The safety of breast implants is under scrutiny this week as the Food and Drug Administration opened up a public hearing on the issue. Hundreds of thousands of women have encountered mysterious health problems that they believe are connected to implants.
Paula Wilson is one woman who wants to point out the downside of implants. In this video, she discusses the abnormal things that went on with her body for years. Once the breast implants were removed, her problems ceased.
Other women who have received them report having fatigue, neurological problems, headaches, immune system issues, and muscle pain which they attribute to gel implants. Of particular concern is a type of cancer called anaplastic large cell lymphoma which only impacts those with implants.
Cancerous cells grow in the scar tissue around the breast implant site. NBC reports that all cases of this cancer are connected to textured implants, though smooth implants are what’s typically used for surgeries in the U.S.
Still, 12% of women in America have textured versions and over 400 women in the U.S. have been diagnosed with this cancer. 17 deaths have been documented globally. At the hearing this week, women are urging the FDA to ban textured breast implants to prevent their cancer-causing effects.
Last week, the FDA sent letters to two manufacturers for failure to complete studies that examine the long-term health effects of gel-filled breast implants. According to the FDA’s announcement, Mentor Worldwide LLC and Sientra, Inc. were both issued warnings.
“We’re issuing these warning letters based on the manufacturers’ low recruitment, poor data, and low follow-up rates in their required post-approval studies. We expect these manufacturers to meet the pre-specified study requirements in order to ensure the collection of long-term data that can be used to inform long-term patient safety. Post-approval studies, along with other surveillance tools such as adverse event reports, registries, and scientific literature, allow the FDA to help ensure the safety of medical devices and protect patients.”
These measures are part of a larger investigation into the effects of breast implants. During the hearings, – which are taking place for two days – the FDA’s committee that oversees plastic surgery and medical devices will hear from patients, health care providers, and industry professionals about the benefits and troubles associated with implants.
As it stands, the agency has no documented clinical evidence that support a link between breast implants and health impairments. That is the reason officials called for the meeting, so they can get a better idea of how to monitor the industry and mitigate health problems.
Although the committee is hearing about the many women who have benefited from implants and who have had no negative health reactions, others who are sharing their stories want the public to know that symptoms did not show up for them for many years.
Officials want health care providers and manufacturers to implement follow-up programs for recipients that better monitor their health. Patients want “black box warnings” to be issued on implants that clearly indicate the risks associated with them, including the possibility of cancer.
Learn more about Paula Wilson’s story and the health conditions linked to implants by clicking on this video.
Does someone you know have breast implants and unusual health problems? Were you aware that there’s little monitoring post-surgery? What do you think of the FDA’s hearing?