‘Don’t Ignore Us’: At Emotionally Charged Hearing Women Ask FDA To Better Regulate Breast Implants Linked To Cancer
The agency has been grappling with how to manage emerging science that shows that implants can trigger a rare form of lymphoma with the fact that for most people silicon is fairly safe. At the end of the day, the FDA panel didn't recommend any immediate restrictions on breast implants, but the issue is unlikely to disappear any time soon.
The New York Times:
Women At Breast Implant Hearing Call For Disclosure Of Safety Risks
Women with illnesses linked to breast implants challenged plastic surgeons, regulators and implant makers at an emotionally charged meeting on Monday at the Food and Drug Administration, demanding more information about the risks of the implants and calling for a ban on one that is associated with an unusual type of cancer. They asked implant makers to disclose the materials used in the devices and also called for a “black box” warning — a label that the F.D.A. can require, noting heightened problems with a drug or device. (Grady and Rabin, 3/25)
The Washington Post:
‘I Was Not Warned’ - Women Who Say They Were Sickened By Breast Implants Demand FDA Action
Telling searing stories about broken health, disrupted families and lost careers, the women pressed an FDA advisory panel to recommend more long-term research, bans or restrictions on certain products and a beefed-up informed consent process so that women have a clear understanding of the risks and benefits of the devices before they opt for surgery. “I was not warned" about the risks of implants, Jamee Cook, an advocate and former ER paramedic, told the FDA’s expert committee. Cook, who lives near Dallas, said that after getting implants in 1998, she suffered for years from swollen lymph nodes, chronic fatigue, migraines and a low-grade fever. She said she eventually had the devices removed, after which many, but not all, of her symptoms eased. (McGinley, 3/25)
The Wall Street Journal:
Patients Continue To Report Problems With Breast Implants
Jamee Cook, head of a women’s group called Breast Implant Victim Advocacy, said she was a paramedic and active when she got implants in 1998. Since then, she said, she experienced chronic fatigue, numbness and migraines—symptoms that were resolved when she had them taken out. “Women are still complaining of the exact same issues” they complained of in 1992 when silicone implants left the U.S. market, she said. “The FDA has not fulfilled its responsibility to protect patients.” Nearly three decades after the FDA first pulled silicone breast implants off the U.S. market and then allowed some back on, women continue to report debilitating conditions to the agency. The FDA is revisiting the issue again this year and is grappling with efforts to study which issues are proven and which not proven. (Burton, 3/25)
The Philadelphia Inquirer:
'I Was Deceived’: Women With Breast Implant Illnesses Tell FDA Panel Of Cancers, Chronic Pain, Disability
Plastic surgeons are supposed to make certain that women getting breast implants understand the risk of fairly common problems, including rupture, breast hardening, and additional surgery.But doctors don’t have to disclose what Jamee Cook showed Monday during her presentation to a U.S. Food and Drug Administration panel. The advisers are reexamining the safety of breast implants in light of new concerns and evidence that the prosthetics can make some women chronically ill with numerous autoimmune conditions and even a rare cancer. (McCullough, 3/25)
The Associated Press:
US Experts: Too Soon To Pull Breast Implants Tied To Cancer
Government medical advisers said Monday it's too soon to ban a type of breast implant that has recently been linked to a rare form of cancer, saying more information is needed to understand the problem. The Food and Drug Administration panel didn't recommend any immediate restrictions on breast implants after a day reviewing the latest research on the risks of the devices, which have been subject to safety concerns for decades. (3/25)
