After urinary strips and prostheses for prolapse, these are new medical devices which are the subject of particular monitoring. Should we fear prostheses placed during hernia operations? In a press release published in February 2025, the National Agency for the Safety of Medicines and Health Products (ANSM) announced the establishment of a “market surveillance action” for these prostheses. A decision taken following “international publications” and of “patient declarations” victims of these medical devices.
What is a hernia and what is the role of this prosthesis?
Abdominal hernia is a common and benign pathology, which is mainly located in the groin. “A hernia is annoying but never painful. confirms Dr Mourad Aissat, visceral surgeon at the Turin Clinic and Pitié-Salpétrière, in Paris. Generally, it is accompanied by an exit from the intestine which then comes up against the wall. To strengthen this passage and put the organ back in place, a prosthesis can then be placed. The surgeon then inserts – most often by laparoscopy – a synthetic prosthesis, often made of polypropylene, to maintain the weakened wall.
“The installation of a prosthesis creates inflammation which will generate fibrosis. adds our expert. In an article from ParisianDr Jean-Pierre Cossa, digestive surgeon at the Hernia Institute (Paris), speaks for his part of a “bridal veil” supposed to act as a “patch”, to plug the breach, as it were.
On average, 200,000 interventions of this type take place every day. “There are 500 per day in France on average”
believes Dr Aissat for his part. If in the vast majority of cases, the intervention is successful, unfortunately for some patients, everything does not go as planned…
Patients united in a Facebook group
For some patients, the surgical aftermath is hell. To make themselves heard, they spontaneously organized themselves into a Facebook group called French victims of hernia prostheses.
At the origin of this page, Arnaud Denis, operated on in 2023, suffered immediately after his intervention from various complications: pain, nausea, tremors, neurological disorders… The theater director and actor even admits to having lost 17 kg in a few months. He ends up having his prosthesis removed and explains that he has regained the taste for living. But traumatized by his experience, he encourages other victims to share their ordeal. And receives dozens of comments: “Stabbings in the thigh“, “Nobody warned me“, “Impossible to remove it“… In total, around thirty people (at least) have suffered from the fitting of this type of prosthesis since 2020. They say they live with daily pain, which is very difficult to bear.
Health authorities announce reinforced surveillance for these implants
These testimonies as well as certain studies on the subject push the ANSM to react. Last February, it announced increased monitoring of so-called “parietal reinforcement” implants, while recognizing a probable under-reporting of adverse effects. “Since the 2000s, these implants have replaced traditional sutures; personally, I have been carrying out this type of operation for twenty years.” adds Dr Aissat.
But since 2017, these devices have been classified “high risk”. And for good reason: 10 to 12% of patients feel persistent pain three to six months after the operation, adds Dr. Cossa. A minority (between 0.5% and 6%) see this pain alter their daily life, in particular because of nerve damage or scar fibrosis.
How to manage this pain?
According to Dr. Aissat, pain can also have different causes.
“This disabling pain can be linked to the type of prosthesis, the location of the hernia, the surgical method chosen, the type of attachment used: glue, staples, wires… What must nevertheless be remembered is that it is a very safe intervention, these cases of chronic pain, beyond the post-operative period of two months, are on the margins..
Another possibility explaining this pain: rare allergies to the material, or even a serious autoimmune reaction. The case of a patient in 2021 highlighted a possible link between polypropylene implants and adjuvant-induced inflammatory autoimmune syndrome (ASIA). Among the symptoms: diffuse pain, cognitive disorders and muscle weakness.
The expert recommends that affected patients consult a doctor specializing in the issue in order to determine whether the pain is related to the surgery.
“First of all, it is essential to know if the pain described is linked to the surgical procedure and if it is not something else, hip pain caused by osteoarthritis for example. And if the surgery is the cause of the pain, it is important to listen to the patient and try to relieve them with medication.”
Can implants be removed? “This can hardly be done, because their installation generates fibrosis to close the hernia. This scar tissue, composed of collagen, is very strong” admits the surgeon.
ANSM wants answers, patients demand more transparency
For the ANSM, the challenge now is to collect as much information as possible, before a major consultation planned for June with manufacturers, doctors and patients. “It is important that patients get involved“, insists Gwenaëlle Even, deputy director in charge of medical devices at the ANSM.
Arnaud Denis, whose Facebook group now has several hundred members, hopes to participate. He deplores the lack of information given to patients, particularly on the real risks, but also the absence of an implant card issued after the operation. “I was only told about the pain, never about the rest” he says indignantly. Not sure he would have chosen to have an operation if he had been aware of all these risks.