果凍矽膠隆乳的歷史
1976 美國國會通過法案,將乳房植入物歸類為第二類的醫器材,同意上市前告知即可 (premarket notification)
1988 美國食藥署將乳房植入物改歸類為第三類的醫療器材,必需進行上市前的臨床試驗與核可
1991 四月:美國食藥署發佈命令,Congress passed the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act. Breast implants were placed into Class II and reviewed through the premarket notification [510(k)] process.
1988In response to emerging safety concerns, the FDA re-classified breast implants to class III devices (requiring premarket approval). However, in accordance with the law, they continued to be reviewed through the 510(k) process until the FDA issued a rule calling for submission of premarket approval applications (PMAs).
1991 - AprilThe FDA issued a final rule calling for submission of PMAs for silicone gel-filled breast implants.
1991 - NovemberThe FDA held an Advisory Panel meeting to discuss several PMAs for silicone gel-filled breast implants. While the panel concluded that the manufacturers had failed to provide adequate safety and effectiveness data for their implants, they unanimously recommended that the FDA permit the implants to remain on the market.
1992 - JanuaryThe FDA announced a voluntary moratorium on silicone gel-filled breast implants, requesting that manufacturers stop supplying them and surgeons stop implanting them, while the FDA reviewed new safety and effectiveness information that had been submitted.
1992 - FebruaryBased on new information, the FDA held a second Panel meeting to re-evaluate the safety of silicone gel-filled breast implants. This time the panel recommended that silicone gel-filled breast implants be removed from the market pending further evaluation of the new data.
1992 - AprilThe FDA concluded:
1992 - JulyThe FDA approved Mentor's Adjunct Study protocol for its silicone gel-filled breast implants for reconstruction and revision patients only.
1998 - MarchThe FDA approved Allergan’s (formerly Inamed) Adjunct Study protocol for its silicone gel-filled breast implants for reconstruction and revision patients only.
1998 - JuneThe FDA approved Allergan’s investigational device exemption (IDE) study (i.e., Core Study) for its silicone gel-filled breast implants for a limited number of augmentation, reconstruction, and revision patients at a limited number of sites. This is the Core Study for submission P020056.
2000 - MarchThe FDA held an Advisory Panel meeting to discuss three saline-filled breast implant PMAs. The Panel recommended that the FDA approve two of the PMAs but not the third.
2000 - MayThe FDA approved the first PMAs for saline-filled breast implants. P990074 for Allergan (formerly McGhan) and P990075 for Mentor. These implants were approved for augmentation in women age 18 and older and for reconstruction in women of any age.
2000 - AugustThe FDA approved Mentor's IDE study (i.e., Core Study) for its silicone gel-filled breast implants for a limited number of augmentation, reconstruction, and revision patients at a limited number of sites. This is the Core Study for submission P030053.
2002 - JulyThe FDA held an Advisory Panel meeting to update the Panel on postmarket (after approval) information and data for the two approved saline-filled breast implant PMAs.
2002 - DecemberAllergan submitted a PMA (P020056) for its silicone gel-filled breast implants.
2003 - OctoberThe FDA held an Advisory Panel meeting to review Allergan’s PMA for its silicone gel-filled implants (P020056). In a 9 to 6 vote, the panel recommended approvable with conditions, including a minimum age requirement for augmentation.
2003 - DecemberMentor submitted a PMA (P030053) for its silicone gel-filled breast implants.
2005 - AprilThe FDA held an Advisory Panel meeting to review Allergan’s updated PMA and Mentor’s PMA. In a 5 to 4 vote, the panel did not recommend approval of Allergan's PMA (due to a concern with one style in the application). In a 7 to 2 vote, the panel recommended approvable with conditions for Mentor's PMA. The panel recommended that FDA require conditions including a minimum age requirement for augmentation and Post-Approval Studies.
2006 - NovemberThe FDA approved Allergan and Mentor’s PMAs for silicone gel-filled breast implants. This was the first time silicone gel-filled breast implants were available for augmentation, in addition to reconstruction and revision, since the moratorium was established in 1992. As conditions of approval, each manufacturer was required to conduct 6 post-approval studies to further characterize the safety and effectiveness of their silicone gel-filled breast implants and to answer scientific questions that the premarket clinical trials were not designed to answer.
