The US Food and Drug Administration are conducting an enquiry into adverse patient reactions to materials and medical devices, including breast implants. They have advised that they will consider patient responses to the silicone contained in breast implants at a special hearing on Breast Implant Safety due to take place on March 25th-26th.
The FDA have made their strongest statement yet regarding breast implants:
“We believe the current evidence, although limited, suggests some individuals may be predisposed to develop an immune/inflammatory reaction when exposed to select materials”, the FDA said in its statement.
Last year the International Consortium of Investigative Journalists, in an extensive report on the medical device industry, examined regulators’ refusal to recognise adverse reactions to these devices among patients, including Breast Implant Illness, an ailment reported by many implant patients characterised by chronic fatigue, muscle pain and cognitive difficulties.
On September 14th 2018 the MD Anderson Cancer Centre reported that a study found elevated risks of Autoimmune Disease among patients with breast implants.
To clarify their position the FDA stated:
“While the FDA doesn’t have definitive evidence suggesting breasts implants are associated with these conditions, we are looking to gain a fuller understanding of this issue to communicate risk, minimise harm and help in the treatment of effected patients”.
At Avenue Plastic Surgery, we have long been supportive of women who have symptoms that they believe may be due to their silicone implants. We have found that symptoms such as “brain fog, joint pains, fatigue and digestive disturbances” often improve following removal of the silicone implants. Because silicone is soluble in fat and not in water, it is difficult for the body to remove any absorbed silicone even after removal of the silicone implants. For this reason we have instigated a detox program designed to eliminate any retained silicone.
There is a great deal of emotion surrounding this subject and it is likely that many women’s symptoms are amplified by psychosomatic factors. From our experience, it would appear that some implants are more inclined than others to leak silicone. The leaking of silicone (or gel bleed) can occur even if the implant has not ruptured. Even when silicone implants have ruptured, many women do not develop symptoms of Silicone Implant Illness. Other women develop symptoms soon after insertion so there is probably a genetic variation in a woman’s ability to process silicone.
And what about Saline Implants?
We have inserted more than 5000 of these implants and we have never seen a case of silicone associated Breast Implant Illness associated with smooth-walled saline filled breast implants.