Breast implants and a rare form of cancer

A very common type of bad implant, used by millions of women around the world, is at the center of new lingering suspicions about its ability to significantly increase the risk of cancer. The problem had already been raised in the past, but has come back in recent weeks in the light of recent events following new investigations in France and some journalistic investigations, such as the one recently published by the guardian. Many surgeons have already decided to suspend the use of prostheses in the expectation of further research, which could take years, given the large number of bad reconstruction operations performed around the world. .

The increased risk of tumors consists of rough ("textured") prostheses, the most used in most countries of the world for bad reconstruction. Their surface is rough and inhomogeneous: many surgeons believe that they give a more natural result and fewer complications, for example with regard to the displacement of the prosthesis in the bad, which reduces the risk of resorting to new corrective and invasive interventions. The problem is that we have been suspecting for some time that there is a correlation between raw prostheses and anaplastic large cell lymphoma (CLLA), a rare form of lymphoma affecting T cells, a type of immune system cell.

During bad reconstruction procedures – usually performed for aesthetic reasons on patients who have undergone surgery to remove a tumor or to increase its size – the prostheses are inserted into the pectoral muscles, under the chest, so that to make it more inflated. The body recognizes the prosthesis as a foreign body and activates the immune system, which attempts to neutralize it by an inflammation of the surrounding tissues. The process leads to the formation of an internal scar, a layer of fibrous and compact tissue, which surrounds the entire prosthesis. In rare cases, in the space separating the scar from the prosthesis, develops a form of ALCL known as BIA-ALCL (BIA is the acronym for "badociated bad implant", literally "linked to the bad implant").

In blue the prosthesis, in red the fibrous tissue, the part in light blue is the capsule where develops the ALCL (Guardian)

Tumor cells accumulate in fluids located between the prosthesis and the scar, but in some cases they can move to other parts of the body, resulting in extensive and potentially dangerous lymphoma. The first symptoms are usually abnormal swelling of the bad and a dull ache, which becomes acute during particular movements or when taking positions compressing the room.

Removing the prosthesis and cleaning the gap between the implant and the scar can solve the problem by offering total recovery. The problem is that this condition is not always diagnosed quickly, which increases the risk of developing a larger tumor and the need for heavier treatments such as chemotherapy.

To date, there is no reliable record of how the problem of gross dentures is expanding and of quantifying risk factors. According to the latest surveys, based on the direct feedback provided by surgeons, there were at least 615 BIA-ALCL cases worldwide, 16 of which would have resulted in patient deaths.

In France, the National Agency for the Safety of Medicines and Health Products (ANSM), the government agency responsible for the safety of medicines and health products, invited surgeons to preferentially use plain dentures. waiting to have new items on the roughs. It is estimated that in France 85% of the new prostheses used are raw. Next February, ANSM will organize a meeting with different experts and patients to define new rules for the use of prostheses. The decisions taken in France could be reflected in many other countries.

In the United Kingdom, writes guardian, confirmed lymphoma cases related to new bad implants were 45, with the death of at least one patient. The data are currently approximate, as is the estimate that the risk of developing a BIA-ALCL would be 1 for 24,000 patients. In the United States, where the use of raw prostheses is widespread, it is estimated that there have been at least a thousand cases and that there are thousands of others undiagnosed .

Studying the consequences of surgical treatment on such a large scale is not easy, but many criticize the slowness with which the problem has been treated by health authorities. The first suspicions about rough dentures were raised about 20 years ago. In the UK, the possibility of a link between a particular form of lymphoma and bad reconstruction operations was evoked.

In 2011, the Food and Drug Administration (FDA), the US government agency responsible for food safety and medication, reported an abnormal increase in the number of cases of SLAAC in patients with bad implants. Two years later, a first census had identified at least 130 cases worldwide, with an increase in the following years, up to 359 detected in 2017 by various scientific researches. A year ago, the EU's Scientific Committee on Health and Emerging Risks (SCHEER) invited the scientific community to further their research on the relationship between bad implants and LAGCs.

The Ministries of Health of the European Union, including that of Italy, have been working together for several years to monitor the situation and keep more reliable records of new cases of CLA. The Italian Ministry of Health has seen a significant increase in the number of new cases since 2015, year of the issuance of a circular inviting health staff to notify more accurately their diagnoses. Until last spring, 30 cases of BIA-ALCL were discovered in Italy. An initial statistical survey of data retained by the ministry places the incidence of the disease in 2.8 cases per 100,000 at-risk patients in 2015. Symptoms can occur between one and 22 years from the time of the year. 39, with an average delay of 6.8 years.

In Italy, about 49,000 bad implants are implanted each year, so the number of cases of BIA-ALCL should remain limited, according to the ministry. However, the data could change in the future as the follow-up time of patients undergoing operations for new implants will be extended.

The number of cases of BIA-ALCL continues to be extremely low, as well as its incidence, but that does not of course mean that we should stop doing research on the subject. The reduced incidence makes it more difficult to identify a clear correlation between raw prostheses and the development of this type of lymphoma.

Many patients who have told their stories to guardian, complain of not being properly informed before submitting to the operation. They claim to have not received enough information about the risks, although there is suspicion of gross dentures for nearly 20 years, but for a very limited number of ALS cases. Smooth prostheses and techniques to perform the operations have also evolved, making alternative solutions to the more reliable raw prostheses, but these continue to be more prevalent.

Allergan, one of the leading manufacturers of bad implants, said to be "fully engaged" in studying the problem, to better understand risk factors and to provide more comprehensive information to future patients. The pharmaceutical company is also experimenting with new materials and solutions that could make things better. However, research requires time and money and will not result in major changes in the near future. Mentor, another major manufacturer of prostheses, explained that raw products offer many benefits, starting with greater stability of implants, reducing the risk of prostheses moving and requiring new, rather invasive procedures. The risk of such inconvenience is much higher than that of obtaining the BIA-ALCL, at least on the basis of data available to date.