2011 - JanuaryThe FDA issued a Safety Communication on anaplastic large cell lymphoma (ALCL) in women with breast implants. Based on a review of the scientific literature, the FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant.
2011 - JuneThe FDA issued an Update on the Safety of Silicone Gel-Filled Breast Implants. It included preliminary results of the post approval studies Allergan and Mentor were required to perform as conditions of their silicone gel-filled breast implant 2006 approval.
2011 - AugustThe FDA held an Advisory Panel meeting to discuss and receive recommendations on postmarketing issues related to silicone gel-filled breast implants. Also discussed at this meeting were innovative methodological approaches to postmarket studies regarding silicone gel breast implants, as well as key long-term safety issues associated with silicone gel breast implants in the real-world setting.
2012 - MarchThe FDA approved Sientra Inc.’s PMA for a silicone gel-filled breast implant. As a condition of approval, the manufacturer was required to conduct a series of post-approval studies to further characterize the safety and effectiveness of their silicone gel-filled breast implant and to answer scientific questions that the premarket clinical trial was not designed to answer.
2013 - FebruaryThe FDA approved Allergan's PMA for a silicone gel-filled breast implant that uses a more cohesive silicone gel, compared to their previously approved breast implant. As a condition of approval, the manufacturer was required to conduct a series of post-approval studies to further characterize the safety and effectiveness of their breast implant and to answer scientific questions that the premarket clinical trial was not designed to answer.
2013 - JuneThe FDA approved Mentor's PMA for a silicone gel-filled breast implant that uses a more cohesive silicone gel, compared to their previously approved breast implant. As a condition of approval, the manufacturer was required to conduct a series of post-approval studies to further characterize the safety and effectiveness of their breast implant and to answer scientific questions that the premarket clinical trial was not designed to answer.
2013年二月:
2013年六月:美國食藥署核可mentor提出的果凍矽膠上市前的申請。根據此項核可,製造商必需在矽膠上市後進行安全性與有效性的臨床試驗,以進一步了解在上市前研究中未能得到解答的科學性問題。
1988 美國食藥署將乳房植入物改歸類為第三類的醫療器材,必需進行上市前的臨床試驗與核可
1991 四月:美國食藥署發佈命令,Congress passed the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act. Breast implants were placed into Class II and reviewed through the premarket notification [510(k)] process.
1988In response to emerging safety concerns, the FDA re-classified breast implants to class III devices (requiring premarket approval). However, in accordance with the law, they continued to be reviewed through the 510(k) process until the FDA issued a rule calling for submission of premarket approval applications (PMAs).
1991 - AprilThe FDA issued a final rule calling for submission of PMAs for silicone gel-filled breast implants.
1991 - NovemberThe FDA held an Advisory Panel meeting to discuss several PMAs for silicone gel-filled breast implants. While the panel concluded that the manufacturers had failed to provide adequate safety and effectiveness data for their implants, they unanimously recommended that the FDA permit the implants to remain on the market.
1992 - JanuaryThe FDA announced a voluntary moratorium on silicone gel-filled breast implants, requesting that manufacturers stop supplying them and surgeons stop implanting them, while the FDA reviewed new safety and effectiveness information that had been submitted.
1992 - FebruaryBased on new information, the FDA held a second Panel meeting to re-evaluate the safety of silicone gel-filled breast implants. This time the panel recommended that silicone gel-filled breast implants be removed from the market pending further evaluation of the new data.
1992 - AprilThe FDA concluded:
- None of the PMAs submitted for silicone gel-filled breast implants contained sufficient data to support approval.
- Access to silicone gel-filled breast implants should continue for patients undergoing breast reconstruction or for replacement of existing silicone gel-filled breast implants (revision). Implants used for these indications should be considered to be investigational devices, and women who received them should be followed through adjunct clinical studies.
