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DAY THREE: The Father of the Pinnacle Mesh Kit

Dr. Dennis Miller, urogynecologist

Dr. Dennis Miller, urogynecologist

Mesh News Desk thanks the many donors and Herman Gerel Law and Saunders & Walker for their contributions to this coverage!

Dr. Dennis Miller is a Wisconsin based medical doctor. While he has extensive training as a urogynecologist, Dr. Miller also has another role – he works extensively with medical device manufacturers and is the inventor of the Pinnacle Pelvic mesh kit, made by Boston Scientific (BSC) which is the subject of a defective product litigation in a Miami federal courtroom.

Four women claim the Pinnacle, the largest mesh kit used to treat pelvic organ prolapse, caused complications including “erosion, mesh contraction, infection, fistula inflammation, scar tissue, organ perforation, dyspareunia, blood loss, neuropathic and other acute and chronic nerve damage and pain, pudendal nerve damage, pelvic floor damage, and chronic pelvic pain.”  Pretrial Order #91.

The plaintiffs allege negligence, design defect, manufacturing defect, failure to warn, breach of express warranty, breach of implied warranty, and punitive damages.” [Document #246].

Judge Joseph R. Goodwin, Charleston, WV

Judge Joseph R. Goodwin, Charleston, WV

Judge Joseph Goodwin oversees 66-thousand of product liability cases over mesh made by seven manufacturers. His Charleston, WV courtroom is the scene of another Boston Scientific trial over the Obtryx mid-urethral sling as this Miami case is underway.

Dr. Miller appeared via videotape before the nine jurors chosen for this trial, five men and four women.  Most appear to be paying attention with the possible exception of a blonde woman who sits in a slouched position and looks disinterested.sleeping juror

Dr. Miller said he actually developed the delivery system for the mesh that would be called the Pinnacle. He brought the idea of using the Polyform mesh (a sheet of Marlex) and combine it with the Capio, a small hooked device with better access deep into the pelvis to more effectively affix the prolapsing organs. Using the Capio, one could avoid passing trocars or long needles through the pelvic space in a blind procedure.

“In medicine less is more and you want to move forward with less complexity,” he said on videotape.

Miller approached the company in August of 2005 and the idea went into production. The Pinnacle was ready to launch in January of 2008.

Since then, Dr. Miller said he’s implanted 250 to 300 Pinnacle kits with “really good outcomes and satisfied patients by large.” He clams to still use polypropylene and implants as much as most surgeons in this country.

Dr. Dennis Miller

Dr. Dennis Miller

For his work and eventual patent of the Pinnacle, Dr. Miller would receive quarterly wire transfers into his bank account. Pinnacle made him a millionaire. Miller would be paid $2.97 million for his invention which doesn’t include the $375 an hour he would be paid to consult with BSC and work with doctors in gearing up marketing for Pinnacle.

In providing his bio, Dr. Miller said there were no doctors in his family. “We had all salesmen in our family, no doctors.’

Despite the fact that polypropylene was subject to shrinkage and degradation, there were no clinical trials on humans before the Pinnacle was marketed. “That’s correct,” said Dr. Miller.

To “keep things moving,” Dr. Miller would be joined by Drs. Nager, Rovner, Goldman and Tulikangas in forming a task force to craft a statement paper by the American Urogynecologic Society (AUGS) on mid-urethral slings (here).

Miller admitted he had no experience with using the transvaginal tape-obturator. His personal favorite slings were the Advantage and the Ethicon TVT.

“That’s why it’s important to have five draftees and to work with a large organization,” he said.

And what about complications?

Miller says when he removes mesh he has not seen mesh degrading. When pulling on it, it does not come apart. “We do not see clinical degradation of the mesh.”

Dr. Peggy Pence

Dr. Peggy Pence

Product Development

Peggy Pence appeared on the stand in the afternoon. Seen in the Linda Gross trial, Pence, a PhD is a consultant to the medical device and pharmaceutical industry helping companies develop their products for market. She as worked for 80 companies in her 40 year career. Dr. Pence advises companies on what sort of testing they will need to prove a product is safe and effective before its marketed.

Bench testing of a product and biologic compatibility- is that enough to test an implanted medical device? No said Pence, even animal studies alone would not be enough. Randomized controlled clinical trials in humans must be conducted to assure safety and efficacy.

Reminded of the ProteGen failure, Dr. Pence agreed the BSC had conducted an internal evaluation that resulted in the realization they needed to do clinical testing before marketing a new product.

Shelly Hutson, Clark Love Hutson

Shelly Hutson, Clark Love Hutson

Did they do that?, asked plaintiffs’ attorney Shelly Hutson.

“Objection,” shouted Molly Craig for BSC.

Overruled, said Judge Goodwin.

“No they did not,” said Pence.

Matthew Keenan, Shook Hardy & Bacon

Matthew Keenan, Shook Hardy & Bacon


Expert Compensation

On cross examination, Matthew Keenan, an attorney for BSC brought up the money issue – how much had she made in consulting for the plaintiffs’ attorneys in this litigation and in other cases?

Pence has appeared in at least three other cases as an expert including the Linda Gross trial in New Jersey last year.

“Your rate is $500 an hour?”

“That’s what my company charges,” she said.

