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2024
Absorbable breast repair implant released after breast cancer treatment
On August 29, 2024, the American company Melodi Health announced the release of the absorbable Matrix implant for patients diagnosed with malignant breast lesions. The product is intended for women undergoing breast reconstruction after mastectomy. Read more here
Price increase for breast augmentation in Moscow doubled
During the year, prices for breast augmentation services in Moscow almost doubled. This is due to fluctuations in exchange rates and difficulties with logistics, which are observed in connection with the formed geopolitical situation. This was announced in mid-March 2024 by representatives of leading plastic surgery clinics in the Russian capital.
As noted by the Telegram channel Shot, the most popular implants, products of the American company Mentor, have risen in price most significantly. They are used both for breast augmentation and for reconstruction in connection with various diseases, in particular malignant formations. Each silicone implant is filled with a special cohesive gel, which has a uniform texture and helps to maintain a sense of naturalness.
It is said that as of the beginning of 2024, the operation to install Mentor implants in Moscow costs an average of 400 thousand rubles, while a year earlier the cost was about 200 thousand rubles. The price varies depending on the anatomical features of the patients and the skill of the surgeon. French Sebbin implants have also risen in price: the cost of the procedure is on average 300 thousand rubles.
Many metropolitan clinics, in order to reduce the cost of breast augmentation operations, use domestically produced consumables and operate on equipment from China, which is said to have performed well enough.
Breast plastics are said to be on the list of the most common aesthetic surgeries in the world. Experts say that the same implants can last several decades, and there may be cases when they have to be changed a short time after surgery. This period depends on a number of factors, including the correctness of the installation, the quality of the material, the individual characteristics of the patient's body, etc.[1]
2023: U.S. officially counts 24 breast cancer cases due to breast implants
On March 8, 2023, the US Food and Drug Administration (FDA) released an update on cases of squamous cell carcinoma (SCC) associated with breast implants.
It is noted that in the United States alone, more than 300 thousand surgical operations are performed annually to install implants in order to increase the size of the chest or reconstruct the shape after injuries and certain diseases. At the same time, various complications are recorded in some patients, including anaplastic large-cell lymphoma and SCC (a potentially aggressive tumor that develops in the scar tissue around the implant).
One of the first reports of squamous cell carcinoma associated with breast implants appeared in 1992. Then plastic surgeons from St. Louis University School of Medicine reported that the malignant formation manifested itself 15 years after the woman had a breast augmentation procedure.
The FDA says 24 cases of SCC related to breast implants have been reported as of Jan. 15, 2023. The age of patients at diagnosis ranged from 40 to 81 years. In most cases, symptoms included swelling and/or chest pain, as well as the appearance of tubercles and discoloration of the skin. There is information about deaths associated with the progression of this cancer. However, the causes of SCC and risk factors remain unknown.
Health care providers and people who already have or plan to have breast implants should be informed about cases of squamous cell carcinoma and the various lymphomas in the capsule around the breast implant. We continue to work with regulators, scientific experts and breast implant manufacturers to gather all available information about such malignancies, the FDA said in a publication.[2]
2022
Ministry of Industry and Trade of the Russian Federation: The share of domestic breast silicone implants should grow from 0% to 100% by 2024
The Ministry of Industry and Trade in mid-November 2022 updated the import substitution plan in the chemical industry, approved in 2021. According to the plan, the share of domestic breast silicone implants should grow from 0% to 100% by 2024. As of the end of November 2022, only foreign manufacturers registered silicone breast implants in Russia:
- French Sebbin Groupe,
- German Polytech Health & Aesthetics,
- Netherlands Mentor Medical Systems,
- Korean HansBiomed,
- Brazilian Silimed - Industria de Implantes.
US authorities warned of cancer and lymphoma due to breast implants
In September 2022, the Food and Drug Administration (FDA) issued a warning informing patients and doctors of cases of squamous cell carcinoma (PCC) and lymphomas located in the sheath or scar tissue around breast implants.
 | Following initial comprehensive analysis, we currently believe that the risk of PCC and other lymphomas occurring in the tissues around breast implants is rare. However, in this case, as well as when identifying the safety risks of medical devices, we wanted to provide the public with clear and understandable information as soon as possible, the warning says. |  |
There are few documented cases. Fewer than 20 cases of carcinoma and fewer than 30 cases of enveloped lymphoma around the breast implant have been claimed to be known. It is not known whether breast implants cause these species cancer or whether some implants pose a greater risk than others.
