December 1, 2021

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FDA physicians are required to report potential risks of breast implants

Some effects of breast implant surgery include fatigue, skin rash, memory loss and confusion (Getty Images)

After breast transplant surgery, there are many women who have had problems for years. One of the consequences Fatigue, skin rash, memory loss and confusion Among other collectively known health problems “Breast Transplant “. Some implants have even been linked to rare and life-threatening cancers. For many years, activists have sought an informed consent process so that patients have a clear understanding of the risks and benefits before choosing surgery.

The Food and Drug Administration (FDA)’s new regulation restricts the sale and distribution of breast implants to providers and facilities that provide patients with a checklist of risks. Published as Creature. Checklist “To help ensure that the patient understands the risks, benefits, and other information about the breast implant device, it should be reviewed by the healthcare provider with the prospective patient. The company said in a statement. Moreover, he said The patient should have the opportunity to sign the patient’s checklist, which must be signed by the doctor fitting the device.

Even the regulators Demanded new warning labels with different types of breast transplants. Those labels should be with the patient’s results checklist And for women receiving silicone gel-filled implants, be advised to undergo routine tests for possible rupture leaks. Companies have 30 days to post updated tags on their websites.

“By strengthening the safety requirements for manufacturers, the FDA is working to close the information gaps for anyone considering breast implant surgery,” said Binita Azhar, director of the Office of Surgical Equipment and Control. Health.

Last year regulators recommended the use of a cautious, very strict DFA precaution in the black box on the product label to clearly list potential problems associated with the devices.  The guide also suggested that physicians use a patient-determined checklist to guide consumers through potential risks (Getty Images)
Last year regulators recommended the use of a cautious, very strict DFA precaution in the black box on the product label to clearly list potential problems associated with the devices. The guide also suggested that physicians use a patient-determined checklist to guide consumers through potential risks (Getty Images)

Last year, Regulators recommend Manufacturers should use strict DFA precautions, which clearly list the warning box on the product label and the potential problems associated with the device. That too is the guide Physicians are recommended to use a list From Verification of patient results Guiding consumers through potential risks.

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Announcement this Wednesday Those recommendations made it a necessity for the sale and distribution of breast implants.

The patient checklist lists common risks associated with breast transplant surgery, such as pain, scarring, asymmetry, and infection. It also warns of rare risks, including cancer of the immune system known as anaplastic large cell lymphoma associated with breast implants. Rare cancer and highly documented cases More than a third of deaths Associated with difficult breast transplants made by Allergan Since then They have Retired From the market.

And that list warns “Breast transplant surgery is not a device for life” It may eventually require removal or replacement. According to the FDA , They were removed for one in 5 women who underwent implants Eight to ten years. Both silicone gel and salt-filled implants can leak or break. Since it is very difficult to detect leaks in silicone gel filled implants, women who receive such a device should get regular pictures to check for leaks.

The list warns that “breast implants are not a lifetime device” and may eventually require removal or replacement (Getty Images)

In 2019, many women revealed serious health problems through their breast transplant surgery. The They told the FDA The truth is that doctors do not discuss risks It made them vulnerable. They described leaving the business because of those problems and wasting time with family.

Lymphoma associated with breast transplants is rare. Doctors in The United States earns about 400,000 Implant surgeries each year and, in early 2020, FDA documented Worldwide, 573 people have been diagnosed with cancer and 33 have died.

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Three-quarters of patients receive implants Make decisions for aesthetic reasons; The rest get them as part of the restructuring Breast cancer surgery.

Lymphoma associated with breast transplants is rare.  Physicians in the United States perform approximately 400,000 implant surgeries each year, and by early 2020, the FDA had recorded 573 cancers worldwide and 33 patients had died (Getty Images)
Lymphoma associated with breast transplants is rare. Physicians in the United States perform approximately 400,000 implant surgeries each year, and by early 2020, the FDA had recorded 573 cancers worldwide and 33 patients had died (Getty Images)

In 2010 A scandal Related to the breast prostheses that occupy a portion of the agenda. The French company PIP used unapproved silicone gel for medical use, instead of approved nozzle gel.

It is estimated that between 2001 and 2010, half a million fraudulent PIP prostheses were manufactured and sold worldwide., Use of ineffective controls by the certification body TÜV Rheinland.