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FDA panels say women need better information about breast implants



SILVER SPRING, Md. – Members of a Food and Drug Administration advisory committee investigating the safety of breast implants, urged the agency on Tuesday to take steps to ensure that patients have a better understanding of the risks. This includes a rare cancer associated with a series of deaths around the world that emanate from the equipment.

Members commented on the conclusion of a two-day FDA hearing and supported a standardized, easy-to-understand consent form that presents the main risks Devices should be reviewed by patients and their physicians before a woman was operated on.

She said the FDA could negotiate the format and content of the consent form with patients, plastic surgeon groups, and manufacturers. Frank Lewis, chairman of the Board of the General and Plastic Surgery Equipment Agency, said the current documents written by manufacturers are too long ̵

1; some are more than 70 pages – and cumbersome. "They were designed to provide legal protection to companies," he said.

During the sometimes emotionally shattering hearing on implants, several women testified that they had not been sufficiently warned of implant risks and were damaged by the devices.

The FDA had asked the panel to hold the hearing and provide guidance on various complicated issues related to implants that have been causing controversy for decades.

The panel members made further suggestions for the FDA. One said that tissue removed when implants are removed should be analyzed by pathologists to find out what causes the disease or complication. Another said it was important to try to establish an official definition for "breast implant disease" – the constellation of autoimmune problems, many of which women claim is caused by implants – so the insurance company would pay to treat the conditions , The FDA said the weight of the evidence does not support such "systemic" effects of implants.

However, the panel did not seem to agree that implants should be removed from the market, including certain structured implants linked to cancer. Many patients and advocates demanded such a ban, but several panelists said they refused this time.

At the end of the meeting, however, Texas Plastic Surgeon Texas Chevray, a member of the panel, called for a ban on textured implants that are banned in other countries.

The FDA has identified 457 cases and nine deaths in the United States associated with cancer, referred to as breast implant-associated anaplastic large cell lymphoma. Worldwide, 600 cases and 17 deaths were reported. Several countries have banned some sort of structured device.

Diana Zuckerman, a longtime lawyer who is president of the National Center for Health Research, said the panel's recommendations were "rather vague," but she said the meeting was important because It allowed women to share their stories with the FDA and to tell the surgery panel. "We do not know what's next, but I'm confident," she said after the meeting.

The panel also said that the FDA should change its recommendation that women with implants receive MRI scans after three years to check for fractures. Starting after six years might be more practical, members said, taking into account the costs involved.

Facebook groups have attracted tens of thousands of women who said they were experiencing such discomfort following implant placement and then saw many of their symptoms subsided when the devices were removed. Nicole Daruda, who had her implants removed a few years ago, heads the largest group, Breast Implant Illness and Healing, with 70,000 members. "Hundreds of women come every day," she said.

The advisory committee, which includes plastic surgeons, epidemiologists and biomaterials experts, did not receive any formal votes during the two-day hearing. Instead, questions from the FDA were discussed.

About 400,000 women a year receive implants, 75 percent for cosmetic reasons, and the remainder for reconstruction after breast cancer surgery. Implants are filled with either silicone gel or saline; 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 that ban in 2005. The agency approved implants made by Allergan and Mentor in 2006 that led to long-term studies that have impacted women's health. Earlier this month, the FDA sent warning letters to Mentor and Sientra stating that they had not met these long-term study requirements.

Much of the two-day session highlighted the difficulty of making regulatory decisions when reliable data are not available Long-term data on the implications of implants. Members of the committee, for example, complained about the lack of control groups in studies that would allow researchers to compare patients who have implants with people they do not have.

Plastic surgeons and manufacturers defended the implants and said they have an important option for women who are undergoing breast cancer surgery or who want to have their breasts enlarged. Lisa Lynn Sowder, a plastic surgeon from Seattle who testified on Tuesday, said she has "never been a big fan of breast implants". However, she fears that some patient-driven social media sites make women unnecessarily anxious. She said some patients were "worried sick", which they read at the sites.

Patients and advocates had asked the committee to recommend that the FDA ban ban some products Doctors and patients should sign a two-page implant risk checklist prior to surgery.

Natalie Compagni Portis, a clinical psychologist who serves on the panel, said she only admitted that women had progressed. "Women felt dismissed," she said. "We can at least admit that something is happening."




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