1992 - JulyThe FDA approved Mentor's Adjunct Study protocol for its silicone gel-filled breast implants for reconstruction and revision patients only.
1998 - MarchThe FDA approved Allergan’s (formerly Inamed) Adjunct Study protocol for its silicone gel-filled breast implants for reconstruction and revision patients only.
1998 - JuneThe FDA approved Allergan’s investigational device exemption (IDE) study (i.e., Core Study) for its silicone gel-filled breast implants for a limited number of augmentation, reconstruction, and revision patients at a limited number of sites. This is the Core Study for submission P020056.
2000 - MarchThe FDA held an Advisory Panel meeting to discuss three saline-filled breast implant PMAs. The Panel recommended that the FDA approve two of the PMAs but not the third.
2000 - MayThe FDA approved the first PMAs for saline-filled breast implants. P990074 for Allergan (formerly McGhan) and P990075 for Mentor. These implants were approved for augmentation in women age 18 and older and for reconstruction in women of any age.
2000 - AugustThe FDA approved Mentor's IDE study (i.e., Core Study) for its silicone gel-filled breast implants for a limited number of augmentation, reconstruction, and revision patients at a limited number of sites. This is the Core Study for submission P030053.
2002 - JulyThe FDA held an Advisory Panel meeting to update the Panel on postmarket (after approval) information and data for the two approved saline-filled breast implant PMAs.
2002 - DecemberAllergan submitted a PMA (P020056) for its silicone gel-filled breast implants.
2003 - OctoberThe FDA held an Advisory Panel meeting to review Allergan’s PMA for its silicone gel-filled implants (P020056). In a 9 to 6 vote, the panel recommended approvable with conditions, including a minimum age requirement for augmentation.
2003 - DecemberMentor submitted a PMA (P030053) for its silicone gel-filled breast implants.
2005 - AprilThe FDA held an Advisory Panel meeting to review Allergan’s updated PMA and Mentor’s PMA. In a 5 to 4 vote, the panel did not recommend approval of Allergan's PMA (due to a concern with one style in the application). In a 7 to 2 vote, the panel recommended approvable with conditions for Mentor's PMA. The panel recommended that FDA require conditions including a minimum age requirement for augmentation and Post-Approval Studies.
2006 - NovemberThe FDA approved Allergan and Mentor’s PMAs for silicone gel-filled breast implants. This was the first time silicone gel-filled breast implants were available for augmentation, in addition to reconstruction and revision, since the moratorium was established in 1992. As conditions of approval, each manufacturer was required to conduct 6 post-approval studies to further characterize the safety and effectiveness of their silicone gel-filled breast implants and to answer scientific questions that the premarket clinical trials were not designed to answer.
2011 - JanuaryThe FDA issued a Safety Communication on anaplastic large cell lymphoma (ALCL) in women with breast implants. Based on a review of the scientific literature, the FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant.
2011 - JuneThe FDA issued an Update on the Safety of Silicone Gel-Filled Breast Implants. It included preliminary results of the post approval studies Allergan and Mentor were required to perform as conditions of their silicone gel-filled breast implant 2006 approval.
2011 - AugustThe FDA held an Advisory Panel meeting to discuss and receive recommendations on postmarketing issues related to silicone gel-filled breast implants. Also discussed at this meeting were innovative methodological approaches to postmarket studies regarding silicone gel breast implants, as well as key long-term safety issues associated with silicone gel breast implants in the real-world setting.
2012 - MarchThe FDA approved Sientra Inc.’s PMA for a silicone gel-filled breast implant. As a condition of approval, the manufacturer was required to conduct a series of post-approval studies to further characterize the safety and effectiveness of their silicone gel-filled breast implant and to answer scientific questions that the premarket clinical trial was not designed to answer.
2013 - FebruaryThe FDA approved Allergan's PMA for a silicone gel-filled breast implant that uses a more cohesive silicone gel, compared to their previously approved breast implant. As a condition of approval, the manufacturer was required to conduct a series of post-approval studies to further characterize the safety and effectiveness of their breast implant and to answer scientific questions that the premarket clinical trial was not designed to answer.
