare cancer of the lymphatic system has also been found in women receiving implants. Taken together, the FDA warnings and their new focus on additional research and review may give hope to those who have become ill after breast implants. Medical devices of all types are utilized with the goal of treating a condition or improving a disease, and patients who suffer detrimental consequences are entitled to a full review and medical care and compensation.
If you were harmed by a defective medical device, the Philadelphia defective medical device lawyers at Brookman, Rosenberg, Brown & Sandler can help. We will fight to obtain the compensation and justice you deserve. Located in Philadelphia, we represent clients throughout New Jersey and Pennsylvania, including Delaware County, Chester County, and Philadelphia County. Please call us at 215-569-4000 for a free consultation or complete our online form.