Translation of a-t 2021; 52: 60
 

SPOT ON

IUB BALLERINE INTRAUTERINE COPPER BEAD BALL
...when lawyers answer questions sent to companies

The French medicines agency ANSM has indicated that the notified body* of the manufacturer OCON Medical Ltd. has suspended a CE certificate for the ball-shaped intrauterine pessary IUB BALLERINE "due to unsatisfactory results in the evaluation of the product". ANSM also mentioned 116 reported expulsions related to an estimated 11,000 insertions of the copper bead ball. Users should have the position of the IUB checked on occasion and if they experience any signs of an expulsion such as unexplained pain they should arrange an appointment with their doctor as soon as possible and where appropriate use another method of contraception until the appointment (1).

In response to our inquiry to the German sales partner of OCON, Dr. Schittenhelm Pharma, about the consequences of the ANSM procedure, a lawyer from the European office of the Israeli OCON Group answered (2). She assured us that the product could continue to be used and expressed her expectation "that the administrative inconsistencies regarding the CE certificate will be cleared up soon" along with the "emphasised" plea "NOT [capitalisation in the German original] to make a statement" and to enable the Federal Institute for Drugs and Medical Devices (BfArM) to carry out its own assessment (2).

A little later we received a fax from a German law firm on behalf of OCON. It ended with the formulation that the firm reserved the right "to take legal steps immediately if you publish anything that is not based on facts or which, even if the correct facts are given, would lead to misinformation and deception of the market on the basis of the further circumstances" (3). A request of this type in response to an inquiry submitted in advance of publishing an article reminds us of the processes surrounding the medical device KIJMEA REIZDARM PRO (a-t 2020; 51: 73-4), and we view it as an impermissible attempt to influence our editorial decisions by making threats. In response to our correspondingly short response to the law firm, they attempted to relativise what they had said: we had "obviously completely misunderstood" the law firm's letter. "Your independent reporting was not intended to be influenced in any way" (4). We, however, feel that the initial fax leaves hardly room for misunderstandings.

The medical device IUB BALLERINE is an intrauterine pessary in which 17 small copper balls are strung on a coated shape-memory wire made of the nickel-titanium alloy nitinol and form a spherical shape in the uterus with a diameter of 1.5 cm (5). A similar concept deviating from the typical copper spirals forms the basis of GYNEFIX copper chains (a-t 2015; 46: 22), which contain copper cylinders. Online, OCON reports an expulsion rate of 3.53% for IUB BALLERINE based on an estimated over 100,000 insertions and internal vigilance data (6). We have not received any studies we requested from the company that would enable a robust allocation of the expulsion rates of BALLERINE in direct comparison with other IUP variants. This is also true of the statement by the company lawyer that, according to OCON records, "the IUB BALLERINE does better than the literature on conventional IUPs in every single point of known side effects" (2). We have also been unable to find any verifiable scientific evidence for this in the form of meaningful studies with direct comparisons.

With reference to the temporary suspension of the CE certificate, BfArM informed us that the authorities' risk assessment is not yet complete and that they are "in close contact with the other European authorities with regard to the safety profile of the products" (7).

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