Breast Implants Inferno
Katarina Bulatović
—
No one knows how many adverse events with breast implants occur in Slovenia. Doctors often report about them to breast implant manufacturers but not to the competent national authority as they are obliged to by law. Mary paid the price of loosely regulated medical devices. More than once.
Every year breast implants improve the self-image of more than a million women around the world. But some of them could face adverse health consequences later on. Photo: Matej Povše
Her small breasts made her miserable as she was growing up. Wanting to feel better in her own skin, she decided to enlarge them when she turned 19. But since then the life of the now 47-year-old woman, whom we will call Mary, has been plagued by a string of difficulties.
In 1994, she had her first procedure at the private clinic BCB in Ljubljana. »I received only scant information before the operation,« Mary told Oštro.si.
The surgeon Dr. Barbara Čokl chose Nagor implants manufactured by GC Aesthetics. Except the size, Mary did not receive any other information about implants, not even their serial number. The surgeon kept her in the dark about possible complications and only mentioned a chance of bleeding after the operation that would be performed under local anaesthesia.
Then, Mary would not even be able to inform herself about possible complications in Slovenia because the then Medicinal Products Act did not provide for reporting on adverse events with medical devices. Barbara Čokl who retired years ago did not respond to several requests for comment sent via various communication channels by Oštro.si.
Some of the data on adverse events with medical devices and their recalls are made available to the public in the Manufacturer and User Facility Device Experience (MAUDE) database which is maintained by the U.S. Food and Drug Administration (FDA). Since 2012, it contains eight reports on incidents with various types of Nagor breast implants.
The reports submitted to the FDA voluntarily mostly by doctors often included patients describing adverse events like breast lumps, asthma, dizziness, migraine and other types of pain.
International Medical Devices Database (IMDD) compiled by the International Consortium of Investigative Journalists (ICIJ) during a year-long Implant Files investigation into medical devices contains one adverse event related to Nagor breast implants in 2016 in Brazil.
The first incident
Initially after the first procedure Mary was happy. But twelve years later she started to feel stiffness in her breasts. »When I lay on my belly if felt as though I was lying on two rocks. And that hurt,« she remembered.
She went back to the surgeon Dr. Čokl who, according to Mary, reluctantly told her that the shells encasing the implants contracted. This complication, apparently not infrequent, involves an implant changing its shape and possibly causing pain. Consequently, it must be replaced. Dr. Čokl referred Mary to a paid-for infra-red radiation treatment that was supposed to soften the shell. »And that was it.«
Mary paid a substantial amount of money for the treatment which ultimately did not help her. She still had to replace the implants. She found a better-paying job so she could take out a loan for the removal of her implants.
“We don’t know how high the probability of adverse events exactly is because we don’t have all the data. If there’s no registry, we can only guess at what’s happening.”
Her second procedure was carried out by a renown surgeon Dr. Franc Planinšek at the Surgical Centre Rožna dolina in Ljubljana. He recommended Allergan implants, a new product on the market at the time.
The Irish manufacturer guaranteed that it offered the widest selection of implants which were found safe in several studies. Allergan did warn patients, however, that the implants were not guaranteed to last a lifetime.
Forever for ten years
»Ms. Mary, there’s no need to worry, these implants are forever. They’ll outlive you,« Dr. Planinšek convincingly affirmed Mary, according to her. Prior to the procedure, he mentioned that rippling can appear on the implant shell but did not warn her of any other possible complications.
»It wasn’t easy for me to take the decision about the second operation. But I had no reason not to believe him. So I did, completely,« Mary explained.
Again, she was happy after the second procedure. Another 12 years later, in 2018, it all went wrong again. She felt a lump in her left breast: »I was scared to death. I was worried I had cancer. This was especially hard for me because I have two children.«
Following an examination at the Institute of Oncology in Ljubljana, she was thoroughly shaken. They excluded the suspicion of cancer but they did tell her that one of her implants had ruptured.
»How could it rupture when these implants are forever?!« Mary was asking herself. Today, she considers herself naïve but she had no doubts at the time. After all, the surgeon guaranteed that the implants would last a lifetime.
She returned to Dr. Planinšek. Mary said that he immediately blurted out that the warranty lasted just ten years. The period during which Allergan could provide a new implant for the patients – without reimbursing them for the cost of operation – expired. The surgeon gave Mary the manufacturer’s booklet containing this information only after the procedure was finished. Twelve years later, Dr. Planinšek was no longer saying that Mary’s implants were forever.