However, given the history of the implants and their widespread distribution, federal health officials believe the concern is justified. In some cases, the diagnosis was made to patients years after the installation of breast implants and was accompanied by manifestations such as swelling, pain, tumors or skin damage.
New cases of lymphoma in scar tissue differ from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), reported as a potential risk more than a decade ago.
| | These diseases are extremely rare, and the new warning should not be universally alarming, says Mark Clemens, a plastic surgeon and professor at MD Anderson Cancer Center University of Texas in Houston. Realizing that the disease is related to breast implants has already allowed us to be more aware that other things may be happening in this area, "he said. | |
| | It has long been known that scar tissue, such as that formed after breast implant surgery, can lead to squamous cell carcinoma. A wound that tries to heal for a long time can develop into such things. But the exact nature of the link between the implant and cancer, and whether the implant causes cancer, is not yet clear, Clemens added. | |
Authorities note that they will soon complete a thorough analysis of the scientific materials and continue to work with the American Society of Plastic Surgeons to identify ways to collect more detailed information about cancer cases in the tissues around the breast implant.[3]
2021: Popular blogger dies of complications after plastic surgery
In November 2021, in Krasnoyarsk, after plastic surgery in one of the clinics, the popular blogger and personal fitness trainer Yana Fialkovskaya died. The woman performed surgery to correct the shape of the chest. Read more here.
2020
Worldwide, 2,500 breast implant side effects recorded in a year
In mid-August 2020, it became known that about 2,500 side effects associated with breast implants were registered in the world over the year. Among other things, an increase in breast cancer cases has been reported.
The term "breast implant disease" is rare in the medical literature, but is often used by patients and healthcare professionals when reporting side effects associated with breast implants. In total, between January 2008 and October 2018, 1,080 similar cases were reported, and from November 2018 to October 2019, this number increased by another 2,497 cases.
The ten most common side effects include fatigue (49%), confusion (25%), joint pain (25%), anxiety (24%), hair loss (21%), depression (19%), rash (18%), autoimmune diseases (18%), inflammation (18%) and/or weight problems (18%). Researchers are studying these symptoms to better understand their origin and association with breast implants.
Regulatory authorities also note a sharp increase in cases of cancer associated with breast implants: from July 2019 to January 2020, 733 cases were registered. The increase compared to the same period was 160 cases, the number of deaths associated with these cases increased from 3 to 36.
Cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a subtype of non-Hodgkin lymphoma, began to be reported in 2011. The majority of BIA-ALCL cases (620 cases) were related to implants manufactured, in Allergan 47 cases the implant of an unknown manufacturer was the cause of the disease. A total of 36 deaths were reported, but the manufacturer was known in only 16 of them, and in 15 of 16 cases the Allergan breast implant was the cause.[4]
Imprisonment of a false surgeon for implanting vasilin instead of breast implants
On July 9, 2020, the Leninsky District Court of the city of Grozny convicted the false surgeon Rosa Dushaeva, who pumped Vaseline oil on her breasts. Read more here.
What the consequences of bursting breast implants can be
On April 27, 2020, it became known about 23-year-old Brogan Rea, a resident of the English village of Borham, who almost died as a result of careless and unprofessional breast reduction surgery.
According to Rea, her breasts began to grow when she was 10 years old and by the age of 23 had grown to the size of a 36H (breast girth 108-110 centimeters). When she gave birth, she feared that large breasts might inadvertently strangle her baby. The chest caused other inconveniences: due to the large weight, the back quickly tired and constantly hurt, and wounds formed on the shoulders due to the strong pressure of the bra straps.
Having decided to reduce her breasts, Ri registered with the National Health Service of England, but soon found out that another 450 thousand women were in line before her. Upon learning of this and the condition of his daughter, his father offered to pay for the operation in a private clinic. After that, the girl for 2 years was looking for a suitable place for the operation, reading reviews on the Internet. Finally, her choice fell on a clinic in Turkey.
The operation cost 3 thousand pounds sterling (approximately 273 thousand rubles) and included 4 nights of accommodation in a 4-star hotel and one night in a hospital ward. After the operation was completed, she was sent to a hotel, where she was left without medical attention, Rea said. She had a fever, could not get out of bed for a long time and lay on a sheet pumped in blood and urine.
