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The FDA allows the sale of breast implants related to cancer, strengthens warnings



Women who consider breast implants will soon receive stronger formulated warnings about the dangers of the products before deciding to get the surgery, and the agency will continue to study the problem.

BIA-ALCL is predominantly associated with a structured type of implant, rather than the smooth version. The disease is slowly growing and is treated when detected early.

At least 457 women in the United States have been diagnosed with cancer, according to the FDA, and nine have died as a result. The cancer affects the cells of the immune system and can be found around the breast implant.

Facts that international health trusts have moved to ban the sale of textured implants, the FDA says the market share in these countries can reach 80% while the US market share is small in comparison.

  The FDA reports several cases of cancer related to breast implants

"The type of macro-textured implants targeted by some of our international counterparts represent less than 5% of the breast implants sold here, the agency said in a statement. "At this point, the FDA does not believe that, on the basis of all available data and information, the entity meets the prohibition standard set forth in the Federal Food, Drug and Cosmetic Act." Lack of action is disappointing, said Jamee Cook, co-founder of the breast implant victim, who attended the FDA's public meeting.

"Not to ban the structured implants is very discouraging for us and the patients who have lymphoma," Cook said. "We will continue to push for that ban, although it is not a move they are willing to do yet. "

About 10 million to 11 million women in the world have breast implants ater, according to the American Society of Plastic Surgeons and the Plastic Surgeon Fund.

The FDA increased the possibility of the disease in 2011, saying that there was a small but significant risk of cancer after receiving breast implants. The doctors asked if they had noticed changes in the patients and encouraged women to check for symptoms such as fluid buildup or mass around the implants. The symptoms of the cancer also include swelling and redness around the breast implants.

Since that report, the scientific community has learned more about the relationship between breast implants and large-cell anaplastic lymphoma.

Improving Warnings

Besides the BIA-ALCL, the agency said it was concerned about the risk of implant fractures and a condition called capsule contracture, where the breasts become hard and unknown, causing chronic pain and an increase in immune disorders. [19659003] "We have heard from the patients that their implants may be associated with health conditions involving the immune system's response to these devices, resulting in a number of symptoms such as chronic fatigue, cognitive problems, joints and muscle pain," the FDA said. 19659006] Chronic fatigue syndrome may be due to an overactive immune system, study findings "data-src-mini =" // cdn.cnn.com/cnnnext/dam/assets/181217100612-02-chronic-fatigue-small-169.jpg "data-src -xsmall = "// cdn.cnn.com/cnnnext/dam/assets/181217100612-02-chronic-fatigue-medium-plus-169.jpg" data-src-small = "http://cdn.cnn.com /cnnnext/dam/assets/181217100612-02-chronic-fatigue-large-169.jpg "data-src-medium =" // cdn.cnn.com/cnnnext/dam/assets/181217100612-02-chronic-fatigue- exlarge-169.jpg "data-src-large =" // cdn.cnn.com/cnnnext/dam/assets/181217100612-02-chronic-fatigue-super-169.jpg "data-src-full16x9 =" // cdn.cnn.com/cnnnext/dam/assets/181217100612-02-chronic-fatigue-full-169.jpg "data-src-mini1x1 =" // cdn.cnn.com/cnnnext/dam/assets/181217100612-02 -chronic-fatigue-small-11.jpg "data-demand-load =" not-loaded "data-eq-pts =" mini: 0, xsmall: 221, small: 308, medium: 461, large: 781 "src = "data: image / gif; base64, R0lGODlhEAAJAJEAAAAAAP /////// wAAACH5BAEAAAIALAAAAAAQAAkAAAIKlI + py + 0Po5yUFQA7" />

While acknowledging that there was no "final proof that breast implants caused these symptoms," the agency said that the fact that many Immune systems disappear when the implants are removed, meaning that "women consider a breast implant to be aware of these risks. "

Labeling changes such as box warnings and patient decision checklist may be some of the ways in which the agency communicates with some of the significant health problems associated with breast implants.

They were important changes that Breast Implant Victim Advocacy wanted, Cook said .

"The FDA said they only considered these actions," she said, "but based on our conversations over the last few weeks, I have really high hopes that they will pursue them.

Breach of adverse reaction reporting

Producers of breast implants will also face a significant change in how side effects are reported, the FDA announced, previously manufacturers could provide a summary of the patient's problems or concerns, but that method did not up "unusual, unique or unusual unwanted events, which, in the case of breast implants, included BIA-ALCL," the FDA said.

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In the future, manufacturers will be required to file individual reports of side effects that will be made publicly available in the coming weeks, the agency said.

Unit Events Founder Madris Tomes , which developed a tool to search for unwanted events in the FDA's database, said the action "was a step in the right direction gene. "

" It appeared that the summaries contained a lot of data that should have been made available before the meeting, "she said, adding that unwanted data should never be withheld from the public.

The FDA also said it was planning to increase partnership with patient registry groups such as PROFILE, which collects data on patients with BIA-ALCL diagnosis, and the National Breast Implant Register, which was created last year.

Although applauding the registry's work in its statement, the FDA said "more needs to be done to increase number of healthcare professionals contributing to the registry and types of information collected by the registry. "

The Agency pointed out that the risk of breast implants has been monitored since 2011 and considers the problem a priority.

CNN's Jacqueline Howard and Kevin Flower contributed to this report .


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