»If he’d told me that earlier, I could have changed my mind and he would not get his money. He therefore knowingly lied to me before the second operation and kept information that I should have known hidden from me. First, I felt despondent but then, above all, I was enraged,« recalls Mary. »If he’d told me that the implants were not designed to last a lifetime, I would attend regular ultrasound examinations. This is another thing he failed to recommend after the procedure.«
MD Medicina in Ljubljana, the health centre where Dr. Franc Planinšek worked after leaving the Surgical Centre Rožna dolina, informed us that the surgeon stopped working this March. We asked if someone else at the centre, with Dr. Planinšek’s approval, could provide us with a comment. They replied that they forwarded our request to Dr. Planinšek’s assistant who never replied.
In July 2019, Allergan recalled its textured breast implants in all markets across the world – among them also Mary’s model. Oštro.si sent the company detailed questions referring to the type of Mary’s implants, the recall, and also means of contact for patients experiencing issues. Allergan replied they are committed to serving patients and surgeons »in making reasoned decisions«.
The company also wrote that, following the recall of implants, it published instructions for patients on its website and sent clear instructions to surgeons about whom they and their patients could contact in the event of incidents.
A surgeon who wished to remain anonymous, however, told Oštro.si that »after the recall, Allergan’s distributor for the Slovenian market either no longer answered phone calls or the number ceased to exist. Some of us, Slovenian surgeons, were left on our own with the patient and the material.«
Very often doctors report about these adverse events to breast implant manufacturers and not to the competent national authority as they are obliged to. Photo: Matej Povše
A perfectly recalled perfect implant
Dr. Planinšek chose Allergan’s McGhan Soft Touch model for Mary. FDA’s MAUDE database contains 471 patient reports on adverse events with McGhan breast implants since 2010. Four among these reports relate to Mary’s model.
Patients who had this model implanted reported a ruptured breast implant, headaches, breast pain, also cancer. In November 2018, ICIJ revealed that scientific evidence linked breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) to textured implants.
Citing this link as the cause, the French regulator declined to renew Allergan’s certification for two models of textured breast implants, i.e. an official guarantee by a body of the European Commission that a medical device complies with regulations for being sold in Europe. As a result, Allergan recalled these implants across the European Union.
Following years of data gathering, this July the FDA confirmed that Allergan’s textured implants could be linked to BIA-ALCL. Out of 573 reports on patients suffering from this type of lymphoma that the FDA received until now from all over the world, 84% (481) were linked to Allergan’s implants. The FDA also recorded 33 deaths in total and many of these patients had implants by the same manufacturer. According to this data, among 13 women who died and had an implant that could be traced back to its manufacturer, no less than 12 women had Allergan’s implant.
»The safety of patients is of paramount importance to Allargan,« the company informed Oštro.si. It added that the safety of their implants is supported by extensive pre-clinical research, more than ten years of clinical use in the U.S. and Europe, and a host of scientific studies.
From Mentors’ online catalogue. Photo: Mentor
Third and final?
Last September Mary had to undergo a third procedure due to a ruptured implant. She decided to have it performed at Juventina, a private clinic owned by Dr. Uroš Ahčan. Prior to the operation he explained to Mary that it will be a very demanding procedure and warned her of possible complications. »Allergan’s implant which he removed was entirely spilt inside the shell. I can only guess at how long it had been ruptured,« she told as aghast.
She also contemplated to simply have the implants removed but, after consulting the surgeon who told her that removing the implants would destroy her, she decided to replace them. »After having breasts for 25 years, I would be left only with scars.«
Dr. Ahčan chose Mentor breast implants manufactured by Johnson&Johnson.
In the last decade, the U.S. FDA’s MAUDE database recorded several thousand irregularities in patients with various types of Mentor implants, most of them in the last two years. Many patients reported about ruptured implants. Among these, three were the same implants that Mary had implanted; one patient described a ruptured implant, while the other two suffered pain.
The IMDD database compiled by the ICIJ reveals that some of the Mentor models were recalled in France, Canada and the U.S., yet Mary’s model was not among them.
Dr. Uroš Ahčan, also the Head of Department of Plastic Surgery at the University Medical Centre Ljubljana (UKC Ljubljana), has been using Mentor implants consistently for the last 30 years. According to him, during all this time only one Mentor implant ruptured during the implanting procedure.
»Surgeons, just like patients, don’t know anything more about the implant material than what manufacturers tell us. We use the implants that we have good experience with,« he said. In addition to having a wide array of available models, Mentor, one of the leading manufacturers of breast implants, also convinced him with seven clinical studies on the basis of which the company guarantees an almost 100% patient satisfaction with the selection of breast implants.
Uroš Ahčan. Photo: STA
He says that he believes the manufacturer’s studies which were published before it released the implants on the market, but that he does not give any empty promises to his patients. Before they undergo a breast augmentation procedure, he informs each and every one of them, in line with his duties as a medical professional, of possible adverse events. »I tell them, especially younger patients, that they may require corrective surgeries. Implants absolutely do not last a lifetime,« underlined Ahčan.
