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SILVER SPRING, Md. – Members of an advisory committee to review breast implant safety urged the agency to take steps to better understand patients' risks, including rare cancers associated with cancer. several deaths around the world – posed by the devices.
The members, responding to a two-day hearing before the FDA, indicated their support for an easy-to-understand, standardized consent form that would outline the key risks of the devices and would be reviewed by patients and their doctors before the intervention of a woman.
They added that the FDA could negotiate the format and content of the consent form with patients, groups of plastic surgeons and manufacturers. Frank Lewis, chairman of the agency's agency committee on general and plastic surgery, said the documents currently written by the manufacturers are too long – some are over 70 pages long – and complicated. "They were built to provide legal protection for businesses," he said.
During the hearing of the implants, sometimes emotionally heartbreaking, several women testified that they had not been adequately warned of the risks associated with the implants and that they had been damaged by the devices.
The FDA had asked the committee to hold hearings and provide guidance on several complex implant issues that have fueled controversy for decades.
Panel members offered additional suggestions to the FDA. One of them said that pathologists should analyze the tissue removed during the removal of the implants to try to understand what causes the disease or the complication. Another said that it was important to try to establish an official definition of "breast implant disease" – the constellation of autoimmune problems that, according to many women, are caused by implants – so that insurance pays the treatment of ailments. The FDA has stated that the weight of evidence does not support such "systemic" effects of implants.
However, the panel did not seem to agree on the recommendation to remove any implant from the market, including some textured implants related to cancer. Many patients and advocates have called for such a ban, but several panelists have said they oppose this measure at this stage.
At the end of the meeting, however, Texan plastic surgeon Pierre Chevray, panel member, called for the ban on textured implants banned in other countries.
The FDA has identified 457 cases and nine deaths in the United States associated with cancer, called anaplastic large cell lymphoma associated with a breast implant. Six hundred cases and 17 deaths have been reported worldwide. Several countries have banned a type of textured device.
Diana Zuckerman, a long-time lawyer and president of the National Center for Health Research, said the panel's recommendations "were rather vague," but said the meeting was important because it allowed women to tell their story the FDA and at the operation. sign. "We do not know what will follow, but I have hope," she said after the meeting.
The panel also said the FDA should change its recommendation that women with implants should start getting an MRI scan three years later to detect any ruptures. Starting after six years may be more convenient, members said, considering the costs.
Facebook groups have attracted tens of thousands of women who claim to suffer from such affections after implant placement and then found that many of their symptoms lessened once the devices were removed. Nicole Daruda, who had her implants removed several years ago, leads the largest group, Breast Implant Illness and Healing, which has 70,000 members. "Hundreds of women are joining each other every day," she said.
The advisory committee, which includes plastic surgeons, epidemiologists and biomaterials experts, did not proceed to a formal vote during the two-day hearing. Instead, he discussed issues raised by the FDA.
Each year, about 400,000 women get implants, 75% for aesthetic reasons and the rest for reconstruction after breast cancer surgery. The implants are filled with silicone gel or saline solution; their surfaces are smooth or textured. The majority of implants used in the United States are smooth.
The FDA banned most implants in 1992, but lifted it in 2005. The agency approved Allergan and Mentor implants in 2006, requiring them to conduct long-term health impact studies. women. Earlier this month, the FDA sent warning letters to Mentor and Sientra, telling them that they had not complied with these education requirements at long term.
Most of the two-day session highlighted the difficulty of making regulatory decisions in the absence of reliable, long-term data on the effects of implants. Committee members complained, for example, about the lack of control groups in studies that allow researchers to compare patients with implants with those who do not.
Plastic surgeons and manufacturers defended the implants, claiming that they offered an important option to women who are undergoing surgery for breast cancer or who wish to have an enlarged breast. Lisa Lynn Sowder, a Seattle plastic surgeon who testified on Tuesday, said she "had never been a big fan of breast implants," but she fears that some patient-focused social media sites only make women anxious. She said that some patients "are worried" by what they read on the sites.
Patients and advocates had asked the committee to recommend to the FDA to ban certain products, to require a "black box" warning on all devices and to ask doctors and patients to sign a list of Two-page control on the risks of implants before surgery.
Natalie Compagni Portis, a clinical panelist psychologist, said that simply acknowledging that women had suffered was a step forward. "The women felt sent away," she said. "We can at least recognize that something is happening."
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