{"id":176,"date":"2019-10-28T10:08:29","date_gmt":"2019-10-28T14:08:29","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=176"},"modified":"2019-10-28T10:08:29","modified_gmt":"2019-10-28T14:08:29","slug":"fda-proposes-labeling-recommendations-for-complications-linked-to-breast-implants","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2019\/10\/28\/fda-proposes-labeling-recommendations-for-complications-linked-to-breast-implants\/","title":{"rendered":"FDA Proposes Labeling Recommendations for Complications Linked to Breast Implants"},"content":{"rendered":"<p>On October 24, 2019, the Food and Drug Administration (FDA) announced new draft guidance entitled \u201c<a title=\"Breast Implants - Certain Labeling Recommendations to Improve Patient Communication\" href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/breast-implants-certain-labeling-recommendations-improve-patient-communication\" target=\"_blank\" rel=\"noopener noreferrer\">Breast Implants\u2014Certain Labeling Recommendations to Improve Patient Communication<\/a>.\u201d The draft guidance \u201ccontains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants.\u201d<\/p>\n<p>In its announcement, FDA noted that it has received \u201cnew information pertaining to risks associated with breast implants, including breast implant-associated anaplastic large cell lymphoma\u201d and additional illnesses attributed to breast implants. Complications related to breast implants have been widely reported over the last year, with other symptoms, including increased presence of autoimmune disease in women who have received breast implants, as well as muscle and joint pain, fatigue and weakness, and certain cognitive difficulties. These proposed labeling requirements also follow FDA warnings issued to two implant manufacturers who had failed to carry out adequate postmarket surveillance of the implants as a condition of their approval, as well as an FDA request that another manufacturer recall certain textured breast implant products.<\/p>\n<p><a href=\"https:\/\/www.duanemorris.com\/alerts\/fda_proposes_labeling_recommendations_complications_linked_breast_cancer_1019.html\">View the full <em>Alert <\/em>on the Duane Morris LLP website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On October 24, 2019, the Food and Drug Administration (FDA) announced new draft guidance entitled \u201cBreast Implants\u2014Certain Labeling Recommendations to Improve Patient Communication.\u201d The draft guidance \u201ccontains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants.\u201d In its announcement, FDA noted that it has received \u201cnew information &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2019\/10\/28\/fda-proposes-labeling-recommendations-for-complications-linked-to-breast-implants\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA Proposes Labeling Recommendations for Complications Linked to Breast Implants&#8221;<\/span><\/a><\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[412,392,29,34,411,371,410],"ppma_author":[521],"class_list":["post-176","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-breast-implants","tag-dana-ash","tag-fda","tag-labeling","tag-nick-centrella","tag-products-liability","tag-sharon-caffrey"],"authors":[{"term_id":521,"user_id":6,"is_guest":0,"slug":"duanemorris3","display_name":"Duane Morris","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/843ff6e7a8fe5fc92109b47a45f34b6cf0ea499e6e788db23456c838b0ae6747?s=96&d=blank&r=g","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/176","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/comments?post=176"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/176\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=176"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=176"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=176"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=176"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}