Democratic Progressive Party Legislator Lin Shu-fen (林淑芬) and Women’s Link founder Huang Sue-ying (黃淑英) yesterday called on the government to ban transvaginal mesh implants and establish a registry system for medical implants.
Transvaginal mesh implants are used to repair weakened or damaged tissue in women’s bladder or pelvic areas, usually in cases of pelvic organ prolapse (POP) or stress urinary incontinence (SUI).
The US Food and Drug Administration (FDA) cleared the first surgical mesh product specifically for use in SUI cases in 1996 and for POP cases in 2002.
Photo: Tu Chien-jung, Taipei Times
However, complications including chronic pain, vaginal bleeding or discharge, pain during intercourse, urinary problems and exposure of the mesh through the vagina have been reported in many nations, triggering lawsuits in several countries.
New Zealand and Australia last year banned the use of the implants, while the UK enacted a temporary ban, and in April, the FDA ordered manufacturers to immediately stop selling and distributing surgical mesh for anterior compartment prolapse repair, citing safety concerns, Huang told a news conference at the Legislative Yuan in Taipei.
“Compared with the proactive measures taken in other nations, Taiwan is still silent on the issue,” she said.
The Ministry of Health and Welfare only changed the classification of transvaginal mesh to a third-class “high-risk” medical device in July 2017, requiring manufacturers to submit a safety report on their products every six months, Huang said.
“The government is very irresponsible. Its relaxed attitude toward regulating the manufacturers, neglecting the health risks to women who have had such implant surgery,” Lin said.
Reports of complications associated with transvaginal meshes in Taiwan increased from 59 cases in 2013 to 303 cases in 2017, and some patients might not even be aware that their discomfort could be the result of complications caused by the implants, she said.
The government needs to establish a medical implant registry system, and require that patients be informed about the possible risks associated with transvaginal meshes before having such surgeries.
Food and Drug Administration section chief Tu Pei-weng (杜培文) said the agency was aware of international safety warnings about the products and had adjusted the risk management measures on such implants.
However, a meeting of specialists that the agency held in March suggested that the reported problems in Taiwan stemming from such procedures were more due to physicians’ training and patient screening than with the products, she said.
The specialists at the meeting said that banning the use of transvaginal mesh implants would hurt women with SUI or POP, as there is no better alternative treatment, Tu said.
Given patient personal data protection regulations, registry systems are usually voluntary, not compulsory, she said.
An amendment to the Regulations for Governing the Management of Medical Devices (醫療器材管理法) that is under review at the Legislative Yuan would require the tracking of high-risk medical devices from the manufacturers, Taiwan’s Food and Drug Administration said.
A study published by online booking platform Expedia revealed searches for travel to Taipei have ballooned 2,786 percent following the lifting of COVID-19 pandemic travel restrictions due to the city being a “designation dupe” for Seoul. The TikTok trend for duping — referring to substituting a designation for a more inexpensive alternative — helped propel interest in Taipei, it said in a consumer survey titled “Unpack ‘24,” which was conducted from September to October in 14 countries. Location dupes are “every bit as delightful as the tried-and-true places travelers love,” Expedia trend tracker Melanie Fish said of the year’s popular alternatives, which
SAFETY IN REGULATION: The proposal states that Chiayi should assess whether it is viable to establish such a district and draft rules to protect clients and sex workers The Chiayi City Council passed a motion yesterday to assess the viability of establishing a regulated red-light district. The council yesterday held its last session of the year, at which its fiscal 2024 budget was approved, along with 61 other proposals. The proposal to assess the viability of establishing a red-light district was put forward by independent Chiayi City Councilor Molly Yen (顏色不分藍綠支持性專區顏色田慎節). The proposal cited 2011 amendments to the Social Order Maintenance Act (社會秩序維護法), which stipulate that city and county governments can pass autonomous regulations on the sex trade to manage the industry and guarantee industry workers’ rights. A ban on the
A small-scale protest that called on the government to cancel its plan to welcome Indian migrant workers in a bid to tackle Taiwan’s labor shortage was held in Taipei yesterday. During the protest, comprised of a few dozen people staged in front of the Presidential Office on Ketagalan Boulevard, the protest’s chief initiator, a woman identified only as “Yuna” said they wanted the central government to reconsider allowing migrant workers from India to enter Taiwan. Most people in Taiwan had little knowledge about the potential plan to allow in Indian migrant workers until a report in the media last month, she
STABILITY AND CHANGE: Flagging in recent polls, Ko this week pledged to maintain President Tsai’s foreign policy, with an emphasis on improving China relations Taiwan People’s Party (TPP) Chairman and presidential candidate Ko Wen-je (柯文哲) yesterday reiterated that he is “deep-green at heart” in response to accusations that he is pivoting his campaign to align closer with the ideology of the Democratic Progressive Party (DPP) in the face of flagging polls. Ko made the remark at an agricultural policy conference in Taipei, repeating his comments from an interview with CTS News a day earlier. Ko told the CTS host that he would continue to pursue President Tsai Ing-wen’s (蔡英文) national defense and foreign policy in general, but with an emphasis on establishing a rapport with
RSS