In this society it is difficult to not let the ideals of Western beauty to influence you. Because of this, many women choose to undergo breast implant surgery in order to feel better about them or to help with necessary reconstruction after cancer treatment.
Anaplastic Large Cell Lymphoma (ALCL)
Currently 400 reports discuss patients who have developed a rare blood cancer (not breast cancer) called anaplastic large cell lymphoma (ALCL) after receiving breast implants, with nine who actually died. According to the American Society of Plastic Surgeons, about 400,000 breast implant procedures were executed in 2017. The Food and Drug Administration (FDA) has been investigating reports that link the condition to the elective surgery. In 2016 the World Health Organization assigned ALCL as a type of T-cell lymphoma.
Breast Mastitis or ALCL?
Initial symptoms of ALCL generally show up as a breast mastitis infection consisting of extreme pain, swelling, and itching. And while it may seem that you are okay, it can take around 10 years after the implant is placed before it develops. Though it is usually found around the implant, it can spread.
The Issue with Textured Implants
The current estimate for those whom it affects has been placed between 1 in 3,817 to 1 in 30,000. And although the FDA believes that textured implants are more likely to cause ALCL, smooth implants have also been shown to do the same. Also to note is that doctors seem to prefer the textured implants as they reduce risk for capsular contracture. It is their stationary quality though that may increase the risk.
Determining Real Statistics
Breast implant manufacturers are required to report any issues that are associated with the medical devices to the Manufacturers and User Facility Device Experience (MAUDE) database. Initially they were grouping occurrences into one report, making it difficult for MAUDE to determine the exact number of individuals who had developed cancer from the implants. Due to this, in 2017 the FDA ordered that the manufacturers go back and file individual reports for each patient’s injury. As of September 30, 2017, the FDA had received a total of 414 reports, including nine fatalities. Of the 272 reports that included data regarding surface information, 242 occurred with textured implants, while only 30 occurred on smooth implants. Of the 413 reports that were given with implant fill type, 234 were of silicone gel-filled implants and 179 were of saline-filled.
FDA to Hold Hearing on Breast Implant Safety & Regulations
In September 2018 a large group of breast implant patients who have become advocates for public health visited Washington D.C. in an effort to lobby the FDA to require stricter regulations, testing, and reporting and to ban textured breast implants all together. In early 2019 the FDA will hold a committee hearing regarding breast implant safety in order to address the issues asserted and to decide on any other actions or regulations that are necessary in order to better protect public health.
Posted in: Medical Malpractice