Working with a display board, he added up the numbers. About $825-thousand in fees he figured she’d been paid as an expert in mesh litigation.

Dr. Pence was unapologetic. She said that was compensation for her time which has involved about 500 hours.

Dr. Konstantin Walmsley,a urogynecologist from New York City appeared on the stand in the afternoon… … more as our coverage continues. Thursday brings Dr. M. Tom Margolis to the stand for the plaintiffs via videotape!! Stay tuned!


  1. Aaron Leigh says:

    Gotta love Peggy! Man, that woman can hold her own. She’s my heroess!

  2. Disgusted says:

    It is unbelievable to me that the trials seem so “clinical” and cold. We’re talking flesh and blood and loss of life. It is just incredible that money is what is focused on. Testimony is important and I’d think that the reputation of the individual would have to be shown. The Dr. claims to have great success with this product, why don’t they check with all the people he implanted???? I’m sure some of them would not agree. All the facts do not come out. So the jury has to weigh credibility with $$$ figures. I hope they take Peggy’s testimony seriously and do not weigh payments more highly. We’re prone to think that buy off’s are regular in our country. The more money the more pay off. I know that we have some good people who are not in it for the money. Thank God.

    • Jane Akre says:

      Asking an expert how much they make is common for each side to do. There is an implication there but if someone is learned and credentialed, isn’t their time worth money? You wouldn’t want a bargain expert? People should not have to apologize for charging for their services, companies don’t!

  3. JCD says:

    Wouldn’t it be great if Peggy, or other expert witnesses, would forfeit her fees for the sake of justice to all mesh victims? Now that would speak volumes to the jury.

    • Jane Akre says:

      Or donate them to a mesh survivor fund to seek out surgeries!!! How about all experts and all mesh makers and all lawyers joining in!

      • Dawn says:

        Donating their pay would be amazing ! And how much power behind that move would speak volumes in court if they replied ,” yes, I make $500 an hour and will be donating to ” mesh removal R US” .. Wonderful thought ! Wish we could convince one of the upcoming expert witness’ to do that..

  4. Janet B says:

    Dr, Dennis Miller was my urogyn in 2010. He did not implant the BS Lynx mesh into me, but he removed it. The whole time, he treated my family and I like dirt. He doubted my excruciating pain. He told me I was “the only one” who had ever had these problems. He lied to me about mesh erosion, and told me the blue threads coming out of my vagina were “loose stitches.” He left me with no pain medication after surgery, because he was unfamiliar with the way narcotics work, and the fact that if you are on a narcotic, you need temporary additional medication after a surgery to cover the surgical pain. He was rude and demeaning to my husband and my father, both of whom stayed by my side throughout the surgery. He told me prior to mesh removal that he was only doing it “because I insisted” and that it wouldn’t help my pain. Prior to mesh removal, I was bedridden in excruciating pain. I couldn’t walk, sit, touch my legs together, and had to self cath because my urethra was swollen shut. Post surgery, all of the urethral pain and problems were gone – all I had to deal with was vaginal muscle spasm/nerve pain from the mesh. But even when I had great results with mesh removal, Dr. Miller refused to admit mesh could have been the cause. I now know 6 other Wisconsin women who have had mesh implanted by Dr. Miller – one within the past year. All of these women are having severe pain and problems. And he has told each of these women that “he’s never had a complication.” Well, we all know that is not true – I guess he doesn’t realize that we talk to each other. Horrible doctor, horrible man.

  5. Hope Pagano says:

    Thanks for you all your hard work on behalf of women all of the world. You are an amazing gift to the mesh community.

    Hope 🙂

  6. msm says:

    Dr. Miller would be joined by Drs. Nager, Rovner, Goldman and Tulikangas in forming a task force to craft a statement paper by the American Urogynecologic Society (AUGS) on mid-urethral slings (here).”

    Dr. Rovner mentioned above and also one of the proponents of mesh in the great mesh debate at this years AUGS conference is only a urologist and NOT a urogynecologist. He does not list a certification in Female Pelvic Medicine. How is he and expert?

    • Disgusted says:

      I read the report. It makes me sick. It is unbelievable that the products are still being sold with what we now know. I do not understand why it isn’t illegal. To use a product that is stated “do not even have temporary contact with human bodily fluids”, with no testing on humans and failed testing on animals to a great degree. To be maiming ten’s of thousands of women permanently and still advertising the public and doctor’s with prestigious affiliations such as AUGS behind it. The Hippocratic Oath is no longer valued and holding up your hand and swearing to tell the whole truth and nothing but the truth under perjury of law holds no sway either. All that is seen is $$$$ signs. I heard a study on the radio last night that 250/1000 people would drop their families for $10 million. 230/1000 would have sex with strangers for a week for that amount and sadly 70/1000 would kill another person for this. Our society is sick and we need healing.

  7. Kitty says:

    Only a Psychopath

  8. Anna Cantu says:

    I know it is wrong to wish ill on people, but I have heard that kidney stones for a man are the worse sort of pain….here’s hoping these idiot doctors, male or female have a few the size of a golf ball….

  9. Lisa E says:

    My urologist that did my implant in 2010 told me after my problems got worse,that I was watching too much TV….with my Boston scientific implant

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