Taiwan Women’s Link and Democratic Progressive Party Legislator Lin Shu-fen (林淑芬) yesterday urged the Ministry of Health and Welfare to inform people about the health risk of breast implants.
The US Food and Drug Administration in 2011 identified a possible link between breast implants and the development of anaplastic large cell lymphoma (ALCL), Women’s Link founder and standing director Huang Sue-ying (黃淑英) said.
The breast implant-associated ALCL (BIA-ALCL) is not breast cancer, but a cancer of the immune system, she said, adding that it is mostly found in scar tissue and fluid near implants.
Photo: CNA
As of September last year, the US agency had received 457 unique medical device reports that meet the pathologic criteria of BIA-ALCL, including nine resulting in death, and most data suggest that BIA-ALCL occurs more frequently after placement of breast implants with textured surfaces than those with smooth surfaces, Huang said.
The UK Medicines and Healthcare products Regulatory Agency until September last year received 57 reports of ALCL in patients with breast implants, of which 45 cases meet the WHO diagnostic criteria for BIA-ALCL, and the country launched a Breast and Cosmetic Implant Registry to collect data and detect early warning signs about people with implants, Lin said.
Data from Australia and Canada showed that 393 people in Taiwan were diagnosed with ALCL in 2016, but there are no data that can help establish a link with breast implants, Huang said, adding that the government does not monitor the safety of breast implants and there is no registry.
The Taiwanese Food and Drug Administration only issued a document informing the Taiwan Society of Plastic Surgery, the Chinese Society of Cosmetic Surgery and Anti-aging Medicine, and others of the risks in 2011 and 2017, Lin said.
Doctors were asked to evaluate and observe the situation, and inform authorities about the association between ALCL and breast implants, but the agency has not conducted a survey to assess the actual situation, she said.
The government should launch a national breast implant registry to collect data on the link between cosmetic surgery and ALCL, as well as other health risks, Lin and Huang said.
People should also be informed about the health risks in the consent form given to patients before breast implant surgery.
Department of Medical Affairs official Liu Yueh-ping (劉越萍) said that clinics and hospitals are required to register the product codes for breast implants, but the data are kept at medical facilities.
The health ministry would consider adding information about ALCL to consent forms and ask specialists to assess the link between ALCL cases and breast implants in Taiwan, she said.
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