A recent report has revealed that local health authorities have yet to obtain information on more than 52,000 patients who received Allergan's breast implants, which can cause rare cancers.
Rep. Yoon Il-kyu of the ruling Democratic Party of Korea released the data of patients who received Allergan's Biocell textured implants, submitted by the Ministry of Food and Drug Safety (MFDS) on Monday.
The report comes after Allergan issued a worldwide recall of Biocell textured breast implants and tissue expanders, which are linked to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
As of Sept. 30, 97,097 textured breast implants were on the market. However, the report showed that the ministry has information only on 44,478 patients, 45.8 percent of the artificial breasts distributed.
Such lack of data has brought on severe criticism as the ministry had designated textured artificial breast as a medical device that needs to be tracked since November 2014.
According to the regulation, manufacturers and other handlers have to submit related records and data every month. Also, if there is a request from the MFDS director, medical institutions have to submit the data within 10 days of the request.
Despite such regulations, the ministry never collected patient information from the users and started collecting them only after the Allergan health controversy arose in July. The data also showed that the ministry had never collected data on other 52 medical devices designated for tracking.
"I don't know why the ministry designated the medical device for tracking if they had no intention of doing so," Yoon said. "As the ministry has never collected any data after designating the devices, it is questionable if the government is willing to manage the system."
All patients, including Allergan receivers and others who underwent textured breast implants, must be tracked, and the ministry has to inform each patient of the current situation and countermeasures actively, Yoon added.
The DPK lawmaker also stressed that the ministry has to start collecting and computerizing the patient information of all medical devices to avoid a second Allergan crisis.
Meanwhile, Allergan agreed to provide full compensation for the medical expenses of patients who are diagnosed with implant-associated anaplastic large cell lymphoma (BIA-ALCL) after using Allergan's textured implants. The ministry and Allergan came up with a compensation plan for people who received the company's textured implants.
The compensations will vary depending on the types of patients – patients diagnosed with BIA-ALCL, those with suspected BIA-ALCL symptoms, and those who wish to remove the breast implant to prevent rare cancer.
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