1, what is the harm of breast augmentation with prosthesis?
Cancer patients often use rough prostheses.
The FDA began to pay attention to this issue on 20 1 1. On March 2 1 this year, the US Food and Drug Administration (FDA) issued a statement, pointing out that a new rare T cell lymphoma is called breast prosthesis-associated anaplastic large cell lymphoma (BIA-ALCL). So far, nine death reports caused by this disease have been submitted to the FDA.
The connection between prosthesis and ALCL was first confirmed in 20 1 1. However, due to the limited number of cases, it is impossible to determine the correlation between breast augmentation and cancer, and it has not been taken seriously.
Since 20 1 1, FDA has strengthened its understanding of this relationship, and now it has reached an agreement with the World Health Organization to name BIA-ALCL as a rare T-cell lymphoma, which will progress after breast prosthesis surgery.
According to the information on the FDA website, "all the information so far shows that compared with women who have never had breast augmentation surgery, women who have had breast augmentation surgery have a lower risk of developing ALCL. Most of anaplastic large cell lymphoma associated with breast prosthesis will be removed and covered by prosthesis, and some cases will also receive chemotherapy and radiotherapy.
The FDA is currently unable to determine the exact number of BIA-ALCL cases; However, this disease occurs more in people with rough texture/surface than in people with smooth surface.
As of February 1 day, FDA indicated that it had received 359 reports of BIA-ALCL medical devices, including 9 deaths. Of these reports, 2,365,438+0 included information about the surface characteristics of the prosthesis; 203 cases reported that the surface of prosthesis was textured, and 28 cases reported that the surface of prosthesis was smooth. Of the 359 reports, 3 12 has information about the types of prosthesis filling; 186 cases were filled with silica gel, and 126 cases were prosthesis with saline bag.
FDA suggested that clinicians should continue to provide routine examination and support for their breast prosthesis patients. When BIA-ALCL syndrome occurs, patients with delayed and persistent hydrops treated with prosthesis need surgical repair. Preventive breast prosthesis removal is not recommended for patients without common symptoms such as pain, swelling or asymmetry.
After breast augmentation, the prosthesis should be checked regularly.
"We must first make it clear that this T-cell lymphoma is a blood disease, not breast cancer. The known patients are all Europeans and Americans, and there are no Asians yet." Luo Shengkang introduced. This is very different from the adverse events of breast cancer caused by the injection of Ogilvy, a breast augmentation material, in earlier years in China. The FDA's reminder occurred on the regular prosthetic breast augmentation materials.
According to the data released by the American Plastic Surgery Association, about 400,000 women in the United States have breast implants every year. This number is millions all over the world. Luo Shengkang said that compared with this data, the number of more than 300 cancer patients is not large, and the base is huge, but we still have to keep a clear head.
BIA-ALCL is a newly discovered cancer species. Luo Shengkang said that quite a few doctors don't know much about it. Relevant data in the United States show that the average incubation period of this cancer is 8 years, and the longest is 28 years. Most of the new cases were women who had breast implants 10 years ago.
After the FDA issued a warning, more and more doctors are now aware of the relationship between prosthesis and cancer. However, for those women who have done breast augmentation with prosthesis, Luo Shengkang reminded that we must always pay attention to whether there is persistent swelling and pain around the breast where the prosthesis is implanted, the breast suddenly increases, and there is liquid in the breast. , and regularly go to the hospital for professional examination.
For those women who haven't done it yet but are still hesitating, Luo Shengkang stressed that they must choose regular hospitals and doctors and follow the doctor's advice.
2. Related issues about breast augmentation.
1. Which breast augmentation method is the safest?
At present, there are two recognized safe breast augmentation methods: prosthesis breast augmentation and autologous fat transplantation breast augmentation. However, autologous fat transplantation is easy to absorb and calcify, so it is not widely used in clinic.
More than a decade ago, the popular method of breast augmentation by Ogilvy injection in China was banned because of safety problems. Other methods, such as medicine, massage, acupuncture and dietotherapy, lack scientific basis and have unreliable or unsafe curative effects.
2. Can the artificial silicone breast prosthesis be placed in the body for life?
Although the artificial silicone breast prosthesis is designed and produced according to the material standard of long-term implantation in human body, the manufacturer does not guarantee its lifetime use because of too many factors affecting its life. Therefore, in some special cases, it may be necessary to replace the prosthesis. At present, there is no regulation on the longest service life of artificial breast prosthesis in human body, but it is necessary to review the quality and safety of prosthesis regularly (about 7-8 years after breast augmentation).
3. Will breast augmentation affect the diagnosis or screening of breast cancer?
Although the existence of breast prosthesis may block some breasts in molybdenum target X-ray examination, it has no effect on most examination methods such as B-ultrasound, infrared ray, ct and nuclear magnetic resonance. According to a large number of foreign literature statistics, there is no report that the diagnosis of breast cancer is delayed because of the existence of prosthesis. (Reporter Li _)
3. Precautions for Prosthetic Breast Augmentation
(1) bleeding and hematoma: avoid menstrual surgery, preoperative blood cell examination, bleeding and clotting time detection, and apply vitamin K 10mg/ day before operation.
(2) Abnormal morphology: improper selection of breast prosthesis and insufficient cavity stripping will lead to poor breast morphology. The preventive measures are to design the breast augmentation capsule cavity before operation, select the appropriate prosthesis and fully peel it off to prevent such complications.
(3) Breast droop: Too much peeling of breast augmentation capsule cavity is caused by cleavage under the breast. Most of these complications occur when the prosthesis is placed under the breast or the breast skin is slack and the prosthesis is too large.
(4) Upper arm pain: caused by intercostal nerve compression. Although rare, it is difficult to treat, and can be treated by physical therapy, nerve block and other methods.
(5) Infection: Very rare. In severe cases, it causes extensive infection in the pectoral muscle space, so it can only be solved by removing the prosthesis, debridement and drainage.
(6) Pneumothorax or empyema: A very rare complication, which can cause complications such as pneumothorax or empyema because it enters the chest when separating the pectoral muscles. The prevention method is to separate the pectoral muscle under direct vision and separate it on the surface of the rib. Do not separate the pectoral muscles between the ribs to avoid entering the chest cavity.