- Posted March 21, 2010 by
The FDA HAS BEEN FUMBLING FOR DECADES: RESULTING IN THOUSANDS BEING INJURED! (Part two)
I had high hopes that after part one of this article series came out earlier this month, we would see the FDA scrambling to recall the many surgical mesh devices that had received clearance based on a recalled product over the past two decades. I couldn’t help but take notice when the March 10, 2010 U.S. Food and Drug Administration’s Enforcement Report came out nary a word was mentioned of recalls of any kind for surgical mesh. This despite the fact that I had already proven and published the results for the first eighteen mesh devices I had already researched; all of which I have proved were cleared upon the attributes of a recalled device.
I have continued researching, and have found many more mesh devices that the FDA cleared upon this premise to report on. The list is long, so let’s once again jump on the:
Surgical Mesh Clearance Merry-Go-Round Expose’:
It is important to again briefly reiterate the details of the recalled device of which I speak. On November 15, 1996, Boston Scientific was cleared to proceed to market with the ProteGen Sling, under clearance number K963226. Just two years and two months after receiving clearance, Boston Scientific on January 22, 1999 submitted a letter to the FDA initiating a recall of this product. The reason as stated in the FDA’s enforcement report of March 17, 1999 stated “Use of the ProteGen in the treatment of female urinary incontinence is associated with a higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended.”
1.) On August 31, 2000 American Medical Systems (AMS) applied for 510K clearance for the AMS Triangle™ Silicone Coated Sling and Surgical Mesh. On November 29, 2000 they received this clearance under 510K Clearance Number K002721. AMS had used as two of their five predicate devices the TriAngle Sling and the Mentor Sling.
a.) K002721, AMS Triangle™ Silicone Coated Sling à K980482, Triangle™ Sling à K972651, In-Sling à K963226, The ProteGen Sling.
b.) K002721, AMS Triangle™ Silicone Coated Sling à K980483, Mentor Suspend™ Sling àK963226, The ProteGen Sling.
2.) On August 13, 2001 Gynecare, a division of Ethicon, who is in and of itself a division of Johnson & Johnson applied for FDA 510 clearance for their device, GYNECARE Tension-Free Vaginal Tape (TVT) System with Accessories, (Blue System.) The FDA granted clearance on October 26, 2001 under K012628. One of the two predicate devices used was GYNECARE Tension-Free Vaginal Tape (TVT) System with Accessories. (There is a slight modification to the accessories and it appears the inclusion of the “blue” mesh)
a.) K012628, GYNECARE Tension-Free Vaginal Tape (TVT) System with Accessories, (Blue System) à K974098, GYNECARE Tension-Free Vaginal Tape (TVT) System with Accessories à K963226, The ProteGen Sling
3.) Corniche. L.L.C. applied for 510K clearance for their device the SAFYRE
Sling on January 4, 2002. Clearance was granted on March 21, 2002 under
K020007. All three devices used as predicates are linked to the ProteGen Sling.
