Women claiming they have been injured by breast implants have called for new consumer protection measures from the Food and Drug Administration, including more information on potential risks and a ban on devices used with the The most serious complications, including cancer, are related
The women related brutal stories of broken health, destroyed families and lost careers, and urged an FDA advisory panel to seek more long-term research, bans or restrictions on certain products, and a strengthened consent procedure Women should have a clear understanding of the risks and benefits of the devices before they decide to have surgery.
"I have not been warned about the risks of implants," said Jamee Cook, a lawyer and former emergency room paramedic, to the FDA's expert committee. Cook, a woman living near Dallas, said she had been suffering from swollen lymph nodes, chronic fatigue, migraine, and mild fever for years after inserting implants in 1998. The devices were removed and many but not all of her symptoms subsided.
The FDA recently said it has looked more closely at implants that have been causing anger and competition for decades. The Agency asked the Advisory Committee on General and Plastic Surgery Equipment for recommendations on a range of topics, and Cook's statement was part of a two-day hearing that will be held on Tuesday on key issues.
Several plastic surgeons argue on the podium Be careful and say that implants are generally safe and an important option for women who desire breast augmentation or reconstruction after breast cancer surgery. They said that women's choices should not be restricted. About 400,000 women receive implants every year, 75 percent for cosmetic reasons, and the remainder for reconstruction after breast cancer surgery.
Many of the dozens of patients attending the meeting at the FDA headquarters in Silver Spring, MD, wore ribbons They graphically express their concerns about two types of diseases that they say are implants. Black and white ribbons symbolized what is today referred to as "breast implant disease," a constellation of autoimmune problems that includes joint and muscle pain, allergies, and fatigue. Pink and green bands signify unusual lymphoma that links health agencies around the world, including the FDA, to a few implants.
Anastasia Allmendinger, a 53-year-old resident of Newport News, Virginia, said she had implants in 2010, and years later, cancer was diagnosed, called anaplastic large cell lymphoma or ALCL. She has undergone surgery to remove the implants, remove chemotherapy and stem cell transplantation, and she is fine now, but manufacturers should be held accountable for the diseases and women should be better informed. Experts say many patients can only be successfully treated by surgery.
Many of the supporters who spoke on Monday called for a ban on textured implants – the species most associated with cancer. There is evidence that the problem could be caused by bacterial infections with implants.
The FDA has detected 457 cases of lymphoma and nine deaths in the United States. More than 600 cases and 17 deaths have been reported worldwide.
The other major disease associated with autoimmune and connective tissue disease has long been in conflict with the FDA and the patient community.
Thousands of women have complained about autoimmune and connective tissue problems in social media, but the FDA has repeatedly pointed out that the "weight of evidence" shows no signs of "systemic" disease from implants.
This opinion was made last September when Dr. The MD Anderson Cancer Center found that silicone implants were associated with higher rates of autoimmune diseases such as scleroderma and rheumatoid arthritis than the general population. A leading author, Mark Clemens, said the study did not show cause or effect, but signaled a cause for concern.
The FDA immediately expressed skepticism and said the study was flawed. Binita Ashar, Director of the FDA's Surgical Equipment Agency at the FDA's Center for Equipment and Radiological Health, also said the agency is stepping up long-term monitoring of implants and using patient registries to track device complications.
This view was repeated in the agency's announcement about the meeting that began on Monday. The FDA said that "there is insufficient evidence to show a link between breast implants and diagnoses in rheumatoid or connective tissue disease." But it added, "There are numerous breast implant patients who come together on social media to discuss a variety of symptoms – symptoms that may or may not meet the diagnostic criteria to be classified as disease."
Diana Zuckerman, president of the National Center for Health Research, said in an interview that she does not understand "why the FDA seems so open-minded" about the scientific evidence that at least some women have developed autoimmune diseases as a result of their breast implants. "We always said that we do not know what the percentage is. It's only for the women who are sick that it makes them better, "she said.
Zuckerman presented data from a study conducted by her group on Monday that involved more than 400 women whose implants were removed for health problems. In most cases, women's health improved and the study has not yet been published.
The FDA banned most implants in 1992, but lifted the ban in 2005. The agency approved Allergan and Mentor's manufacturing in 2006 Implants and invited them to conduct long-term studies on the impact on women's health.
Recently, the FDA stepped up its testing of devices, sending warning letters to two major implant manufacturers last week, saying they had not performed any long-term safety studies on the devices and warned them that the devices could be ordered from the market if the Studies are not completed. The agency also recently said it would take a closer look at how materials used in a range of surgical implants – including those used for hip and knee replacement – could potentially affect health.
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