Saturday, December 4

The new warning from the US Drug Administration on breast implants


Madrid

Updated:

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It is not enough to talk about it in the office. The FDA, the United States Drug Administration, wants plastic surgeons to inform their patients with clarity and detail of all the risks associated with breast augmentation surgery. And so that there are no doubts oblige physicians to notify all risks in writing that can arise, even years after surgery. The dangers and possible adverse effects will be listed in a standard document that all surgeons will offer to their patients.

The FDA has made the decision after gathering testimonies from women who felt they were cheated because their doctors did not warn them about all the complications that could arise.

In that document warnings will appear already

known and a new one: «LBreast implants do not last a lifetime. The agency does not put an expiration date on the prostheses, but remembers the need to periodically review the implants to monitor their good condition. The list will have to be signed by both the patient and their plastic surgeon.

Lymphoma risk

Those who are going to undergo this intervention will be informed that may require additional surgery to change implants, which can break and will also need to mention the possible relationship between breast implants and a very rare known type of cancer such as anaplastic large cell lymphoma. This oncological disease is not breast cancer, but a benign variant of lymphoma. It is usually cured with the removal of the affected implant and no other type of cancer treatment is usually necessary.

To date there are no conclusive data on why it may appear. No connection has been found between the disease and the content of the implants (saline or silicone). There are also no differences between those who receive an implant for cosmetic reasons or do it for reconstructive surgery after breast cancer.

Memory loss, pain, fatigue …

The list of possible problems that patients will have to sign also includes other very rare symptoms, but that some women with implants have experienced: memory loss, joint pain, fatigue …

The FDA ensures that its sole objective is to provide future implant users «Clear and understandable information on the benefits and risks of implants breast ». “By strengthening safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery,” Binita Ashar, FDA’s chief surgical device officer, writes in a community.

The FDA has also updated guidelines on what manufacturers will have to report, such as the amount of heavy metal chemicals in prosthetics. to do with post-approval studies.

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