a.) K020007, SAFYRE Sling à K011251, the SPARC Sling System à K974098, GYNECARE Tension-Free Vaginal Tape (TVT) System with Accessories à K963226, The ProteGen Sling
b.) K020007, SAFYRE Sling à K974098, GYNECARE Tension-Free Vaginal Tape (TVT) System with Accessories à K963226, The ProteGen Sling
c.) K020007, SAFYRE Sling àK010533, The BioSling à Either K012628 or K974098, GYNECARE Tension-Free Vaginal Tape (TVT) System with Accessories (number not specified in FDA Clearance) à K963226, The ProteGen Sling
4.) On April 7, 2003, Gyne Ideas, Ltd. Applied for clearance of the Gyne Ideas Minitape RP™. This device received clearance by the FDA under number K023898 on June 18, 2003. This company used seven predicate devices, four of which have been researched so far, and of the four, all are linked to the ProteGen Sling. This approval chain is as follows:
a.) K023898, Gyne Ideas Minitape RP™ àK974098, Tension-Free Vaginal Tape (TVT) System (Ethicon Inc.) à K963226, The ProteGen Sling
b.) K023898, Gyne Ideas Minitape RP™ à K010533, The BioSling à Either K012628 or K974098, GYNECARE Tension-Free Vaginal Tape (TVT) System with Accessories (number not specified in FDA Clearance) à K963226, The ProteGen Sling
c.) K023898, Gyne Ideas Minitape RP™ à K021263, SPARC Sling System à K020663, SPARC Sling System à K013355, SPARC Sling System à K011251, SPARC Sling System à K974098, GYNECARE Tension-Free Vaginal Tape (TVT) System à K963226, The ProteGen Sling
d.) The SAFYRE Sling as referenced in number 3 above
5.) A company out of Spain, Specialties Remeex International, s.l. applied for clearance of their bladder mesh device on December 24, 2003. Their device, called the Specialties Remeex International, s.l. Remeex System used only one device as its predicate device, Gynecare/Ethicon Pubourethral Sling, K974098. The FDA cleared the Remeex for market on January 15, 2004 under K033310. It took them a mere 22 days to approve this device, and this takes into account both the Christmas and New Year’s Holiday. Sixteen possible working days to clear a device to proceed to market that was to be permanently implanted in one’s body. Of course, the device the Remeex was predicated upon has already been shown to be directly linked to the recalled ProteGen Sling, K963226.
6.) November 13, 2003, Ethicon once again filed documents to modify their device. The GYNECARE TVT Obturator device used as its predicate the GYNECARE TVT device. The FDA cleared this device on December 8, 2003 under K033568. They used as their predicate one of the following: K012628, GYNECARE Tension-Free Vaginal Tape (TVT) System with Accessories, (Blue System) or K974098, GYNECARE Tension-Free Vaginal Tape (TVT) System with Accessories (number not specified in FDA Clearance) both of which are linked toà K963226, The ProteGen Sling.
7.) Sofradim Production, a company from Trevoux, France submitted documents to the FDA for clearance of the URETEX SUP® Device on May 5, 2004. TWELVE DAYS LATER, On May 17, 2004, this devices was cleared to go to market under K041176. Sofradim Production had listed as predicates to their device K974098, Ethicon’s TVT and K980483, the Mentor Sling; both devices tied directly to the ProteGen Sling. Sofradim also used a third device, Sofradim Parietene® Meshes, which I have yet to research.
8.) On July 20, 2004 AMS submitted paperwork for the SPARC™, MONARC™, BioArc SP™, and BioArc TO™ Sling Systems. Why they felt the need to combine all of these devices in one document remains to be seen. Strangely enough, AMS used predicate devices with the exact same names that had already received prior approval. The referenced predicates are as follows: SPARC™ Sling System, K021263, MONARC ™Sling System, K023516, BioArc SP™ Sling System, K030123 and the BioArc TO™ Sling System, K040538. All of the predicate devices were addressed in The FDA HAS BEEN FUMBLING FOR DECADES: RESULTING IN THOUSANDS BEING INJURED! (Part one), and all have been linked to the recalled ProteGen Sling. The FDA cleared the four combined sling systems under K041948 on August 11, 2004.
9.) AMS applied for clearance of their AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with Inhibizone™ on November 12, 2004 using as its predicate devices K002721, the first device referenced in this article, and the Mentor SUSPEND™ Sling, K980483 reference in part one of this article series. Both predicates are linked to the ProteGen Sling. The FDA cleared the InteMesh™ Silicone-Coated Sling and Surgical Mesh with Inhibizone™ on December 14, 2004.
10.) Mentor Corporation submitted documents that were received by the FDA on October 20, 2004 for clearance of their device, the Mentor ObTape™ Trans-obturator Surgical Kit. On November 9, 2004 this device too was cleared for market under K042851. Mentor had used as its predicate device the Mentor ObTape Trans-obturator Tape and Introducers which had been cleared under K031767 on June 17, 2003. One must note, the predicate had been approved after only one week by the FDA, the current device within 20 days. Both the old and new device can be linked to the ProteGen Sling.
