A rare type of immune system cell cancer called Anaplastic Large Cell Lymphoma (ALCL) is linked to silicone breast implants. ALCL is a lymphoma and not cancer of the breast tissue. In women with breast implants, ALCL was found adjacent to the implant itself and contained within the fibrous capsule. The condition presents usually with a late onset seroma (fluid collection around the implant) some years after surgery, and is usually treated with capsulectomy alone, though some cases require chemotherapy. The first case was reported in 1997, yet it is important to note that breast implants have been used since 1962, with current numbers showing there are over 10 million women in the world with breast implants. The current risk of developing ALCL associated with breast implants is placed at 1:24,000.
As of September 30, 2017, the FDA in USA had received a total of 414 medical device reports (MDRs) of BIA-ALCL, including the death of nine patients. 272 of the 414 reports included information on the surface information of the implant at the time of the report, including 242 with textured surfaces and 30 with smooth surfaces. 413 of the 414 reports included information on implant fill types. Of these, 234 reported implants filled with silicone gel and 179 reported implants filled with saline.
As of September 2018, MHRA in the UK has received 57 reports of ALCL in patients with breast implants, 45 of which meet the WHO diagnostic criteria for BIA-ALCL. In cases of ALCL in women with breast implants reported to MHRA there have been 3 deaths. Only 1 of these is confirmed to meet the diagnostic criteria for BIA-ALCL. The other two deaths did not meet the diagnostic criteria. https://www.gov.uk/guidance/breast-implants-and-anaplastic-large-cell-lymphoma-alcl
There is increasingly accepted hypothesis that bacterial contamination introduced at the time of implant surgery may over time lead to a biofilm that triggers an inflammatory and immune response which in conjunction with a patient’s genetic pre-disposition may lead to BIA-ALCL. The creation of a biofilm can be reduced with the use of the 14-point plan. Texturing may contribute to increasing an inflammatory response by increasing the surface area.
Breast implant related Anaplastic Large Cell Lymphoma (BI-ALCL) remains a rare condition that has been identified in 650-700 patients worldwide. It appears that there are at least 57 cases identified in the UK. All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants.
Breast Implant Illness (BII)
Breast Implant Illness is a condition that consists of a very broad range of non-specific symptoms such as hair loss, brain fog, general fatigue, fibromyalgia and other associated conditions such as ME, irritable bowel syndrome, various skin conditions and autoimmune conditions such as lupus, rheumatoid, SLE and Raynaud’s.
Many of these patients have tried a range of strategies to overcome their ailments, including nutritional advice, changes in diet and a variety of lifestyle changes. Most of them have reached the conclusion that their breast implants are responsible for their malaise and requesting explantation.
Though BII has been recognized as a condition that affects some patients with breast implants, currently there is lack of good data and no causal association has been demonstrated in literature so far. The variety of generalised symptoms reported have made it difficult to ascertain the ‘true’ features of the illness and hence an objective diagnosis can be difficult. It is believed that a in some patients, a psychological pre-disposition may lead to development of symptoms. Explantation (removal of implants) appears to only work for 50% patients.