Friday , August 19 2022

They analyze the safety of breast implants – 03/26/2019


Breast supplement is the most common cosmetic surgery in Argentina and several countries. After the scandal opened almost a decade ago by the French PIP prostheses – filled with silicone gel that was not suitable for medical use and affected more than 20 thousand women -, experts and regulatory authorities focused attention on the complications that may arise after the intervention The last alarm some years ago had sparked the spread of about 400 cases worldwide of women who developed a rare form of cancer in the proximity of the prosthesis. Between yesterday and today, experts organized by the Ministry of Food and Drugs (FDA) conducted an extensive review on the safety of implants.

The FDA is looking at how to get to grips with the new scientific knowledge that implants can cause a rare form of lymphoma that grows in the scar tissue around the breasts. The agency identified 457 cases worldwide, including 9 deaths. Almost all include a type of textured implant that is designed to not slip and reduce the tissue dimension of the scar. However, during yesterday's presentations, the majority of the 19 members of the panel – including plastic surgeons and oncologists – said – t the evidence was not sufficient to order that these implants be removed from the market, according to the AP news agency. It is expected that the US regulatory agency will publish an official document in the coming days with the outcome of the review.

This has been the agency's position for some time the implants are safeHowever, while it is recommended that the prosthesis should be given to patients before the intervention and that they are told about the benefits and risks of the different types.

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Great Cell Lymphoma (LACG) associated with breast implants is not breast cancer or breast tissue, but a type of lymphoma that is not Hodgkin's lymphoma, a tumor in the lymphatic system in very rare circumstances it can develop near the prosthesis. In last month's document, the FDA notes that the number of cases identified is small in relation to the 1.5 million patients implanted every year worldwide, but explains that "the confirmed data and the public information so far suggest that breast patients have a greater risk of developing it."

Our entity is rare, its actual frequency is still unknown and there are no conclusions about the type of implant or type of surgery that might predict the condition, though, in most cases t , which occurred in women with textured surface implants, there were also reports where it was associated with smooth surfaces.

"The number of cases is very low", confirms in dialogue with Clarin Horacio Mayer, deputy chief surgery Hospital of Italy. "The message must be encouraging. It doesn't have to produce paranoia among the implanted patients that they have to remove the implant, or not to act (those who want to do it. ). We have a very rare entity, which affects very few women and it is known that there are multiple factors in those affected, not just the implant. It is a multi-factor disorder, where there are genetic, environmental issues. It is possible that some types of textures, macrotextures are included, as well as bacteria, "he added. T

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The specialist, a member of the Aesthetic Plastic and Reconstructive Argentine Surgery (SACPER), stressed that it is not a type of cancer that occurs entirely in breast implants. "It has also been associated with dental implants, hips. We respond to implants," he stressed and insisted that it was something very rare. "It's developing in the capsule that surrounds the implant. It's just a healing of the capsule in most cases."

Argentina Protocol

Last year, in our country, the Mastology Society (USA) developed Argentina and the Argentine Plastic, Aesthetic and Reconstruction Society (SACPER) joint protocol clear doubts and response to concerns about the subject.

In terms of warning symptoms, the document states that the most relevant early sign is the t inflammation of the breast with no trauma originating. This is due to the production of serous fluid around the implant and it is called late seroma as it usually appears a year after surgery. It rarely starts as a nodule, tumor or extended lymph nodes. Before any of these symptoms advise you to consult the mastologist (mammary health specialist), who will ask for the relevant studies.

"Although each doctor will decide which study should be carried out, in these cases ultrasound is initially recommended as this is the simplest method of identifying seromas. Then an MRI can be requested and finally a hole; It is evaluated with an analysis of the name immunohistochemistry for positive CD-30 lymphocytes and negative T-ALK lymphocytes, when presenting joint work Eduardo González, US president.

The protocol agreed by the two scientific associations emphasizes the importance of regular mammal controls and seeks to reassure all those women who have or are planning breast surgery for implants: " provided they are performed by certified medical professionals, places enabled for this purpose are guaranteed the hygiene and safety required for this type of surgical procedures, t and with quality products approved by ANMAT and FDA, t women should not worry, but look after their mammary health, visiting the mastólogo from time to time ", he concluded the president of the ITT.

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