It is absolutely dizzying trying to keep up with this Merry-Go-Round. Go get a cup of coffee, take a break, and then we’ll jump back on board.
Ah, much better!
11.) On January 24, 2005 Mentor again applied for yet another version of their bladder mesh. This device was to be called the Mentor Aris Trans-obturator Tape and Surgical Kit. Mentor had used as their predicates both devices listed in number 10 above, K031767 and K042851. Need I say again, both linked to the ProteGen? This new device received FDA clearance number K050148.
12.) Caldera Medical submitted documents for clearance of their
T-Sling, which were received by the FDA on December 19, 2005 citing substantial equivalence to Ethicon’s TVT, K012628 reference above in number 2; Tyco Healthcare’s IVS Tunneller, K010035, referenced in part one of this article series, both of which are tied to the ProteGen. Caldera Medical also used as its predicate Herniamesh T-Sling, K020652, which has not yet been researched. The FDA cleared the T-Sling for market on February 3, 2006 under FDA clearance number K050516.
13.) On June 9, 2005, AMS applied for clearance of the Monarc™, Monarc™ +, and Monarc™ C Subfascial Hammocks / BioArc TO™, BioArc™ TO +, and BioArc TO-C Subfascial Hammocks. These devices, again combined into one document received FDA clearance on July 8, 2005 under K051530. Predicate devices used to clear this/these device(s) were K023516, Monarc™ Subfascial Hammock and K040538, BioArc™ TO Subfascial Hammock. Both predicates were already referenced in article one of this series, and both have been tied to the ProteGen Sling.
I know, I know, I am beginning to sound like a broken record; but really, the facts speak for themselves.
14.) CL Medical, a company from Sainte Foy Les Lyon, France applied through the FDA for clearance of their device the I-STOP on June 9, 2005. The FDA cleared this device on August 11, 2005 under K051533. CL Medical used as predicates for the I-STOP the following:
K012628 - Gynecare TVT System: See number 2 above.
K013355 – SPARC Sling System: See the first article in this expose’ series.
K023516 – MONARC Sling System: See the first article in this expose’ series.
K033568 – Gynecare TVT-O System: See number 6 above.
K041176 – Uretex TO: See number 7 above.
K050148 – Mentor ARIS TOT: See number 11 above.
All six predicates are linked to the recalled ProteGen Sling.
15.) Gynecare, a division of Ethicon, Inc., (who is a subsidiary of Johnson & Johnson) submitted paperwork to the FDA for yet another TVT device on November 17, 2005. This “modified” device was called the GYNECARE TVT SECUR* System; on November 28, 2005 the FDA issued clearance under number K052401 allowing Gynecare to proceed to market with their new device.
Gynecare used as their predicate devices the GYNECARE TVT System, K974098 (referenced in article one of the Surgical Mesh Merry-Go-Round series; and theGYNECARE TVT Obturator System, K033568, (number 6 above.) Both devices, again, linked to the recalled ProteGen Sling.
16.) On November 25, 2005, Mentor Corporation submitted paperwork for clearance for the Mentor Aris™ Suprapubic Surgical Kit. Mentor cited substantial equivalence to K050148, the Mentor Aris Trans-obturator Tape and Surgical Kit, (reference in number 11 above.) They also cited substantial equivalence to the SPARC Sling System(s), K011251, K013355, K020663 and K021263. All four of these devices are referenced in this article series, part one. All five predicates are linked to the recalled ProteGen Sling.
Oh what tangled webs the FDA weaves. It is despicable that they continue to allow permanent implants to be approved in this manner, and all the while knowing that thousands of people are being injured.
