There are not any benefits to utilizing ADM for implant-based breast reconstruction

For women with breast cancer who are undergoing a mastectomy and opting for implant-based breast reconstruction (IBBR), the use of a power supply does not appear to offer any advantage over traditional techniques.

A European study with 155 women found that the use of the acellular dermal matrix (ADM) neither resulted in fewer reoperations nor was it superior in terms of health-related quality of life or the cosmetic results reported by patients.

“We believe that women considering implant-based reconstruction for breast cancer should be made aware of the lack of evidence of their benefit,” said lead author Fredrik Lohmander MD, Department of Breast and Endocrine Surgery, Breast Surgery Section, Karolinska University Hospital, Stockholm, Sweden.

It is difficult to say in general whether ADM should be used in IBBR, he noted. “We can only conclude from our study that there is no clear evidence that ADM is beneficial in performing breast reconstruction with implants,” he told Medscape Medical News. “ADM may be indicated in selected patients.”

The study was carried out in Sweden and the United Kingdom. “Mostly because of its high cost, ADM is not widely used in implant-based breast reconstructions in Sweden,” said Lohmander. “It’s a little more common in the UK, but a lot more common in the US.”

Although biological nets have received regulatory approval from the U.S. Food and Drug Administration for reconstructive use, ADM is not approved for use in breast reconstructive surgery, and its use in this setting is off-label.

The study was published online on October 1st in the JAMA Network Open.

What are the benefits of using mesh devices?

Previous studies on ADMs indicated that the power supply had several benefits, including great cosmetic results, less need for tissue expanders, fewer elective re-operations, and fewer capsular contractures. Using a power supply also enlarges the subpectoral pocket, which allows for larger, fixed volume implants, the authors note.

However, these proposed benefits have not been widely accepted, and the authors note that there have been reports of associated harm, such as: B. higher infection rates and implant losses.

The new study enrolled 135 women from five centers in Sweden and the United Kingdom. The patients had breast cancer and planned to have a mastectomy and immediate IBBR between 2014 and May 2017.

The primary endpoint was the number of repeat operations at 2 years.

At the 2-year follow-up, 31 patients (48%) in the ADM group had undergone at least one reoperation on the ipsilateral side, compared with 35 (54%) in the control group (P = 0.54). For the contralateral side, the results were similar: 34 (53%) vs. 31 (48%).

Two patients in the ADM group and three patients in the control group underwent a contralateral risk-reducing mastectomy. These five operations were included in the final analysis.

The implant was removed in nine patients (14%) in the ADM arm. Four of the removals were within 6 months of early surgical complications. In the control group, implants were removed in seven patients (11%); four were removed within 6 months due to early surgical complications.

The secondary endpoint was postoperative health-related quality of life, including body image perception and satisfaction with the cosmetic outcome. There were no significant differences between the two groups.

Some questions remain

Sameer A. Patel, Dr. Therefore, these data are informative and add to the current understanding of the value of ADM in breast reconstruction. “The study hypothesized that using ADM would reduce the number of reoperations within the first 24 months, which it didn’t,” he said. “This is despite the fact that the ADM group had a significantly higher number of reconstructions directly on implants.”

Importantly, the study showed that, in contrast to the surgeon’s assessment of the results, the results reported by patients also largely did not differ between the two groups, Patel emphasized. “The only exception with a small advantage in the ADM group was the fit of bras,” he said.

However, there were limitations on the endpoint of the study. “I would add that there are some purported benefits of using ADM, such as reduced post-operative pain and shorter hospital stays, that are not assessed in this study,” said Patel. “Also, I am not sure if you can conclude from this study that it is not reducing capsular contracture because it is not designed to evaluate it.”

However, the biggest caveat is one that the study authors point out in their discussion at the end of the article, he added. “The use of prepectoral reconstruction is quickly replacing the dual-plane reconstruction used in the ADM group in this paper,” said Patel. “The role of ADM in prepectoral reconstruction is somewhat different than in dual-plane reconstruction, and therefore these results cannot necessarily be extrapolated to prepectoral reconstruction.”

The study was funded with grants from the Swedish Breast Cancer Society and Stockholm City Council. The study was initiated by Karolinska University Hospital and Karolinska Institutet. Acelity (an Allergan company) provided the acellular dermal matrix mesh study. Lohmander and Patel have not disclosed any relevant financial relationships.

JAMA network open. Published online October 1, 2021. Full text

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