In the end, she found strength in herself, gathered and drove to the airport to return home. There were no direct flights, and she took a ticket with a transfer in Ukraine. The total travel time was 7 hours.
| | The return journey was very long, I was exhausted by the time I flew to Gatwick. I shouldn't have lifted anything, but when I left the plane I had to take my bag. I felt my breasts bursting, exposing open wounds, 'she shared. | |
When the girl came home and took off her clothes, a terrible picture opened up to her gaze: the breasts were unequal, one of them had a square shape and was just above the other. A greenish pus flowed from the wounds, and the nipples blackened and looked dying. "With all this, the breast size was reduced to only 36F (104-106 centimeters)," she shared, adding that her desire was to reduce to at least 36D (98-100 centimeters).
The clinic, in response to Ri's complaint, stated that it could correct the shortcomings, but for an additional fee of 579 pounds (approximately 53 thousand rubles), excluding travel and accommodation costs. The girl refused, saying that she would "no longer let these butchers come to her."
| | I want to warn other women not to travel abroad for cheap surgeries like me. You won't end up looking like a celebrity. And that's true. I regret going there and I regret not having surgery at my home, 'she added. | |
Now Ri is afraid to go to the hospital due to the coronavirus pandemic. She processes wounds that have not yet healed and is waiting for the quarantine to be lifted. "It seems that I will need another 10 thousand pounds for a new operation to put my breasts in order," she concluded.[5]
2019
Allergan recalls breast implants due to oncology risk
On July 24, 2019, Allergan announced that it was withdrawing Biocell textured breast implants and tissue expanders from the market. The reason for the recall was concerns about the emergence of cancer. Read more here.
France has banned textured implants for breast augmentation. They cause a rare form of cancer
In early April 2019, France announced a ban on textured breast augmentation implants. They are suspected to cause a rare form of cancer - breast implant-associated anapestic large cell lymphoma (BIA-ALCL), a subtype of non-Hodgkin lymphoma.
The National Medicines Agency France (ANSM) informs manufacturers of its plans to ban the manufacture, distribution, import, export, promotion and use of textured and polyurethane breast implants. Patients with breast implants have been observed since 2011, in the same year cases of BIA-ALCL cancer began to be monitored. By February 2019, 457 unique cases of cancer associated with breast implants were reported, including 9 deaths. According to the ANSM report, 53 cases of BIA-ALCL were reported among individuals with textured breast implants.
While the ANSM found no causal link between the occurrence of the cancer and the implants, its representatives decided to impose the ban as a "precautionary measure." Breast implant manufacturer Polytech Health & Aesthetics objects to ANSM's findings. A spokesman said the ANSM decision did not have scientific evidence at the heart, but significantly limited plastic surgery options in France. The company also noted that it will continue to sell POLYsmooth and MESMOsensitive microtextured implants.
However, another company, Allergan, pulled its textured breast implants from the European market after certification expired back in December 2018. The French security agency asked for more data on the implants, but the company said it would not be able to provide them before the expiry date.[6]
Breast implants cause cancer
By the beginning of February 2019, 457 cases of rare cancer related to the use of breast implants were detected. Nine of them resulted in deaths. A total of 660 reports of adverse implantation effects were received between 2010 and 2018, including 246 new reports since 2017.
Cases of breast implant-associated anaplastic large cell lymphoma (ALC-CML) have been reported since 2011. The shaft of the new messages may be due to their duplication when sent by patients, doctors and insurance companies, as well as to the active efforts of regulators to inform about existing risks. The experience gained has allowed regulatory authorities to conduct a more thorough analysis of adverse events and take preventive measures.
Regulatory actions in different countries led to the recall of some breast implants. For example, Allergan withdrew textured implants from the European market in December 2018 at the request of French regulators. Post-marketing studies revealed an increase in lymphoma cases in these patients, with malignancies appearing even a few years after surgery.
The variety of devices approved in individual countries, the uneven content of markets, the different approach to reporting of adverse events and the inaccessibility of information on the total number of implants sold make it difficult to compare data and determine risk on a global scale. Given the limitations of medical device reports, regulators are considering other sources of information, including research findings, publications and patient registries, to make this data the basis for prevention measures.[7]
Notes
- ↑ Prices for breast augmentation in Moscow almost doubled
- ↑ Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants - FDA Safety Communication
- ↑ FDA Issues Safety Alert for Squamous Cell Carcinoma and Various Lymphomas in Scar Tissue around Breast Implants
- ↑ FDA: Thousands of new breast-implant-related illnesses reported
- ↑ Mum felt giant 36H boobs pop after flying abroad for a breast reduction
- ↑ Report: France to ban textured breast implants
- ↑ Number of cancer cases linked to breast implants soars
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