17.) AMS, on December 14, 2006 applied for clearance of yet another bladder mesh device. Their Sub-Urethral Sling System; Surgical Mesh was issued FDA clearance on February 22, 2007 under K063713. AMS had cited as the predicates for this device the following:
K050516 – Caldera “T”-Sling, referenced above under number 12 above.
K023516 - Monarc™ Subfascial Hammock, referenced in article one of this series regarding the Mesh Merry-Go-Round Expose’.
K011251 – Sparc™ Sling System, also reference in article one.
All three predicates are linked to the recalled ProteGen Sling.
18. and 19.) On February 13, 2007, Mpathy Medical Devices Ltd., applied for clearances of the following two devices: The Modified Minitape* Urethral Sling and the Minitape™ Extra Urethral Sling. Both had used the same three predicate devices, and both were cleared for market within weeks under FDA clearance numbers K073646 and K073647 respectively. The “substantially equivalent” predicate devices are as follows:
K023898 – Minitape RP™ Urethral Sling: (Not yet researched)
K020007 – SAFYRE Sling: Referenced in number 3 above
K021262 – SPARC Sling System: Included in this article series, part one
The two devices that have been researched are tied to the ProteGen Sling.
It is important to note that some of these devices used additional predicate devices in the clearance process, of which I have not yet had time to research. It seems that every time I discover a surgical mesh device clearance, I uncover yet more 510K approval numbers that then need to be verified.
It is also important to recognize that all devices listed in both part one and two of the surgical mesh merry-go-round expose’ article series have one hundred percent been linked to the ProteGen Sling, a recalled device.
Though I really don’t like writing this type of article, because I think the redundancy in the material is not conducive to “good” writing, I do think what has been exposed is of great significance. This subject matter holds great importance for those who have been injured by surgical mesh, and giving people the knowledge I have attained is very important to me. Most people have never heard of the MAUDE Database, and wouldn’t have a clue as to how to go about researching specific devices once they have been injured by one. It would be pretty pointless anyway, because the MAUDE Database is not uniform, and sometimes many searches using different criteria must plugged into their search engine to obtain the maximum number of adverse events on file.
In addition, a great many people probably have no knowledge of the FDA’s 510K Clearance Process or how to go about researching that either. I spent a year and a half uncovering this Surgical Mesh Merry-Go-Round, and what I found is appalling. The FDA knows, (by virtue of the MAUDE Database) that thousands are being injured by these types of devices; they further know that the manner in which they are approving these devices is ludicrous, and yet they continue down this treacherous path.
In June of 2007, when I became injured, I found a blog on the TOPIX website where hundreds of women were posting about injuries they had sustained as a result of having had one or more of these products implanted.
It was after I was injured that I began researching in earnest, and began to offer to share what knowledge I had with surgical mesh victims. Since then, I have had many dozens of people contacting me for help, and on an individual basis, I shared what I knew. Then I thought to myself, it would probably be even more beneficial to the masses if I were to begin an article series exposing what I had learned. I will continue helping people on an individual basis; offering more than just what I have found in the mesh clearance chain. I have uncovered dozens of articles, many on my own and many with the help of other surgical mesh victims. These articles are mainly from Urology and Gynecological Journals and Expert Reviews, and they speak of the dangers of surgical mesh; the fact that injuries are under-reported; and that these products should not be recommended for implantation due to the lack of testing. No clinical trials were/are required before these products were/are unleashed on the public in mass.
The practice of clearing these devices continue today, using “substantially equivalent” devices as predicates, which can be tied back to a recalled device. The use of people as human guinea pigs is a sickening practice, and it needs to cease, NOW. Revamping the FDA is where healthcare reform needs to begin!
Please, be on the lookout for article three in the Surgical Mesh Merry-Go-Round Expose’ series, the FDA Has Been Fumbling For Decades; Resulting In Thousands Being Injured!
And, please consider signing the petition on behalf of surgical mesh victims on the Care2 Petition Site.
Article three, listing even more individual surgical mesh products will be posted in the next few weeks!