Elusive number of incidents
In accordance with the law, a health institution must report on adverse events with medical devices which result in death or severe injury of a patient to the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) in 24 hours. It can also report to the manufacturer who must then inform JAZMP of the adverse event.
»In the case of a medical device adverse event, we comply with the law and safety measures,« the public relations office at the UKC Ljubljana assured us. It added that they organise regular training as regards dealing with and reporting on adverse events with medical devices.
According to Dr. Ahčan, however, the Department of Plastic Surgery had not been reporting on breast implant adverse events directly to JAZMP. He explained that they were not informed of regulations and that they do not know enough about the agency’s work in general.
If the Department of Plastic Surgery at the largest Slovenian health institution suspects that complications after the procedure are linked to the patient’s implant, they contact the medical device manufacturer, Dr. Ahčan said. When the implant is removed, they record the procedure in the patient's discharge documents – on paper. Since 2009, they have also been entering this data in the medical centre’s information system.
»The steps of reporting on adverse events are clearly described on our website and doctors’ associations promote reporting with their campaigns. Health professionals who want to acquire information on reporting can easily find it,« says JAZMP.
According to JAZMP, however, the state of reporting of all health professionals, not only doctors, is poor. Many bypass the law by sending adverse events reports to distributors or manufacturers who are obliged to then report to JAZMP but who often fail to do so.
Since 2015, JAZMP was informed only about four adverse events with breast implants. Investigation of one of these incidents is ongoing, whereas in the remaining three cases the causal link between the implant and health issues was not confirmed. Therefore, JAZMP could not send us detailed data about them due to confidentiality.
»These are not accurate numbers,« claims Dr. Ahčan. This year alone, 336 cosmetic and reconstruction surgeries involving breast implants were performed at UKC Ljubljana; in 18 patients these breast implants have been either replaced or removed. Most often this was done due to inflammation of altered position of an implant. In 2019, there were no ruptured implants at UKC Ljubljana, but they did have two cases of a suspected link to BIA-ALCL which were not confirmed.
Last year’s Implant Files investigation by ICIJ prompted the staff at UKC Ljubljana to start recording adverse events with breast implants – again, in a notebook. And only if the patient approves. UKC Ljubljana holds no records as regards the number of adverse events with breast implant in previous years.
UKC Maribor, where the Department of Plastic Surgery has been performing breast reconstruction surgeries for the last ten years, informed Oštro.si that they monitor adverse events with implants but that they do not record them in a dedicated registry. They do not know the exact number of past adverse events.
No registry, no data
»European legislation in the field of medical devices is very accurate and Slovenian legislation has been following it closely, especially since 2006,« said Nada Irgolič, the first director of the Institute for Pharmacy and Drug Research (ZAF), a predecessor of JAZMP. »Reporting, however, is where we hit a snag. Manufacturers, doctors, and patients should know the regulations in detail, but most often they don’t. Legislation is simply dull,« she added.
It is a cause for concern when doctors do not know or have not been informed of the need to report on adverse events. »The interest of everyone involved should be clear and only one: taking care of patient health and safety,« highlighted Irgolič.
JAZMP also wishes that the awareness of the importance of reporting on adverse events would increase. »But the reality is that doctors often don’t know that laws such as the Medicinal Products Act and the Medical Devices Act even exist,« the agency’s press officer wrote in its reply to Oštro.si.
Dr. Uroš Ahčan estimated that there are more than ten million women with breast implants in the world and that the quality of life after the operation has substantially improved for many of them. He underlined that the probability of adverse events is very small and that patients have no reason to panic.
He does agree, however, that more should be done for the safety of patients in the field of medical devices. He thinks that a registry of all cosmetic surgeries is needed because it would allow the monitoring of what happens with the medical device and patient after the procedure.
»We don’t know how high the probability of adverse events exactly is because we don’t have all the data. If there’s no registry, we can only guess at what’s happening,« he added.
Our interviewee Mary is convinced that it is not in the interest of the medical device industry, regardless of technological progress, to manufacture implants with a life span longer than ten years. »They would lose patients who regularly replace their implants and, by the same token, they would lose a lot of money. I find this unacceptable. It feels as though they’re mocking us.«
Dr. Ahčan thinks that, by making a decision to undergo plastic surgery, patients also assume a part of the responsibility. But he also stressed that doctors should always be honest with their patients. »Otherwise, sooner or later they get caught in a loop that makes their lives difficult.«
Nearly three decades after the first procedure, another two surgeries, many sickness leaves, loss of breast tissue, scars, suffering, pain, and overall costs in the amount of EUR15,000, Mary hopes that she will never again have to enter an operation room. But she no longer entertains any illusions. »I accepted the fact that I’ll probably have to undergo another procedure.«
The content of Oštro.si portal is co-financed by the Ministry of Culture of the Republic of Slovenia.