2013 - JuneThe FDA approved Mentor's PMA for a silicone gel-filled breast implant that uses a more cohesive silicone gel, compared to their previously approved breast implant. As a condition of approval, the manufacturer was required to conduct a series of post-approval studies to further characterize the safety and effectiveness of their breast implant and to answer scientific questions that the premarket clinical trial was not designed to answer.
2013年二月:
2013年六月:美國食藥署核可mentor提出的果凍矽膠上市前的申請。根據此項核可,製造商必需在矽膠上市後進行安全性與有效性的臨床試驗,以進一步了解在上市前研究中未能得到解答的科學性問題。
Silicone Gel-Filled Breast Implants
Description:Silicone gel-filled breast implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells.
Silicone gel-filled breast implants are approved for breast augmentation in women age 22 or older and for breast reconstruction in women of any age. They are also used in revision surgeries, which correct or improve the result of an original surgery.
There are five silicone gel-filled breast implants that have been approved by the FDA:
The most frequent complications and adverse outcomes experienced by breast implant patients include capsular contracture, reoperation, and implant removal (with or without replacement). Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection. In addition, women with breast implants may have a very low but increased likelihood of being diagnosed with anaplastic large cell lymphoma (ALCL).
MRI continues to be an effective method of detecting silent rupture of silicone gel-filled breast implants. If you have silicone gel-filled breast implants, the FDA recommends that you receive MRI screening for silent rupture 3 years after receiving your implant and every 2 years after that.
There is no apparent association between silicone gel-filled breast implants and connective tissue disease, breast cancer, or reproductive problems. However, in order to definitively rule out these and other rare complications, studies would need to be much larger and longer than those conducted so far.
In June 2011, the FDA issued an Update on the Safety of Silicone Gel-Filled Breast Implants. This update included preliminary results of the studies required by the manufacturers at the time of approval as well as a review of other available scientific data.
The Summary of Safety and Effectiveness for each of the five approved silicone gel filled breast implants details safety information known at the time of FDA approval. As the FDA learns of new safety information, it requires companies to update their product labeling. The most current safety information about silicone gel-filled breast implants can be found in the labeling.
Description:Silicone gel-filled breast implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells.
Silicone gel-filled breast implants are approved for breast augmentation in women age 22 or older and for breast reconstruction in women of any age. They are also used in revision surgeries, which correct or improve the result of an original surgery.
There are five silicone gel-filled breast implants that have been approved by the FDA:
- Allergan Natrelle (Premarket application number: P020056) (Approved November 2006)
- Allergan Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Premarket application number: P040046) (Approved February 2013)
- Mentor MemoryGel (Premarket application number: P030053) (Approved November 2006)
- Mentor MemoryShape (Premarket application number: P060028) (Approved June 2013)
- Sientra’s Silicone Gel Breast Implants (Premarket application number: P070004) (Approved March 2012)
The most frequent complications and adverse outcomes experienced by breast implant patients include capsular contracture, reoperation, and implant removal (with or without replacement). Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection. In addition, women with breast implants may have a very low but increased likelihood of being diagnosed with anaplastic large cell lymphoma (ALCL).
MRI continues to be an effective method of detecting silent rupture of silicone gel-filled breast implants. If you have silicone gel-filled breast implants, the FDA recommends that you receive MRI screening for silent rupture 3 years after receiving your implant and every 2 years after that.
There is no apparent association between silicone gel-filled breast implants and connective tissue disease, breast cancer, or reproductive problems. However, in order to definitively rule out these and other rare complications, studies would need to be much larger and longer than those conducted so far.
In June 2011, the FDA issued an Update on the Safety of Silicone Gel-Filled Breast Implants. This update included preliminary results of the studies required by the manufacturers at the time of approval as well as a review of other available scientific data.
The Summary of Safety and Effectiveness for each of the five approved silicone gel filled breast implants details safety information known at the time of FDA approval. As the FDA learns of new safety information, it requires companies to update their product labeling. The most current safety information about silicone gel-filled breast implants can be found in the labeling.